Fluvoxamine as a potential treatment for COVID-19

Feb 17, 2021

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*Since recording this podcast in January 2021, Steve Kirsch has publicly made misleading allegations regarding vaccine effectiveness and safety (e.g., Kirsch has claimed that mRNA vaccines are ineffective and are responsible for large numbers of deaths). While ExMedPod believes diverse viewpoints ought to be publicly discussed, we do not endorse Kirsch's beliefs regarding vaccine safety and efficacy.*

[Update: August 2022 - A RCT published in the NEJM tested the efficacy of fluvoxamine and did not find a reduction in emergency department visits, hospitalizations, or deaths associated with Covid-19.]

In this episode recorded in January 2021, we interview Steve Kirsch, the executive director of the COVID-19 Early Treatment Fund. We discuss why the antidepressant Fluvoxamine is being investigated as a potential treatment for COVID-19. We explore the observational and clinical data supporting its efficacy and examine the limitations of these studies. We briefly touch on why physicians and regulatory agencies have not embraced this medication despite some convincing real-world evidence on its clinical efficacy.

What is Fluvoxamine?

Fluvoxamine (Luvox) is a Selective Serotonin Receptor Inhibitor (SSRI) that is clinically indicated for OCD in children, and can be used off label for depression. It was approved by the FDA in 1994 and has been used in millions of patients worldwide. Side effects include nausea, upset stomach (up to 25%), and other sexual side effects typical of SSRIs.

Clinical Data:

Eric Lenze’s Phase 2 RCT on Fluvoxamine vs Placebo (Nov 2020)

Results: “Of 152 patients who were randomized (mean [SD] age, 46 [13] years; 109 [72%] women), 115 (76%) completed the trial. 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.”

David Seftel's Open Label Clinical Trial of Fluvoxamine (Jan 2021)

Abstract: “We report a real-world experience using fluvoxamine for coronavirus disease 19 (COVID-19) in a prospective cohort in the setting of a mass outbreak. 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.”

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