[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, Daniel Belkin and Mitch Belkin 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.
Who is Steve Kirsch?
Steve Kirsch is a serial tech entrepreneur and philanthropist. He holds a Bachelor of Science and a Masters of Science in electrical engineering and computer science from MIT. He is currently the CEO of M10 and executive director of the COVID-19 early treatment fund.
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.
Summary
If you are looking for a quick summary of the evidence regarding Fluvoxamine, take a look at Steve Kirsch’s Powerpoint on Fluvoxamine.
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.”
Ongoing Phase 3 Clinical Trial on Fluvoxamine
An addendum from Steve: If you’d like to participate in the ongoing phase 3 study, check out www.stopcovidtrial.com. Enrollment is free and you can participate from the comfort of your own home.