Web and phone-based enrollment allows people to help test potential COVID-19 treatments without leaving home.
A study led by the Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University has expanded its testing platform to evaluate ivermectin at a higher dose for a longer period of time.
The drug is one of the three repurposed medications being tested in a study called ACTIV-6, which is enrolling people with mild-to-moderate COVID-19. Repurposed medications are those already approved by the FDA for other medical indications.
“Data from modeling studies, published clinical research, and community interest support investigating multiple doses and durations of ivermectin,” said Adrian Hernandez, MD, MHS, the study’s administrative principal investigator and executive director of the DCRI. “This expansion will provide valuable data on the role of ivermectin and whether it can help people with mild-to-moderate symptoms of COVID-19 prevent worsening of the disease.”
The dose of the expanded study drug arm is 600 mcg/kg daily for six days. Ivermectin, used to treat parasitic infections, is not approved by the FDA to treat COVID-19 and should only be taken as part of a clinical trial, such as ACTIV-6.
Due to successful enrollment, participation is now closed in the arm testing ivermectin at 400 mcg/kg daily for three days. Currently enrolling treatment arms are listed on the ACTIV-6 website, and additional arms will be added to the ACTIV-6 testing platform in the future.
ACTIV-6 (“The Randomized Trial to Evaluate Efficacy of Repurposed Medications”) is a nationwide double-blind study that has enrolled more than 3,000 participants so far, with plans to enroll nearly 15,000 participants from across the United States.
To be eligible, study 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 no more than seven days. To enroll, prospective participants can express interest in the study by filling out the online survey on the ACTIV-6 website or calling 833-385-1880.
People can participate from anywhere in the United States, and medications are shipped to the participant’s home at no cost. There are no required study clinic visits or procedures. Participation involves taking the medication and keeping track of symptoms over 90 days by completing surveys online or by phone.
“We have treatments for people with mild-to-moderate COVID-19 who are at high risk for hospitalization or death, but they remain in limited supply and each current authorized drug has limitations,” said Susanna Naggie, MD, the DCRI principal investigator overseeing the study’s clinical coordinating center. “As cases surge nationally due to the Omicron variant, straining health systems and medical personnel, we need more medications that can be taken at home to treat symptoms of the virus to help people feel better faster.”
Naggie noted the study will continue to add medications over time. “The medications chosen for study in ACTIV-6 have shown potential for treating COVID-19 in the outpatient setting, but they need to be evaluated in a larger, more rigorous and randomized clinical trial to determine efficacy and safety,” she said.
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.
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. The DCRI also serves as the coordinating center for major clinical research programs, such as the Environmental influences on Child Health Outcomes (ECHO) program, the Antibacterial Resistance Leadership Group (ARLG), the NIH Health Care Systems Research Collaboratory, and the Pediatric Trials Network (PTN).