COVID-19 clinical trials
Fluvoxamine showed promise in a randomized, placebo-controlled trial of 152 COVID-19 positive outpatients. In a paper published in November, 2020 in the Journal of the American Medical Association:
Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P = .009). The fluvoxamine group had 1 serious adverse event and 11 other adverse events, whereas the placebo group had 6 serious adverse events and 12 other adverse events. -JAMA
Overall, 65 persons opted to receive fluvoxamine 50mg twice daily and 48 declined. Incidence of hospitalization was 0% (0/65) with fluvoxamine and 12.5% (6/48) with observation alone. At 14 days, residual symptoms persisted in 0% (0/65) with fluvoxamine and 60% (29/48) with observation.
Trials in progress
- Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients - Randomized, double-blind, placebo-controlled trial in 100 moderate COVID-19 hospitalized patients
- Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2) - An expansion of the smaller contactless (telemedicine) randomized control trial above to 1100 participants. Early treatment, outpatient.
- Fluvoxamine for Adults With Mild to Moderate COVID-19 - Randomized control trial of 400 patients admitted to community treatment centers in South Korea. Mild to moderate symptoms.
- Repurposed Approved Therapies for Outpatient Treatment of Patients With Early-Onset COVID-19 and Mild Symptoms - Parallel assigment, 4-arm randomized control trial that includes a Fluvoxamine arm. Early treatment, outpatient. 2724 participants total across 4 arms.
Mechanism of possible benefit?
Mechanisms of potential benefit in COVID-19 may include sigma-1 receptor agonism. See "Fluvoxamine alleviates ER stress via induction of Sigma-1 receptor" and "Modulation of the sigma-1 receptor–IRE1 pathway is beneficial in preclinical models of inflammation and sepsis".
- "Repurposing of CNS drugs to treat COVID-19 infection: targeting the sigma-1 receptor"
- "Repurposing Sigma-1 Receptor Ligands for COVID-19 Therapy?"
As an antidepressant
An observational study of 7,345 hospitalized COVID-19 patients hinted at possible benefit of prior antidepressant usage.
As an anti-viral
In an October, 2020 preprint, fluoxetine, a related SSRI, showed in vitro anti-SARS-CoV-2 activity in Vero and Calu-3 cells.
- Wired - How a Medication for OCD Ended Up in a Covid-19 Trial
- ScienceNews - The antidepressant fluvoxamine could keep mild COVID-19 from worsening
- Washington Post - Existing drugs could help treat covid-19. How do we know when to use them?
Notes on side effects & interactions
- "What we know about fluvoxamine for COVID-19 and how to prescribe. Providers thinking about using fluvoxamine will find this information helpful. " - Dr. Eric Lenze, one of the researchers who is running the fluvoxamine trials (above).