{"protocolSection":{"identificationModule":{"nctId":"NCT04342663","orgStudyIdInfo":{"id":"202004023"},"organization":{"fullName":"Washington University School of Medicine","class":"OTHER"},"briefTitle":"A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection","officialTitle":"A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection","acronym":"STOP COVID"},"statusModule":{"statusVerifiedDate":"2021-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-04-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-08-20","type":"ACTUAL"},"completionDateStruct":{"date":"2020-12-12","type":"ACTUAL"},"studyFirstSubmitDate":"2020-04-08","studyFirstSubmitQcDate":"2020-04-08","studyFirstPostDateStruct":{"date":"2020-04-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-07-01","resultsFirstSubmitQcDate":"2021-07-07","resultsFirstPostDateStruct":{"date":"2021-07-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-07-07","lastUpdatePostDateStruct":{"date":"2021-07-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Eric Lenze","investigatorTitle":"Wallace and Lucille Renard Professor of Psychiatry","investigatorAffiliation":"Washington University School of Medicine"},"leadSponsor":{"name":"Washington University School of Medicine","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use.\n\nThis study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.","detailedDescription":"We will consent approximately 152 participants, age 18 and older, who have tested tested positive for COVID-19 and are currently experiencing mild symptoms. All interactions for this study will be conducted remotely by videoconferencing, email, or phone.\n\nScreening: All participants will first complete a pre-screen to see if they may be eligible for the study. Once a participant is confirmed eligible and consented, the study team will send the study materials. These materials will consist of study medication and self-monitoring equipment, including a pregnancy test (for females of childbearing age not using contraception), an oxygen saturation monitor, blood pressure monitor, and thermometer. Once the study team has finalized the screening process, the participant will begin taking the study medication.\n\nRCT: Participants will be randomly assigned (1:1) to take either fluvoxamine or a placebo. This phase of the study will last approximately 15 days and is double-blinded. Participants will take 100mg of fluvoxamine or placebo by mouth three times a day for a daily total of 300mg. They will continue this dose for approximately 15 days. Depending on tolerability, the dose may be adjusted. Participants will also complete short 10-15 minute assessments daily to assess symptoms, results of self-monitoring (including oxygen level, blood pressure, and temperature) and any adverse events.\n\nOpen-label Phase: After completing the randomization phase, participants will then participate in an open-label phase (participant will definitely receive fluvoxamine) that will last up to 15 days. Those randomized to placebo will have the opportunity to try fluvoxamine during this time. Those randomized to fluvoxamine will continue this medication while slowly decreasing the drug. The participant may opt out of this phase. The dosage during this time will be 50-100mg two times daily until discontinuing the drug.\n\nFollow-up Phase: We will follow participants for approximately 30 days after the end of the randomized phase. If needed, the study team will review medical records to determine the clinical course of participants."},"conditionsModule":{"conditions":["COVID 19","Coronavirus"],"keywords":["COVID 19","fluvoxamine"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":152,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Fluvoxamine","type":"EXPERIMENTAL","description":"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.","interventionNames":["Drug: Fluvoxamine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Fluvoxamine","description":"Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.","armGroupLabels":["Fluvoxamine"],"otherNames":["Luvox"]},{"type":"DRUG","name":"Placebo","description":"Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Met Clinical Worsening","description":"Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (\\<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation \\>92%.","timeFrame":"RCT (approximately 15 days)"}],"secondaryOutcomes":[{"measure":"Clinical Deterioration on a Likert-type Scale (0-6)","description":"(0) none; (1) moderate severity of illness as defined by O2 saturation \\<92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation \\<92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.","timeFrame":"RCT (approximately 15 days)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. men and woman age 18 and older;\n2. Not hospitalized;\n3. Has recently tested SARS-CoV-2 (COVID-19 virus) positive.\n4. Currently symptomatic with one or more of one or more of the following symptoms: fever, cough, myalgia, mild dyspnea, diarrhea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat.\n5. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Illness severe enough to require hospitalization or already meeting study's primary endpoint for clinical worsening.\n2. Unstable medical comorbidities including, but not limited to: Severe underlying lung disease (COPD on home oxygen, interstitial lung disease, pulmonary hypertension), decompensated cirrhosis, Congestive heart failure (stage 3 or 4 per patient report and/or medical records).\n3. Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose steroids (\\>20mg prednisone per day)\n4. Unable to provide informed consent (eg moderate-severe dementia diagnosis)\n5. Unable to perform the study procedures","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Eric J Lenze, MD","affiliation":"Washington University School of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"BJC","city":"Belleville","state":"Illinois","zip":"62220","country":"United States","geoPoint":{"lat":38.52005,"lon":-89.98399}},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","zip":"63110","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}}]},"referencesModule":{"references":[{"pmid":"33240091","type":"DERIVED","citation":"Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020."},{"pmid":"33180097","type":"DERIVED","citation":"Lenze EJ, Mattar C, Zorumski CF, Stevens A, Schweiger J, Nicol GE, Miller JP, Yang L, Yingling M, Avidan MS, Reiersen AM. Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2292-2300. doi: 10.1001/jama.2020.22760."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Fluvoxamine","description":"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.\n\nFluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."},{"id":"FG001","title":"Placebo","description":"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.\n\nPlacebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"72"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"53"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"19"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Fluvoxamine","description":"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.\n\nFluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."},{"id":"BG001","title":"Placebo","description":"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.