Trial NCT04342663
Publication Lenze E, JAMA, 2020 (published paper)
Dates: 2020-04-10 to 2020-08-05
Funding: Mixed (Taylor Family Institute for Innovative Psychiatric Treatment at Washington University; COVID-19 Early Treat Fund; Center for Brain Research in Mood Disorders at Washington University; Bantly Foundation; National Inst)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
* / USA Follow-up duration (days): 45 | |
| Inclusion criteria | Adults living in the community with SARS-CoV-2 infection confirmed by polymerase chain reaction assay; Symptomatic within 7 days of the first dose of study medication (fever, cough, myalgia, mild dyspnea, diarrhea, vomiting, anosmia, ageusia, sore throat) |
| Exclusion criteria | Having COVID-19 that required hospitalization or evidence of the primary end point with oxygen saturation less than 92% on room air at the time of randomization; Severe underlying lung disease (eg, chronic obstructive pulmonary disease or required home oxygen, interstitial lung disease, pulmonary hypertension); Decompensated cirrhosis; Congestive heart failure (New York Heart Association class III or IV); Immunocompromised (eg, solid organ transplant recipient or donor, bone marrow transplant recipient, AIDS, or taking immunosuppressant biologic drugs or highdose corticosteroids [>20mg/d of prednisone] |
| Interventions | |
| Treatment
Fluvoxamine 50 mg orally on day 1, then 100 mg two times per day for 2 days, then 100 mg three times per day through day 15. |
|
| Control
Placebo Duration : 15 days | |
| Participants | |
| Randomized 181 participants (n1=92 / n2= 89) | |
| Characteristics of participants N=181 Mean age : NR 43 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Time to clinical worsening [Time Frame: RCT (approximately 15 days)]. 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% | |
| In the report Clinical deterioration: (1) presence of dyspnea (ie, shortness of breath) or hospitalization for shortness of breath or pneumonia and (2) decrease in O2 saturation (<92%) on room air or supplemental O2 requirement to maintain O2 saturation of >= 92% | |
| Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the published article, the trial registry, protocol and supplementary appendices were used in data extraction and assessment of risk of bias. The statistical analysis plan contained in the protocol was minimal. There were no substantive differences between the published article, the trial registry and the protocol in terms of population, procedures, treatments or outcomes. The trial employed a wholly remote, contactless design in which COVID-19 patients in the community were recruited, screened, and followed up daily either online or by telephone. Study materials (treatment or placebo, oxygen saturation monitor, an automated blood pressure monitor, and a thermometer) were delivered to the doorstep. The trial achieved its pre-specified sample size. |