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The study, led by Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University, found no symptom improvement in those taking the antidepressant at a dose of 100 milligrams (mg) twice daily for 13 days compared to those taking a placebo.
“There was no evidence of improvement in the rate of sustained recovery in participants who took this dose of fluvoxamine versus those who took a placebo,” said researcher Dr. Adrian Hernandez, executive director of the Durham, N.C.-based institute.
Researchers studied fluvoxamine because previous evidence suggested that it might be able to reduce inflammation caused by the virus.
After finding no benefit in taking 50 mg of fluvoxamine twice daily for 10 days, the team tested the higher dose, given that it had a favorable safety profile and efficacy in other studies.
"We are testing repurposed drugs to understand if they are effective in treating COVID-19,” explained Dr. Susanna Naggie, the DCRI principal investigator overseeing the study's clinical coordinating center. The repurposed medications in this study are already approved by the U.S. Food and Drug Administration to treat other conditions.
Fluvoxamine is one of four FDA-approved repurposed medications being tested in the new trial. It's a selective serotonin reuptake inhibitor (SSRI) used to treat obsessive-compulsive disorder and depression.
The findings appear on medRxiv, a pre-publication server. They have been submitted to a peer-reviewed journal. Findings are considered preliminary until published in a peer-reviewed journal.
The clinical trial received funding from the National Institutes of Health.
SOURCE: Duke Clinical Research Institute, news release, Sept. 14, 2023
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