{"protocolSection":{"identificationModule":{"nctId":"NCT05890586","orgStudyIdInfo":{"id":"Pro00107921_B"},"secondaryIdInfos":[{"id":"3U24TR001608-05W1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/3U24TR001608-05W1"}],"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"ACTIV-6: COVID-19 Study of Repurposed Medications - Arm B (Fluvoxamine)","officialTitle":"ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications"},"statusModule":{"statusVerifiedDate":"2023-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-06-08","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-07-04","type":"ACTUAL"},"completionDateStruct":{"date":"2022-09-04","type":"ACTUAL"},"studyFirstSubmitDate":"2023-06-04","studyFirstSubmitQcDate":"2023-06-04","studyFirstPostDateStruct":{"date":"2023-06-06","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-07-03","resultsFirstSubmitQcDate":"2023-07-31","resultsFirstPostDateStruct":{"date":"2023-08-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-09-01","lastUpdatePostDateStruct":{"date":"2023-09-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Susanna Naggie, MD","investigatorTitle":"Associate Professor of Medicine","investigatorAffiliation":"Duke University"},"leadSponsor":{"name":"Susanna Naggie, MD","class":"OTHER"},"collaborators":[{"name":"National Center for Advancing Translational Sciences (NCATS)","class":"NIH"},{"name":"Vanderbilt University Medical Center","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person.\n\nPrior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include \"Pro00107921\" in the Unique Protocol ID.","detailedDescription":"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.\n\nThis proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.\n\nThis platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.\n\nParticipants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions.\n\nEligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized.\n\nAll study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary."},"conditionsModule":{"conditions":["Covid19"],"keywords":["SARS-CoV-2","COVID-19","Placebo","Duke University Health System","Outcomes","Duke Clinical Research Institute","fluvoxamine","ACTIV 6","ACTIV"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Double-Blind, Placebo-Controlled, Randomized Trial","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","maskingDescription":"The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.","whoMasked":["PARTICIPANT","CARE_PROVIDER"]}},"enrollmentInfo":{"count":1331,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Arm B - Fluvoxamine","type":"EXPERIMENTAL","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.","interventionNames":["Drug: Fluvoxamine"]},{"label":"Arm B - Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Fluvoxamine","description":"Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.","armGroupLabels":["Arm B - Fluvoxamine"],"otherNames":["Fluvoxamine Maleate Tablets"]},{"type":"OTHER","name":"Placebo","description":"Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.","armGroupLabels":["Arm B - Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to Sustained Recovery in Days","description":"Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.","timeFrame":"Up to 28 days"}],"secondaryOutcomes":[{"measure":"Number of Participants With Hospitalization or Death","timeFrame":"Up to 28 days"},{"measure":"Number of Participants With Mortality","timeFrame":"Up to 28 days"},{"measure":"Time to Mortality","description":"Time to mortality was the number of days between drug receipt and death.","timeFrame":"Up to 28 days"},{"measure":"Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death","timeFrame":"Up to 28 days"},{"measure":"Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7","description":"COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.","timeFrame":"Day 7"},{"measure":"Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14","description":"COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.","timeFrame":"Day 14"},{"measure":"Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28","description":"COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.","timeFrame":"Day 28"},{"measure":"Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function. Day 90 data to be reported by September 4, 2023.","timeFrame":"Day 7, 14, 28, and 90"},{"measure":"Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue. Day 90 data to be reported by September 4, 2023.","timeFrame":"Day 7, 14, 28, and 90"},{"measure":"Quality of Life (QOL) as Measured by the PROMIS-29 - Pain","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain. Day 90 data to be reported by September 4, 2023.","timeFrame":"Day 7, 14, 28, and 90"},{"measure":"Quality of Life (QOL) as Measured by the PROMIS-29 - Depression","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression. Day 90 data to be reported by September 4, 2023.","timeFrame":"Day 7, 14, 28, and 90"},{"measure":"Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.","timeFrame":"Day 7, 14, 28, and 90"},{"measure":"Quality of Life (QOL) as Measured by the PROMIS-29 - Social","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities. Day 90 data to be reported by September 4, 2023.","timeFrame":"Day 7, 14, 28, and 90"},{"measure":"Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep. Day 90 data to be reported by September 4, 2023.","timeFrame":"Day 7, 14, 28, and 90"},{"measure":"Time Unwell in Days as Measured by the Symptom and Clinical Event Scale","description":"The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.","timeFrame":"Up to 14 days"},{"measure":"Mean Days Benefit as Measured by the Symptom and Clinical Event Scale","description":"The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.","timeFrame":"Up to 14 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Completed Informed Consent\n* Age ≥ 30 years old\n* Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening\n* Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell\n\nExclusion Criteria:\n\n* Prior diagnosis of COVID-19 infection (\\> 10 days from screening)\n* Current or recent (within 10 days of