\n\nPlacebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"80"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"152"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46","lowerLimit":"35","upperLimit":"58"},{"groupId":"BG001","value":"45","lowerLimit":"36","upperLimit":"54"},{"groupId":"BG002","value":"46","lowerLimit":"36","upperLimit":"57"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"53"},{"groupId":"BG002","value":"109"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"43"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"66"},{"groupId":"BG002","value":"141"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"38"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"106"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Co-existing conditions","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Asthma","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"26"}]}]},{"title":"Hypertension","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]}]},{"title":"Diabetes","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"17"}]}]},{"title":"High cholesterol","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"14"}]}]},{"title":"Hyperthyroidism","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"}]}]},{"title":"Anxiety","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"}]}]},{"title":"Arthritis","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]}]},{"title":"Depression","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"5"}]}]}]},{"title":"Body mass index category","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Underweight (<18.5)","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]},{"title":"Normal (18.5-24.9)","categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"21"}]}]},{"title":"Overweight (25-29.9)","categories":[{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"44"}]}]},{"title":"Obese (≥30)","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"85"}]}]}]},{"title":"Oxygen saturation","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"percentage of oxygen saturation","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"97","lowerLimit":"96","upperLimit":"98"},{"groupId":"BG001","value":"97","lowerLimit":"96","upperLimit":"98"},{"groupId":"BG002","value":"97","lowerLimit":"96","upperLimit":"98"}]}]}]},{"title":"Most severe COVID 19 symptom at baseline","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Loss of sense of smell","categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"44"}]}]},{"title":"Fatigue","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"35"}]}]},{"title":"Body aches","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"22"}]}]},{"title":"Cough","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"10"}]}]},{"title":"Subjective fever","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"12"}]}]},{"title":"Loss of appetite","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"11"}]}]},{"title":"Chills","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"9"}]}]},{"title":"Shortness of breath","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]}]},{"title":"Loss of taste","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]},{"title":"Nausea","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Who Met Clinical Worsening","description":"Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (\\<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation \\>92%.","populationDescription":"The primary and secondary end points were measured using participants' self-reported responses on twice-daily surveys during the 15 days after randomization that were corroborated by research staff with phone contact.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"RCT (approximately 15 days)","groups":[{"id":"OG000","title":"Fluvoxamine","description":"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.\n\nFluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."},{"id":"OG001","title":"Placebo","description":"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.\n\nPlacebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"72"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"6"}]}]}]},{"type":"SECONDARY","title":"Clinical Deterioration on a Likert-type Scale (0-6)","description":"(0) none; (1) moderate severity of illness as defined by O2 saturation \\<92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation \\<92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.","populationDescription":"The primary and secondary end points were measured using participants' self-reported responses on twice-daily surveys during the 15 days after randomization that were corroborated by research staff with phone contact.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"RCT (approximately 15 days)","groups":[{"id":"OG000","title":"Fluvoxamine","description":"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.\n\nFluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated."},{"id":"OG001","title":"Placebo","description":"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.\n\nPlacebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"72"}]}],"classes":[{"categories":[{"title":"0 (none)","measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"66"}]},{"title":"1, shortness of breath and oxygen saturation less than 92% but no supplemental oxygen needed","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]},{"title":"2, O2 saturation plus supplemental oxygen requirement","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"3, oxygen saturation less than 92% + supplemental O2 and hospitalized related to dyspnea or hypoxia","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]},{"title":"4, the above, plus ventilator support requirement;","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]},{"title":"5, oxygen < 92%, + supplemental O2, hospitalized related to dyspnea/hypoxia + ventilator 3 days","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]},{"title":"6, Death","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Adverse event data were collected daily via participant self-report during the 15 day RCT and again at the 30 day follow-up for both the fluvoxamine and placebo groups.","eventGroups":[{"id":"EG000","title":"Fluvoxamine","description":"Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.\n\nFluvoxamine: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.","deathsNumAffected":0,"deathsNumAtRisk":80,"seriousNumAffected":1,"seriousNumAtRisk":80,"otherNumAffected":13,"otherNumAtRisk":80},{"id":"EG001","title":"Placebo","description":"Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.\n\nPlacebo: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.","deathsNumAffected":0,"deathsNumAtRisk":72,"seriousNumAffected":6,"seriousNumAtRisk":72,"otherNumAffected":28,"otherNumAtRisk":72}],"seriousEvents":[{"term":"Dehydration","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":80},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Exacerbation of COVID 19 with hospitalization","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Hospitalized for nausea, vomiting, and chest pain (O2 not below 92%)","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Flank Pain (hospitalized)","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Exacerbation of COVID 19 with hospitalization","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Hospitalized for nausea, vomiting, fever, low oxygen saturation, and pneumonia","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Acute chronic respiratory failure with hypoxia and hypercapnia (hospitalized)","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Bilateral multi-focal pneumonia with shortness of breath and low oxygen saturation (hospitalized)","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Exacerbation of COVID 19 with hospitalization","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Hospitalized with nausea, fever, and pneumonia with requirement of supplemental oxygen to maintain oxygen saturation about 92%","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72}]}],"otherEvents":[{"term":"Pneumonia","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":80},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":72}]},{"term":"Shortness of breath","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":80},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":72}]},{"term":"Headache or head pain","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":72}]},{"term":"Gastroenteritis, nausea, or vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":80},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":72}]},{"term":"Muscle aches","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":80},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Bacterial infection","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":80},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Vasovagal syncope","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":80},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Teeth chattering","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":80},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":72}]},{"term":"Dehydration","organSystem":"General 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