Fluvoxamine shows promise in patients with COVID-19
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The antidepressant fluvoxamine reduced the need for hospitalization among high-risk patients with COVID-19, according to results of the randomized, placebo-controlled TOGETHER trial.
“[Fluvoxamine] could be one of our most powerful weapons against the virus and its effectiveness is one of the most important discoveries we have made since the pandemic began,” Edward Mills, PhD, FRCP, a co-principal investigator for the TOGETHER trial and a professor in the department of health research methods, evidence and impact at McMaster University in Canada, said in a press release.
![The quote is: “[Fluvoxamine] could be one of our most powerful weapons against the virus and its effectiveness is one of the most important discoveries we have made since the pandemic began." The source of the quote is Edward Mills, PhD, FRCP.](/~/media/slack-news/fm_im/misc/infographics/2021/october/pc1021reis_graphic_01_web.jpg?w=800)
According to the FDA, fluvoxamine is a selective serotonin reuptake inhibitor that is indicated for obsessive compulsive disorder, anxiety and depression. The press release said fluvoxamine costs about $4 for a 10-day regimen and could “be a game-changer for poorer countries with low vaccination rates and lacking access to more advanced COVID-19 therapies.”
Mills and colleagues analyzed data on patients (average age, 50 years; 58% women) in Brazil who were randomly assigned between Jan. 15 and Aug. 6 to receive 100 mg of fluvoxamine twice daily (n = 741) or placebo (n = 756) for 10 days. All the patients were “confirmed positive for SARS-CoV-2” and had a risk factor for severe COVID-19, with type 2 diabetes and uncontrolled hypertension being the most common risk factors.
The findings, published in The Lancet Global Health, showed that the proportion of patients seen in a COVID-19 emergency setting longer than 6 hours or transferred to a tertiary hospital for COVID-19-related reasons within 28 days of randomization was lower in the fluvoxamine cohort than the placebo cohort (11% vs. 16%; RR = 0.68; 95% Bayesian Credible Interval [BCI], 0.52-0.88), with a likelihood of superiority of 99.8%. This exceeded the prespecified superiority threshold of 97.6% (risk difference = 5%), according to the researchers.
The results closely aligned with those of a modified intention-to-treat analysis, which was limited to patients who received at least 24 hours of treatment before a primary outcome event (RR = 0.69; 95% BCI, 0.53-0.9), according to Mills and colleagues. The treatment effect was larger in a per-protocol analysis, which included patients “with a high level of adherence” (RR = 0.34; 95% BCI, 0.21-0.54), the researchers wrote.
In the primary intention-to-treat analysis, 17 patients died in the fluvoxamine cohort and 25 patients died in the placebo cohort (OR = 0.68; 95% CI, 0.36-1.27). In the per-protocol population, one death occurred in the fluvoxamine cohort and 12 deaths occurred in the placebo cohort (OR = 0.09; 95% CI, 0.01-0.47). There were 84 patients who stopped taking fluvoxamine and 64 patients who stopped taking placebo during the trial due to tolerability concerns. The researchers found no significant differences in adverse events between the two cohorts.
“Fluvoxamine is, so far, the only treatment that if administered early, can prevent COVID-19 from becoming a life-threatening illness,” Mills said in the release.
References
An old drug saves the lives of COVID-19 patients. https://www.eurekalert.org/news-releases/932847. Published Oct. 27, 2021. Accessed Oct. 28, 2021.
FDA. Fluvoxamine Maleate Information. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fluvoxamine-maleate-information. Accessed Oct. 28, 2021.
Generic Version of Luvox CR Given Final Approval for OCD. Published March 14, 2013. Accessed Oct. 28, 2021. https://www.empr.com/home/news/generics-news/generic-version-of-luvox-cr-given-final-approval-for-ocd/.
Reis G, et al. Lancet Glob Health. 2021;doi:10.1016/S2214-109X(21)00448-4.
Perspective
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The study by Reis and colleagues is at least the second to show a benefit conferred on mild COVID-19 patients with fluvoxamine treatment.
Though it is unclear what the mechanism of action is, there appears to be a real signal that merits more consideration as an inexpensive and readily available oral medication that decreases hospitalization risk significantly would be very welcome as specific antivirals are likely months away. It will be important for the NIH and Infectious Diseases Society of America to assess the evidence and provide recommendations for use.
Perspective
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Eric Lenze, MD
Fluvoxamine’s efficacy against COVID-19 has now been demonstrated in two published placebo-controlled clinical trials, which are considered the gold standard for proof in medicine. The drug is already FDA approved, so doctors can prescribe it off-label now for the treatment of COVID-19. The drug has several advantages: it is safe, well tolerated, easy to use, inexpensive and its safety profile is well understood.
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