screening) hospitalization\n* Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo\n* Known contraindication(s) to study drug including prohibited concomitant medications","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Susanna Naggie, MD","affiliation":"Duke Clinical Research Institute","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Adrian Hernandez, MD","affiliation":"Duke Clinical Research Institute","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Lamb Health, LLC","city":"Gilbert","state":"Arizona","zip":"85298","country":"United States","geoPoint":{"lat":33.35283,"lon":-111.78903}},{"facility":"First Care Medical Clinic","city":"Mesa","state":"Arizona","zip":"85203","country":"United States","geoPoint":{"lat":33.42227,"lon":-111.82264}},{"facility":"Trident Health Center","city":"Peoria","state":"Arizona","zip":"85382","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Hoag Memorial Hospital Presbyterian","city":"Newport Beach","state":"California","zip":"92663","country":"United States","geoPoint":{"lat":33.61891,"lon":-117.92895}},{"facility":"Assuta Family Medical Group APMC","city":"North Hollywood","state":"California","zip":"91606","country":"United States","geoPoint":{"lat":34.17223,"lon":-118.37897}},{"facility":"Stanford","city":"Palo Alto","state":"California","zip":"94304","country":"United States","geoPoint":{"lat":37.44188,"lon":-122.14302}},{"facility":"Doctors Medical Group of Colorado Springs, P.C.","city":"Colorado Springs","state":"Colorado","zip":"80917","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Pine Ridge Family Medicine Inc.","city":"Colorado Springs","state":"Colorado","zip":"80924","country":"United States","geoPoint":{"lat":38.83388,"lon":-104.82136}},{"facility":"Tabitha B. Fortt, M.D., LLC","city":"Stamford","state":"Connecticut","zip":"06905","country":"United States","geoPoint":{"lat":41.05343,"lon":-73.53873}},{"facility":"George Washington University Hospital","city":"Washington D.C.","state":"District of Columbia","zip":"20037","country":"United States","geoPoint":{"lat":38.89511,"lon":-77.03637}},{"facility":"Arena Medical Group","city":"Deerfield Beach","state":"Florida","zip":"33441","country":"United States","geoPoint":{"lat":26.31841,"lon":-80.09977}},{"facility":"Lupus Foundation of Gainesville","city":"Gainesville","state":"Florida","zip":"32606","country":"United States","geoPoint":{"lat":29.65163,"lon":-82.32483}},{"facility":"University of Florida Health","city":"Gainesville","state":"Florida","zip":"32611","country":"United States","geoPoint":{"lat":29.65163,"lon":-82.32483}},{"facility":"University of Florida-JAX-ASCENT","city":"Jacksonville","state":"Florida","zip":"32209","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"AMRON Vitality and Wellness Center, LLC","city":"Jacksonville","state":"Florida","zip":"32244","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Sunshine Walk In Clinic","city":"Lake Mary","state":"Florida","zip":"32746","country":"United States","geoPoint":{"lat":28.75888,"lon":-81.31784}},{"facility":"Lakeland Regional Medical Center","city":"Lakeland","state":"Florida","zip":"33805","country":"United States","geoPoint":{"lat":28.03947,"lon":-81.9498}},{"facility":"Jackson Memorial Hospital","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"University of Miami","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Well Pharma Medical Research","city":"Miami","state":"Florida","zip":"33173","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Innovation Clinical Trials Inc.","city":"Palmetto Bay","state":"Florida","zip":"33157","country":"United States","geoPoint":{"lat":25.62177,"lon":-80.32477}},{"facility":"Lice Source Services Plantation","city":"Plantation","state":"Florida","zip":"33313","country":"United States","geoPoint":{"lat":26.13421,"lon":-80.23184}},{"facility":"Premier Health","city":"St. Petersburg","state":"Florida","zip":"33707","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"Tallahassee Memorial Hospital","city":"Tallahassee","state":"Florida","zip":"32308","country":"United States","geoPoint":{"lat":30.43826,"lon":-84.28073}},{"facility":"Tampa General Hospital","city":"Tampa","state":"Florida","zip":"33606","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"UF Health Precision Health Research","city":"The Villages","state":"Florida","zip":"32159","country":"United States","geoPoint":{"lat":28.93408,"lon":-81.95994}},{"facility":"Emory Healthcare","city":"Atlanta","state":"Georgia","zip":"30322","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Essential Medical Care, Inc.","city":"College Park","state":"Georgia","zip":"30349","country":"United States","geoPoint":{"lat":33.65344,"lon":-84.44937}},{"facility":"David Kavtaradze MD, Inc.","city":"Cordele","state":"Georgia","zip":"31015","country":"United States","geoPoint":{"lat":31.96351,"lon":-83.78239}},{"facility":"Elite Family Practice","city":"Douglasville","state":"Georgia","zip":"30134","country":"United States","geoPoint":{"lat":33.7515,"lon":-84.74771}},{"facility":"Christ the King Health Care, P.C.","city":"Loganville","state":"Georgia","zip":"30052","country":"United States","geoPoint":{"lat":33.839,"lon":-83.90074}},{"facility":"Miller Family Practice, LLC","city":"Macon","state":"Georgia","zip":"31201","country":"United States","geoPoint":{"lat":32.84069,"lon":-83.6324}},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","zip":"60612","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Olivo Wellness Medical Center","city":"Chicago","state":"Illinois","zip":"60618","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"NorthShore Medical Group","city":"Evanston","state":"Illinois","zip":"60201","country":"United States","geoPoint":{"lat":42.04114,"lon":-87.69006}},{"facility":"Advanced Medical Care, Ltd","city":"Lake Zurich","state":"Illinois","zip":"60047","country":"United States","geoPoint":{"lat":42.19697,"lon":-88.09341}},{"facility":"Franciscan Health Michigan City","city":"Michigan City","state":"Indiana","zip":"46360","country":"United States","geoPoint":{"lat":41.70754,"lon":-86.89503}},{"facility":"Del Pilar Medical and Urgent Care","city":"Mishawaka","state":"Indiana","zip":"46545","country":"United