by Paul Govern
Vanderbilt University Medical Center has joined a nationwide study to evaluate repurposed medications in the search for effective, safe treatments for mild-to-moderate COVID-19. Repurposed medications are those already approved by the U.S. Food and Drug Administration for other indications.
ACTIV-6, “The Randomized Trial to Evaluate Efficacy of Repurposed Medications,” is a placebo-controled, double-blind study expected to enroll nearly 15,000 participants from across the U.S. through its website (activ6study.org) and call center, 833-385-1880.
Parul Goyal, MBBS, assistant professor of Clinical Medicine, is the principal investigator for the research site at VUMC.
“We continue to seek outpatient treatments for COVID that can help prevent worsening of symptoms and reduce the need for hospitalization,” Goyal said. “There currently are no prescription medications that carry an indication for mild-to-moderate COVID, but we have some promising candidate drugs already at market, with established safety profiles. We are very pleased to be taking part in this important research project and we urge all would-be participants to take advantage of the study’s easy online screening process.”
The study is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), led by the National Center for Advancing Translational Sciences. The NIH has provided an initial investment of $155 million in funding for the repurposed drug trial.
As previously reported, VUMC also serves as the national Data Coordinating Center for ACTIV-6. The principal investigator for the center is Chris Lindsell, PhD, professor of Biostatistics and director of the Research Methods Program at the Vanderbilt Institute for Clinical and Translational Research. Co-investigators for the center include Sean Collins, MD, MSci, Wesley Self, MD, MPH, Russell Rothman, MD, MPP, Thomas Stewart, PhD, MS, and Frank Harrell PhD. The Duke Clinical Research Institute, part of Duke University, in Durham, North Carolina, is the Clinical Coordinating Center for the ACTIV-6 platform.
Participants will be randomized to study drugs or placebo and will self-report any new or worsening symptoms or medical events they may experience while taking the study drug or placebo. Study visits are intended to be all remote, with no in person visits. The study is now testing three repurposed medications:
- Invermectin, used to treat parasitic infections;
- Fluticasone, an inhaled steroid commonly prescribed for asthma and chronic obstructive pulmonary disease; and
- Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), often prescribed for depression.
To be eligible, participants must be 30 years old or older, have had a positive COVID-19 test within the past 10 days, and have at least two symptoms of the illness for seven days or less. Symptoms include fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, and new loss of sense of taste or smell.
For more information or to enroll, visit activ6study.org. The study is funded by the National Institutes of Health (TR001608).
