Table 1.

Key characteristics of completed studies on fluvoxamine for treatment of SARS-CoV-2 infection

Study, first author [references]	Design	Sample size	Intervention	Study population and inclusion criteria		Duration		Findings
Lenze [1]	Randomized controlled trial (participants were randomized 1:1 to a fluvoxamine arm or a placebo arm)	152	Fluvoxamine 100 mg, 3x/day × 14 days	Aged ≥ 18, not hospitalized or living in an institutional setting, diagnosed, symptomatic SARS-CoV-2 infection < 7 days from symptoms onset		15 days		Zero (0%) of the participants receiving fluvoxamine met the criteria for clinical deterioration (dyspnea and hypoxia) within 15 days, but 6 (8.3%) of the participants receiving placebo deteriorated clinically (absolute difference of 8.7%, 95% CI 1.8 to 16.4%)
Seftel [19]	Observational cohort (participants were given a free choice of fluvoxamine treatment same day as diagnosis, or observation only)	113	Fluvoxamine 50–100 mg load, then 50 mg 2x/day × 14 days	Workers with a congregate living environment during a mass outbreak of COVID-19; patients tested positive for SARS-CoV-2 during mass testing		14 days		65 people opted into fluvoxamine treatment; at 14 days, 0% (0/65) of those receiving fluvoxamine had been hospitalized for clinical deterioration, and 12.5% (6/48) of those declining treatment had been hospitalized (p = 0.005). By Day 14, 0% (0/65) of those in the fluvoxamine group reported ongoing symptoms related to COVID-19, whereas 60% (29/48) of those receiving no treatment reported symptoms (p < 0.001), with 21% (10/48) reporting ≥ 5 ongoing symptoms at 14 days
Reis [21]	Phase III: quadruple-blind randomized controlled trial (participants randomized 1:1:1:1 to treatment with fluvoxamine, metformin HCL, ivermectin, or placebo)	3323	Fluvoxamine 100 mg, 2x day × 10 days	Brazil. Aged > 18, positive SARS-CoV-2 test, acute flu-like symptoms for < 7 days, and at least one of the following: aged > 50, diabetes mellitus requiring oral medication or insulin, systemic arterial hypertension requiring at least one medication for control, known cardiovascular disease (e.g. heart failure, congenital heart disease, cardiomyopathies), symptomatic lung disease (emphysema or chronic bronchitis), symptomatic asthma requiring chronic use of agents for symptoms control, smoking, body mass index > 30 kg/m2 body weight, organ transplant, stage IV chronic kidney disease or need for dialysis, immunosuppression or receiving corticosteroid therapy equivalent to ≥ 10 mg of prednisone/day, history of cancer in the last 5 years or currently undergoing cancer treatment, or SARS-CoV-2 vaccination	28 days		Primary endpoints were: (1) rate of emergency visits with observation unit stay > 6 h, and (2) rate of hospitalization due to lower respiratory tract infection related to COVID-19 Secondary endpoints included: (1) change in viral load on Days 3 and 7 after randomization, (2) time to clinical improvement (self-reported improvement > 50% compared to baseline symptoms), (3) time to hospitalization due to progression of COVID-19, (4) number of days with respiratory symptoms since randomization, (5) rate of all-cause hospitalizations, (6) rate of COVID-19-related hospitalizations, (7) rate of all-cause mortality, (8) rate of cardiovascular death, (9) rate of respiratory death, (10) rating on the PROMIS Global-10 Scale [28], (11) rating on the WHO Clinical Progression Scale [29], (12) rate of adverse events, and (13) percent adherence to study drug