States","geoPoint":{"lat":41.66199,"lon":-86.15862}},{"facility":"University of Kansas - Wichita","city":"Wichita","state":"Kansas","zip":"67214","country":"United States","geoPoint":{"lat":37.69224,"lon":-97.33754}},{"facility":"A New Start II, LLC","city":"Central City","state":"Kentucky","zip":"42330","country":"United States","geoPoint":{"lat":37.29393,"lon":-87.12333}},{"facility":"University Medical Center- New Orleans","city":"New Orleans","state":"Louisiana","zip":"70112","country":"United States","geoPoint":{"lat":29.95465,"lon":-90.07507}},{"facility":"Ochsner Clinic Foundation","city":"New Orleans","state":"Louisiana","zip":"70121","country":"United States","geoPoint":{"lat":29.95465,"lon":-90.07507}},{"facility":"Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","zip":"21287-1900","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Jadestone Clinical Research, LLC","city":"Rockville","state":"Maryland","zip":"20855","country":"United States","geoPoint":{"lat":39.084,"lon":-77.15276}},{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","zip":"02118","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Health Quality Primary Care","city":"Lawrence","state":"Massachusetts","zip":"01843","country":"United States","geoPoint":{"lat":42.70704,"lon":-71.16311}},{"facility":"Ananda Medical Clinic","city":"Dearborn","state":"Michigan","zip":"48124","country":"United States","geoPoint":{"lat":42.32226,"lon":-83.17631}},{"facility":"GFC of Southeastern Michigan, PC","city":"Detroit","state":"Michigan","zip":"48202","country":"United States","geoPoint":{"lat":42.33143,"lon":-83.04575}},{"facility":"Romancare Health Services","city":"Detroit","state":"Michigan","zip":"48206","country":"United States","geoPoint":{"lat":42.33143,"lon":-83.04575}},{"facility":"Essentia Health","city":"Duluth","state":"Minnesota","zip":"55805","country":"United States","geoPoint":{"lat":46.78327,"lon":-92.10658}},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","zip":"55455","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}},{"facility":"University of Missouri - Columbia","city":"Columbia","state":"Missouri","zip":"65212","country":"United States","geoPoint":{"lat":38.95171,"lon":-92.33407}},{"facility":"Comprehensive Pain Management and Endocrinology","city":"Henderson","state":"Nevada","zip":"89052","country":"United States","geoPoint":{"lat":36.0397,"lon":-114.98194}},{"facility":"Focus Clinical Research Solutions","city":"Bayonne","state":"New Jersey","zip":"07002","country":"United States","geoPoint":{"lat":40.66871,"lon":-74.11431}},{"facility":"Raritan Bay Primary Care & Cardiology Associates","city":"Matawan","state":"New Jersey","zip":"07747","country":"United States","geoPoint":{"lat":40.41483,"lon":-74.22959}},{"facility":"G&S Medical Associates, LLC","city":"Paterson","state":"New Jersey","zip":"07514","country":"United States","geoPoint":{"lat":40.91677,"lon":-74.17181}},{"facility":"Mediversity Healthcare","city":"Turnersville","state":"New Jersey","zip":"08012","country":"United States","geoPoint":{"lat":39.77317,"lon":-75.05128}},{"facility":"Geriatrics and Medical Associates","city":"Clinton","state":"New York","zip":"13323","country":"United States","geoPoint":{"lat":43.0484,"lon":-75.3785}},{"facility":"Weill Cornell Medical College","city":"New York","state":"New York","zip":"10065","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Spinal Pain and Medical Rehab, PC","city":"Yonkers","state":"New York","zip":"10701","country":"United States","geoPoint":{"lat":40.9304,"lon":-73.89789}},{"facility":"Vaidya MD PLLC","city":"Clayton","state":"North Carolina","zip":"27520","country":"United States","geoPoint":{"lat":35.65071,"lon":-78.45639}},{"facility":"Maria Medical Center, PLLC","city":"Dunn","state":"North Carolina","zip":"28334","country":"United States","geoPoint":{"lat":35.30627,"lon":-78.6089}},{"facility":"Duke Clinical Research Institute","city":"Durham","state":"North Carolina","zip":"27701","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","zip":"27710","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}},{"facility":"Wake Forest Baptist Health","city":"Winston-Salem","state":"North Carolina","zip":"27151","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"Diabetes and Endocrinology Assoc. of Stark County","city":"Canton","state":"Ohio","zip":"44718","country":"United States","geoPoint":{"lat":40.79895,"lon":-81.37845}},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","zip":"45267","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"TriHealth, Inc","city":"Montgomery","state":"Ohio","zip":"45242","country":"United States","geoPoint":{"lat":39.22811,"lon":-84.35411}},{"facility":"The Heart and Medical Center","city":"Durant","state":"Oklahoma","zip":"74701","country":"United States","geoPoint":{"lat":33.99399,"lon":-96.37082}},{"facility":"Hugo Medical clinic","city":"Hugo","state":"Oklahoma","zip":"74743","country":"United States","geoPoint":{"lat":34.01066,"lon":-95.50968}},{"facility":"Bucks County Clinical Research","city":"Morrisville","state":"Pennsylvania","zip":"19067","country":"United States","geoPoint":{"lat":40.2115,"lon":-74.78794}},{"facility":"Temple University Hospital","city":"Philadelphia","state":"Pennsylvania","zip":"19140","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","zip":"15213","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","zip":"29403","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"Clinical Trials Center of Middle TN","city":"Franklin","state":"Tennessee","zip":"37067","country":"United States","geoPoint":{"lat":35.92506,"lon":-86.86889}},{"facility":"Rapha Family Wellness","city":"Hendersonville","state":"Tennessee","zip":"37075","country":"United States","geoPoint":{"lat":36.30477,"lon":-86.62}},{"facility":"Medical Specialists of Knoxville","city":"Knoxville","state":"Tennessee","zip":"37938","country":"United States","geoPoint":{"lat":35.96064,"lon":-83.92074}},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","zip":"37203","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}},{"facility":"Express Family Clinic","city":"Allen","state":"Texas","zip":"75013","country":"United