Créditos: Comité científico CovidLeer más
Fluvoxamine — a selective serotonin reuptake inhibitor prescribed for various mental health disorders — has been proposed as a treatment for COVID-19, in part because of its putative anti-inflammatory effect. Observational data and a small randomized trial suggested benefit. Now, this drug has been tested in a placebo-controlled, adaptive platform trial enrolling high-risk outpatients with COVID-19 in Brazil.
Some 1500 participants with <7 days of symptoms and a known risk factor for severe COVID-19 were assigned 1:1 to receive fluvoxamine or placebo for 10 days. The primary outcome — a composite of observation in a COVID-19 emergency setting for >6 hours or transfer to a tertiary hospital — occurred in 11% of the fluvoxamine group and l6% of the placebo group (relative risk, 0.68). Rates of hospitalization were 10% (fluvoxamine) and 13% (placebo), this difference was not statistically significant. Time to hospitalization, duration of hospitalization, number requiring mechanical ventilation, and deaths were not significantly different between groups.
When this trial was being conducted, many hospitals in Brazil were above capacity; thus, the authors argue that observation in an emergency setting for >6 hours is a reasonable surrogate for hospitalization. However, other trials, including a study of anti–SARS-CoV-2 monoclonal antibodies (NEJM JW Infect Dis Dec 2021 and N Engl J Med 2021 Jul 14; [e-pub]), have used different thresholds to assess efficacy of outpatient therapies, such as COVID-19–related hospitalization (acute care for ≥24 hours) or death. At this point, it’s difficult to be certain how the benefits of fluvoxamine compare with those of anti–SARS-CoV-2 monoclonal antibodies, which have become standard of care in the U.S. for high-risk, nonhospitalized patients with mild or moderate COVID-19. For now, I am continuing to refer such patients for anti–SARS-CoV-2 monoclonal antibodies while eagerly awaiting results of additional trials evaluating fluvoxamine (e.g., ACTIV-6). Oral anti–SARS-CoV-2 antivirals, such as molnupiravir and a viral protease inhibitor, are also advancing rapidly and may soon transform the management of early COVID-19.
Créditos: Comité científico Covid