Ivermectin is one of three repurposed medications tested in ACTIV-6, a nationwide double-blind study
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. These results confirm findings from a previous arm of the study that tested a lower dose and shorter duration of ivermectin.
“There was no significant benefit in our primary endpoint of resolution of symptoms in mild-to-moderate COVID-19 illness or any other endpoints,” said Adrian Hernandez, M.D., the study’s administrative principal investigator and executive director of the DCRI. “Given these results, and in conjunction with an earlier arm of the study testing a different dose of ivermectin, there does not appear to be any role for ivermectin in treating mild-to-moderate COVID-19, especially considering other available options with proven reduction in hospitalizations and death.”
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 5,000 participants. The trial continues to enroll with plans to include thousands of participants from across the United States.
Ivermectin, a medication used to treat parasitic infections, is one of three repurposed medications tested in ACTIV-6. Repurposed medications are those already approved by the U.S. Food and Drug Administration (FDA) for other medical indications. 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.
This arm of the study opened in February 2022 and randomized 1,334 participants across the United States in five months. In this arm, participants took either 600 mcg/kg per day of ivermectin or a placebo for six days.
ACTIV-6 previously tested ivermectin 400 mcg/kg per day for three days from June 2021 to February 2022 and found no clinically significant benefit in resolution of symptoms, hospitalizations, or emergency room visits.
“Public interest in ivermectin and its favorable safety profile supported testing it in this study to evaluate the benefits and risks in a rigorous manner,” said Susanna Naggie, M.D., the DCRI principal investigator overseeing the study’s clinical coordinating center. “Through randomized, direct-to-participant trials like ACTIV-6, which are more convenient for participants, we can answer these important questions of public health interest.”
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, 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).
About ACTIV-6
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.