States","geoPoint":{"lat":33.10317,"lon":-96.67055}},{"facility":"DHR Health Institute for Research","city":"Edinburg","state":"Texas","zip":"78539","country":"United States","geoPoint":{"lat":26.30174,"lon":-98.16334}},{"facility":"Texas Tech University Health Sciences Center","city":"El Paso","state":"Texas","zip":"79905","country":"United States","geoPoint":{"lat":31.75872,"lon":-106.48693}},{"facility":"Texas Health Physicians Group","city":"Fort Worth","state":"Texas","zip":"76107","country":"United States","geoPoint":{"lat":32.72541,"lon":-97.32085}},{"facility":"Highlands Medical Associates, P.A.","city":"Highlands","state":"Texas","zip":"77562","country":"United States","geoPoint":{"lat":29.81884,"lon":-95.05604}},{"facility":"University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Family Practice Doctors P.A.","city":"Humble","state":"Texas","zip":"77338","country":"United States","geoPoint":{"lat":29.99883,"lon":-95.26216}},{"facility":"Texas Health Physicians Group","city":"Irving","state":"Texas","zip":"75039","country":"United States","geoPoint":{"lat":32.81402,"lon":-96.94889}},{"facility":"Kintex Group Texas LLC, DBA Activian Clinical Research","city":"Kingwood","state":"Texas","zip":"77339","country":"United States","geoPoint":{"lat":30.05691,"lon":-95.18349}},{"facility":"University Diagnostics and Treatment Clinic","city":"Pasadena","state":"Texas","zip":"77504","country":"United States","geoPoint":{"lat":29.69106,"lon":-95.2091}},{"facility":"University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Jeremy W. Szeto, D.O., P.A.","city":"Sugar Land","state":"Texas","zip":"77479","country":"United States","geoPoint":{"lat":29.61968,"lon":-95.63495}},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","zip":"22903","country":"United States","geoPoint":{"lat":38.02931,"lon":-78.47668}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"We will share this data after it has been de-identified. We will share data beginning around 6 months after publication and for up to 36 months afterward. Access will only be shared with those who have obtained prior IRB approval to be able to access this data.","infoTypes":["SAP","CSR"],"timeFrame":"Up to 36 months after publication","accessCriteria":"Interested investigators will need to seek prior IRB approval before access to any data is granted."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"FG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"686"},{"groupId":"FG001","numSubjects":"645"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"676"},{"groupId":"FG001","numSubjects":"615"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"30"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Participants with Baseline Characteristics data collected.","groups":[{"id":"BG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"BG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"646"},{"groupId":"BG001","value":"583"},{"groupId":"BG002","value":"1229"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47","lowerLimit":"38","upperLimit":"57"},{"groupId":"BG001","value":"47","lowerLimit":"39","upperLimit":"58"},{"groupId":"BG002","value":"47","lowerLimit":"38","upperLimit":"57"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Sex/Gender","categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"372"},{"groupId":"BG001","value":"327"},{"groupId":"BG002","value":"699"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"273"},{"groupId":"BG001","value":"254"},{"groupId":"BG002","value":"527"}]},{"title":"Prefer Not to Answer the Question","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"113"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"206"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"533"},{"groupId":"BG001","value":"490"},{"groupId":"BG002","value":"1023"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"72"}]},{"title":"Black, African American, or African","measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"82"}]},{"title":"Middle Eastern or North African","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"508"},{"groupId":"BG001","value":"462"},{"groupId":"BG002","value":"970"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"25"}]},{"title":"None of the above","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"41"}]},{"title":"Prefer not to answer","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"19"}]},{"title":"No response","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"10"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"646"},{"groupId":"BG001","value":"583"},{"groupId":"BG002","value":"1229"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time to Sustained Recovery in Days","description":"Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"days","timeFrame":"Up to 28 days","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"646"},{"groupId":"OG001","value":"583"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12","lowerLimit":"11","upperLimit":"14"},{"groupId":"OG001","value":"13","lowerLimit":"12","upperLimit":"13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.","paramType":"Hazard Ratio (HR)","paramValue":"0.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.86","ciUpperLimit":"1.07","estimateComment":"Hazard ratios greater than one favored the active intervention for a faster time to recovery."}]},{"type":"SECONDARY","title":"Number of Participants With Hospitalization or Death","populationDescription":"Data not collected on one participant.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 28 days","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"646"},{"groupId":"OG001","value":"582"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"No hypothesis test or decision rule was evaluated.","paramType":"Hazard Ratio (HR)","paramValue":"0.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.03","ciUpperLimit":"2.88","estimateComment":"Low event rate precluded covariate adjustment."}]},{"type":"SECONDARY","title":"Number of Participants With Mortality","populationDescription":"Data not collected on one participant.