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.

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.

Researchers 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%), with a likelihood of superiority of 99.8%. This exceeded the prespecified superiority threshold of 97.6%, 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, according to researchers. The treatment effect was larger in a per-protocol analysis, which included patients “with a high level of adherence”, 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. In the per-protocol population, one death occurred in the fluvoxamine cohort and 12 deaths occurred in the placebo cohort. 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,” researchers said in the release.

Source: https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext
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