The study, which began last summer, is attempting to provide a comprehensive assessment of the controversial treatment. Ivermectin has been celebrated by some as a potential COVID-19 treatment and ridiculed by others who say there’s no proof that the drug works against the coronavirus, and in fact, could be harmful to patients.
“There were some early studies that showed that it could potentially be helpful with COVID-19, but they were not large enough to be definitive,” Adrian Hernandez, MD, one of the study leaders and a cardiologist at Duke University, told the newspaper.
“So we want to know either way, is it potentially beneficial or not,” he said.
Ivermectin is typically used to kill parasites in animals, including heartworm in dogs and gastrointestinal worms in horses and cows. Since the late 1980s, the drug has been used in humans to treat parasitic infections and other illnesses.
However, it’s not approved to treat COVID-19, and the FDA has warned that using the drug, especially formulations made for animals, can be dangerous. The FDA has received multiple reports of people who needed medical attention and hospitalization after taking ivermectin meant for livestock.
At the same time, people have been trying the drug in hopes that it will treat COVID-19. That’s why it’s important to answer the major questions around it, Hernandez said.
“We should understand if there are any benefits,” he told the newspaper. “And if not, we should be able to report that back out to the public clearly and note what shouldn’t be done.”
The Duke study is testing three drugs under ACTIV-6, which is one of a series of studies of potential COVID-19 treatments and vaccines launched by the National Institutes of Health. The goal is to find treatments and vaccines that could make COVID-19 as manageable as the seasonal flu.
The two other drugs in the study are fluvoxamine, a medicine often prescribed for depression and obsessive-compulsive disorder, and fluticasone furoate, a steroid medication prescribed through an inhaler for asthma and chronic obstructive pulmonary disease (COPD).
All three drugs are approved for use in humans, are proven to be safe, and are easy to use at home, the newspaper reported. They also rarely interact with other medications, which could make them good options to treat mild to moderate cases of COVID-19.
“Just like we’re trying to do testing at home, we’re looking at how can you conveniently do treatment at home,” Hernandez said.
About 2,500 people from across the U.S. have taken part in the ACTIV-6 study so far. To qualify, study participants must be 30 or older, have tested positive for the coronavirus within the previous 10 days, and have at least two symptoms. They receive an overnight package with one of the drugs or a placebo, and report how they’re feeling each day by phone or online.
Researchers at Duke are looking for evidence that the drugs either shorten the time that people feel sick or prevent them from getting worse and needing hospitalization, the newspaper reported.
With the recent surge in new COVID-19 cases due to the Omicron variant, enrollment in the study has picked up in recent weeks, the newspaper reported. Hernandez said the study team may have enough data to release initial results within in a month or so.
More information is available on the ACTIV-6 study website.