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 28 days","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"646"},{"groupId":"OG001","value":"582"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Time to Mortality","description":"Time to mortality was the number of days between drug receipt and death.","populationDescription":"Data not collected on one participant.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"Up to 28 days","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"646"},{"groupId":"OG001","value":"582"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Per the protocol/SAP, this endpoint is only analyzed if the number of total events exceeds 30. Due to the low event rate, the statistical analysis was not completed."}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death","populationDescription":"Data not collected on one participant.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 28 days","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"646"},{"groupId":"OG001","value":"582"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"No hypothesis test or decision rule was evaluated.","paramType":"Hazard Ratio (HR)","paramValue":"1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.6","ciUpperLimit":"1.7","estimateComment":"Hazard ratios less than one favor the active intervention of inhaled fluticasone furoate. The interval is a highest density credible interval."}]},{"type":"SECONDARY","title":"Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7","description":"COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.","populationDescription":"Data not collected on 7 participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 7","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"642"},{"groupId":"OG001","value":"580"}]}],"classes":[{"categories":[{"title":"0 = No clinical or virological evidence of infection","measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"34"}]},{"title":"1 = No limitation of activities","measurements":[{"groupId":"OG000","value":"542"},{"groupId":"OG001","value":"511"}]},{"title":"2 = Limitation of activities","measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"33"}]},{"title":"3 = Hospitalized, no oxygen therapy","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]},{"title":"4 = Hospitalized, on oxygen by mask or nasal prongs","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]},{"title":"5 = Hospitalized, on non-invasive ventilation or high-flow oxygen","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"6 = Hospitalized, on intubation and mechanical ventilation","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"8 = Death","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"No hypothesis test or decision rule was evaluated.","paramType":"Odds Ratio (OR)","paramValue":"1.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.74","ciUpperLimit":"1.98","estimateComment":"The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors."}]},{"type":"SECONDARY","title":"Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14","description":"COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.","populationDescription":"Data not collected on 17 participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 14","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"636"},{"groupId":"OG001","value":"576"}]}],"classes":[{"categories":[{"title":"0 = No clinical or virological evidence of infection","measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"37"}]},{"title":"1 = No limitation of activities","measurements":[{"groupId":"OG000","value":"574"},{"groupId":"OG001","value":"518"}]},{"title":"2 = Limitation of activities","measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"21"}]},{"title":"3 = Hospitalized, no oxygen therapy","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"4 = Hospitalized, on oxygen by mask or nasal prongs","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"5 = Hospitalized, on non-invasive ventilation or high-flow oxygen","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"6 = Hospitalized, on intubation and mechanical ventilation","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"8 = Death","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"No hypothesis test or decision rule was evaluated.","paramType":"Odds Ratio (OR)","paramValue":"1.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.53","ciUpperLimit":"2.06","estimateComment":"The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors."}]},{"type":"SECONDARY","title":"Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28","description":"COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.","populationDescription":"Data not collected on 29 participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Day 28","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"630"},{"groupId":"OG001","value":"570"}]}],"classes":[{"categories":[{"title":"0 = No clinical or virological evidence of infection","measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"30"}]},{"title":"1 = No limitation of activities","measurements":[{"groupId":"OG000","value":"569"},{"groupId":"OG001","value":"528"}]},{"title":"2 = Limitation of activities","measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"12"}]},{"title":"3 = Hospitalized, no oxygen therapy","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"4 = Hospitalized, on oxygen by mask or nasal prongs","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"5 = Hospitalized, on non-invasive ventilation or high-flow oxygen","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"6 = Hospitalized, on intubation and mechanical ventilation","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO)","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"8 = Death","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"No hypothesis test or decision rule was evaluated.","paramType":"Odds Ratio (OR)","paramValue":"1.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.74","ciUpperLimit":"2.22","estimateComment":"The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors."}]},{"type":"SECONDARY","title":"Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function. Day 90 data to be reported by September 4, 2023.","populationDescription":"Participants who responded to the quality of life survey at each timepoint.