“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 Adrian Hernandez, M.D., M.H.S., the study’s administrative principal investigator and executive director of the DCRI.
Findings appear on medRxiv, a pre-publication server, and have been submitted to a peer-reviewed journal.
ACTIV-6 — “The Randomized Trial to Evaluate Efficacy of Repurposed Medications” — is a nationwide, remote, double-blind study that has enrolled more than 7,000 participants. The trial has enrolled participants from across the United States to evaluate the potential benefits for treating mild-to-moderate COVID-19 with repurposed medications.
In ACTIV-6, researchers looked at the rate of sustained recovery, defined as three days without symptoms. Taking 100 mg of fluvoxamine twice a day did not speed up COVID-19 symptom recovery. There was no difference in relief of symptoms for participants taking fluvoxamine compared to a placebo.
Fluvoxamine was chosen for this study because previous evidence suggested that it may be able to reduce inflammation caused by the virus. The ACTIV-6 team previously tested fluvoxamine 50 mg twice daily for 10 days and found no benefit to taking fluvoxamine for COVID-19 treatment at that dose or duration. Although the lower dose of fluvoxamine was not effective, the medication is safe and well tolerated. Given the favorable safety profile and efficacy found in other studies, the ACTIV-6 team decided to test the medication at a higher dose of 100 mg.
“In ACTIV-6, we are testing repurposed drugs to understand if they are effective in treating COVID-19,” said Susanna Naggie, M.D., M.H.S., the DCRI principal investigator overseeing the study’s clinical coordinating center. “We plan to study at least one more medication in ACTIV-6, and look forward to sharing results with the community as soon as possible.”
Repurposed medications are those already approved by the U.S. Food and Drug Administration (FDA) for other medical indications. Fluvoxamine is one of four FDA-approved repurposed medications being tested in ACTIV-6.
The ACTIV-6 study aims to include participants from diverse backgrounds so that results from the study are applicable to everyone affected by COVID-19. The study has seen an increase in participation and interest from members of the Hispanic community. In this arm of the study, 46 percent of participants identified as Hispanic/Latino, compared to 17 percent in the lower-dose fluvoxamine arm.
“As ACTIV-6 continues to evaluate repurposed drugs for the treatment of mild-to-moderate COVID-19, we strive to reach those communities that are often underrepresented, yet most impacted by the virus,” said Hernandez. “Participation from these communities is essential to ensure that we find results that might help everyone feel better faster.”
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI), which is used to treat obsessive-compulsive disorder and depression. It is not approved by the FDA to treat COVID-19 and should only be taken as prescribed or as part of a clinical trial.
In addition to Drs. Hernandez and Naggie, members of the ACTIV-6 Executive Committee include Stacey Adam, David Boulware, Sean Collins, Allison DeLong, Sarah Dunsmore, G. Michael Felker, George Hanna, Chris Lindsell, Matthew McCarthy, Russell Rothman, Elizabeth Shenkman, Thomas Stewart, Florence Thicklin, and Rhonda Wilder.
ACTIV-6 (ClinicalTrials.gov identifier NCT04885530) received funding from the National Institutes of Health (3U24TR001608-06S1).
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ACTIV-6 is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and is led by the National Center for Advancing Translational Sciences (NCATS). The DCRI serves as the study’s clinical coordinating center, partnering with Vanderbilt University Medical Center as the study’s data coordinating center. The study is leveraging the infrastructure of PCORnet®, the National Patient-Centered Clinical Research Network, supported by the Patient-Centered Outcomes Research Institute, and the Trial Innovation Network, a collaborative initiative within the NCATS Clinical and Translational Science Awards Program that helps address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies.
About the Duke Clinical Research Institute
The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization in the world. Our mission is to develop, share, and implement knowledge that improves global health through innovative clinical research. The institute conducts multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. The DCRI is a pioneer in cardiovascular and pediatric clinical research, and conducts groundbreaking clinical research across multiple other therapeutic areas, including infectious disease, neuroscience, respiratory medicine, and nephrology. The DCRI is also involved with other ACTIV studies, serving as the U.S. coordinating center for ACTIV-1, a COVID-19 master protocol study testing immune modulators, and participating in ACTIV-4, which is examining optimal use of oral anticoagulants to prevent COVID-19-associated blood clots.