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Newswise — DURHAM, N.C. – A study led by the Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University found no differences in relief of mild-to-moderate COVID-19 symptoms between participants taking ivermectin and participants taking a placebo.
“There was no significant benefit in our primary endpoint of resolution of symptoms in mild-to-moderate COVID-19 illness,” said Adrian Hernandez, M.D., the study’s administrative principal investigator and executive director of the DCRI. “Overall, most people improved their symptoms whether they took ivermectin or not. Given these results, there does not appear to be a role for ivermectin outside of a clinical trial setting, especially considering other available options with proven reduction in hospitalizations and death.”
There was also no difference observed in the number of hospitalizations or emergency room visits. 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 double-blind study that has enrolled more than 4,000 participants. The trial continues to enroll with plans to include nearly 15,000 participants from across the United States.
Ivermectin, a medication used to treat parasitic infections, is one of three repurposed medications currently being tested in ACTIV-6. Repurposed medications are those already approved by the U.S. Food and Drug Administration (FDA) for other medical indications.
The ivermectin arm of the study opened in June 2021 and enrolled 1,537 participants across the United States in eight months. During the study, participants took either a dose of 400 mcg/kg per day of ivermectin or a placebo for three days.
Ivermectin is not approved by the FDA to treat COVID-19 and should only be taken for COVID-19 as part of a clinical trial. ACTIV-6 continues to study a higher dose (600 mcg/kg) and longer duration (six days) of ivermectin to better understand the medication’s impact on time to recovery and hospitalization.
“Given the favorable safety profile and continued public interest in ivermectin, the ACTIV-6 team will continue to study this higher dose to determine whether it will make enough of a difference to be considered for the treatment of mild-to-moderate COVID-19,” said Susanna Naggie, M.D., the DCRI principal investigator overseeing the study’s clinical coordinating center. “We are committed to sharing these study results with participants, the public, and scientific community when they are available.”
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, Christopher Lindsell, Matthew McCarthy, Eugene Passamani, April Remaly, Elizabeth Shenkman, Thomas Stewart, Florence Thicklin, Rhonda Wilder, and Sybil Wilson.
ACTIV-6 (ClinicalTrials.gov identifier NCT04885530) received funding from the National Institutes of Health (3U24TR001608-06S1).
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.