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 7, 14, 28, and 90","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"686"},{"groupId":"OG001","value":"645"}]}],"classes":[{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"586"},{"groupId":"OG001","value":"544"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20","lowerLimit":"16","upperLimit":"20"},{"groupId":"OG001","value":"20","lowerLimit":"17","upperLimit":"20"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"597"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20","lowerLimit":"19","upperLimit":"20"},{"groupId":"OG001","value":"20","lowerLimit":"19","upperLimit":"20"}]}]},{"title":"Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20","lowerLimit":"20","upperLimit":"20"},{"groupId":"OG001","value":"20","lowerLimit":"20","upperLimit":"20"}]}]},{"title":"Day 90","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"584"},{"groupId":"OG001","value":"530"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20","lowerLimit":"20","upperLimit":"20"},{"groupId":"OG001","value":"20","lowerLimit":"20","upperLimit":"20"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.51","ciUpperLimit":"0.83","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 14","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"1.21","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 28","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.55","ciUpperLimit":"1.03","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 90","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.68","ciUpperLimit":"1.39","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."}]},{"type":"SECONDARY","title":"Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue. Day 90 data to be reported by September 4, 2023.","populationDescription":"Participants who responded to the quality of life survey at each timepoint.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 7, 14, 28, and 90","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"686"},{"groupId":"OG001","value":"645"}]}],"classes":[{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"586"},{"groupId":"OG001","value":"544"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8","lowerLimit":"7","upperLimit":"12"},{"groupId":"OG001","value":"8","lowerLimit":"7","upperLimit":"12"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"597"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7","lowerLimit":"4","upperLimit":"9"},{"groupId":"OG001","value":"7","lowerLimit":"4","upperLimit":"8"}]}]},{"title":"Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.5","lowerLimit":"4","upperLimit":"8"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"8"}]}]},{"title":"Day 90","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"583"},{"groupId":"OG001","value":"530"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"8"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.04","ciUpperLimit":"1.60","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 14","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.98","ciUpperLimit":"1.51","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 28","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.84","ciUpperLimit":"1.35","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 90","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.92","ciUpperLimit":"1.47","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."}]},{"type":"SECONDARY","title":"Quality of Life (QOL) as Measured by the PROMIS-29 - Pain","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain. Day 90 data to be reported by September 4, 2023.","populationDescription":"Participants who responded to the quality of life survey at each timepoint.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 7, 14, 28, and 90","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"686"},{"groupId":"OG001","value":"645"}]}],"classes":[{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"586"},{"groupId":"OG001","value":"544"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"8"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"8"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"597"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"6"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"5"}]}]},{"title":"Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"4"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"4"}]}]},{"title":"Day 90","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"583"},{"groupId":"OG001","value":"530"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"4"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.80","ciUpperLimit":"1.29","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 14","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.84","ciUpperLimit":"1.47","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 28","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.80","ciUpperLimit":"1.46","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 90","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.77","ciUpperLimit":"1.44","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."}]},{"type":"SECONDARY","title":"Quality of Life (QOL) as Measured by the PROMIS-29 - Depression","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression. Day 90 data to be reported by September 4, 2023.","populationDescription":"Participants who responded to the quality of life survey at each timepoint.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 7, 14, 28, and 90","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"686"},{"groupId":"OG001","value":"645"}]}],"classes":[{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"586"},{"groupId":"OG001","value":"544"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"6"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"6"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"596"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"5"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"5"}]}]},{"title":"Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"4"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"5"}]}]},{"title":"Day 90","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"583"},{"groupId":"OG001","value":"530"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"4"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"1.16","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 14","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.63","ciUpperLimit":"1.10","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 28","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.73","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.54","ciUpperLimit":"0.99","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 90","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.66","ciUpperLimit":"1.18","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."