Study to evaluate efficacy of higher dose of ivermectin for treating mild-to-moderate COVID-19

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, M.D., 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 study website, https://activ6study.org, 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, M.D., 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.