}]},{"type":"SECONDARY","title":"Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.","populationDescription":"Participants who responded to the quality of life survey at each timepoint.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 7, 14, 28, and 90","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"686"},{"groupId":"OG001","value":"645"}]}],"classes":[{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"586"},{"groupId":"OG001","value":"544"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5","lowerLimit":"4","upperLimit":"7"},{"groupId":"OG001","value":"5","lowerLimit":"4","upperLimit":"8"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"597"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"6"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"6"}]}]},{"title":"Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"5"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"5"}]}]},{"title":"Day 90","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"584"},{"groupId":"OG001","value":"530"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4","lowerLimit":"4","upperLimit":"5"},{"groupId":"OG001","value":"4","lowerLimit":"4","upperLimit":"5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.85","ciUpperLimit":"1.37","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 14","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.85","ciUpperLimit":"1.44","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 28","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.93","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"1.24","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 90","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.78","ciUpperLimit":"1.37","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."}]},{"type":"SECONDARY","title":"Quality of Life (QOL) as Measured by the PROMIS-29 - Social","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities. Day 90 data to be reported by September 4, 2023.","populationDescription":"Participants who responded to the quality of life survey at each timepoint.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 7, 14, 28, and 90","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"686"},{"groupId":"OG001","value":"645"}]}],"classes":[{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"586"},{"groupId":"OG001","value":"544"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.5","lowerLimit":"14","upperLimit":"20"},{"groupId":"OG001","value":"18","lowerLimit":"14","upperLimit":"20"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"597"},{"groupId":"OG001","value":"541"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20","lowerLimit":"16","upperLimit":"20"},{"groupId":"OG001","value":"20","lowerLimit":"16","upperLimit":"20"}]}]},{"title":"Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20","lowerLimit":"18","upperLimit":"20"},{"groupId":"OG001","value":"20","lowerLimit":"18","upperLimit":"20"}]}]},{"title":"Day 90","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"583"},{"groupId":"OG001","value":"530"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20","lowerLimit":"19","upperLimit":"20"},{"groupId":"OG001","value":"20","lowerLimit":"19","upperLimit":"20"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.84","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.68","ciUpperLimit":"1.05","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 14","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"1.11","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 28","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.93","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.72","ciUpperLimit":"1.21","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 90","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.75","ciUpperLimit":"1.29","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."}]},{"type":"SECONDARY","title":"Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep","description":"The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep. Day 90 data to be reported by September 4, 2023.","populationDescription":"Participants who responded to the quality of life survey at each timepoint.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"score on a scale","timeFrame":"Day 7, 14, 28, and 90","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"686"},{"groupId":"OG001","value":"645"}]}],"classes":[{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"586"},{"groupId":"OG001","value":"544"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10","lowerLimit":"8","upperLimit":"12"},{"groupId":"OG001","value":"10","lowerLimit":"7","upperLimit":"12"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"596"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9","lowerLimit":"6","upperLimit":"12"},{"groupId":"OG001","value":"9","lowerLimit":"6","upperLimit":"11"}]}]},{"title":"Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"590"},{"groupId":"OG001","value":"542"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8","lowerLimit":"6","upperLimit":"11"},{"groupId":"OG001","value":"8","lowerLimit":"6","upperLimit":"11"}]}]},{"title":"Day 90","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"583"},{"groupId":"OG001","value":"530"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8","lowerLimit":"6","upperLimit":"11"},{"groupId":"OG001","value":"8","lowerLimit":"6","upperLimit":"10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio, log","paramValue":"1.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.05","ciUpperLimit":"1.60","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 14","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.00","ciUpperLimit":"1.52","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 28","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"1.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.84","ciUpperLimit":"1.27","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 90","nonInferiorityType":"OTHER","nonInferiorityComment":"Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.","paramType":"Odds Ratio (OR)","paramValue":"0.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.80","ciUpperLimit":"1.21","estimateComment":"Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval."}]},{"type":"SECONDARY","title":"Time Unwell in Days as Measured by the Symptom and Clinical Event Scale","description":"The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"Up to 14 days","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"646"},{"groupId":"OG001","value":"583"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.21","lowerLimit":"11.03","upperLimit":"11.42"},{"groupId":"OG001","value":"11.28","lowerLimit":"11.10","upperLimit":"11.48"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis is exploratory. No hypothesis test or decision rule was evaluated.","nonInferiorityType":"SUPERIORITY","paramType":"Difference in model estimate time unwell","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.43","ciUpperLimit":"0.31","estimateComment":"The interval is a highest-density credible interval."}]},{"type":"SECONDARY","title":"Mean Days Benefit as Measured by the Symptom and Clinical Event Scale","description":"The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"Up to 14 days","groups":[{"id":"OG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."},{"id":"OG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"646"},{"groupId":"OG001","value":"583"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.45","lowerLimit":"3.23","upperLimit":"3.70"},{"groupId":"OG001","value":"3.37","lowerLimit":"3.14","upperLimit":"3.60"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis is exploratory. No hypothesis test or decision rule was evaluated.","nonInferiorityType":"SUPERIORITY","paramType":"Difference in model estimated means","paramValue":"0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.37","ciUpperLimit":"0.52","estimateComment":"The interval is a highest-density credible interval."}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Up to 90 days","description":"Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90. Per the protocol, non-serious Adverse Events may be reported by the participant, but will not be further assessed by the site or study personnel unless the event meets the criteria of an event of special interest. There are no defined events of special interest for the fluvoxamine 50 cohort.","eventGroups":[{"id":"EG000","title":"Arm B - Fluvoxamine 50","description":"Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.\n\nFluvoxamine: Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has \"APO\" and the other side has \"F50\" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.","deathsNumAffected":0,"deathsNumAtRisk":676,"seriousNumAffected":3,"seriousNumAtRisk":676,"otherNumAffected":0,"otherNumAtRisk":676},{"id":"EG001","title":"Arm B - Placebo","description":"Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.\n\nPlacebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.","deathsNumAffected":0,"deathsNumAtRisk":615,"seriousNumAffected":6,"seriousNumAtRisk":615,"otherNumAffected":0,"otherNumAtRisk":615}],"seriousEvents":[{"term":"COVID-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":676},{"groupId":"EG001","numAffected":1,"numAtRisk":615}]},{"term":"Coronary vasospasm","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":676},{"groupId":"EG001","numAffected":1,"numAtRisk":615}]},{"term":"COPD exacerbation","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":676},{"groupId":"EG001","numAffected":0,"numAtRisk":615}]},{"term":"Diabetes mellitus","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":676},{"groupId":"EG001","numAffected":1,"numAtRisk":615}]},{"term":"Ophthalmic migraine","organSystem":"Eye disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":676},{"groupId":"EG001","numAffected":1,"numAtRisk":615}]},{"term":"Broken ankle","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":676},{"groupId":"EG001","numAffected":1,"numAtRisk":615}]},{"term":"Infected finger","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":676},{"groupId":"EG001","numAffected":0,"numAtRisk":615}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":676},{"groupId":"EG001","numAffected":1,"numAtRisk":615}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Susanna Naggie, MD, MHS, FIDSA","organization":"Duke University","email":"susanna.naggie@duke.edu","phone":"919-684-2584"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-07-06","uploadDate":"2023-08-02T10:35","filename":"Prot_005.pdf","size":1954755},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2022-04-01","uploadDate":"2023-07-25T07:07","filename":"SAP_003.pdf","size":768934},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2022-01-07","uploadDate":"2023-07-25T07:07","filename":"ICF_004.pdf","size":438994}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2023-07-25","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D000086382","term":"COVID-19"}],"ancestors":[{"id":"D011024","term":"Pneumonia, Viral"},{"id":"D011014","term":"Pneumonia"},{"id":"D012141","term":"Respiratory Tract Infections"},{"id":"D007239","term":"Infections"},{"id":"D014777","term":"Virus Diseases"},{"id":"D018352","term":"Coronavirus Infections"},{"id":"D003333","term":"Coronaviridae Infections"},{"id":"D030341","term":"Nidovirales Infections"},{"id":"D012327","term":"RNA Virus Infections"},{"id":"D008171","term":"Lung Diseases"},{"id":"D012140","term":"Respiratory Tract Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D016666","term":"Fluvoxamine"}],"ancestors":[{"id":"D010091","term":"Oximes"},{"id":"D006898","term":"Hydroxylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}