Richard Stradling
Thu, January 20, 2022
Doctors at Duke University are leading a national study to test whether three drugs will effectively treat COVID-19, including one that has generated controversy for more than a year.
Ivermectin’s potential to treat COVID-19 has been both celebrated and ridiculed. Some consider it a miracle drug that makes vaccination against the coronavirus unnecessary. But most in the medical establishment, including government regulators, say there’s not enough proof that it works and warn that self-medicating with ivermectin can make people sick in other ways.
The Duke study, launched last summer, is the kind of comprehensive assessment of ivermectin’s ability to combat COVID-19 that has been missing up to now, said Dr. Adrian Hernandez, one of the study’s leaders.
“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,” Hernandez said in an interview. “So we want to know either way, is it potentially beneficial or not.”
Hernandez said it’s especially important to answer that question because so many people, including some doctors, are trying ivermectin despite warnings against it.
“We should understand if there are any benefits,” he said. “And if not, we should be able to report that back out to the public clearly and note what shouldn’t be done.”
Ivermectin is used to kill parasites in animals, including heartworm in dogs and gastrointestinal worms in horses and cows. Since the late 1980s, it’s also been used with millions of humans to kill parasites that cause river blindness and other illnesses.
Ivermectin is not approved to treat COVID-19, and the U.S. Food and Drug Administration warns that using the drug, especially the kind formulated for animals, can be dangerous. The FDA says it has received multiple reports of people who needed medical attention, including hospitalization, after taking ivermectin intended for livestock.
Three drugs involved in NIH-sponsored study
Ivermectin is one of three drugs that Duke is testing under ACTIV-6, one of a series of studies of potential COVID-19 treatments and vaccines launched by the National Institutes of Health. Duke was chosen for the study because of its experience leading national clinical trials, said Hernandez, a cardiologist who has led large-scale trials.
The goal is to find treatments that, in conjunction with vaccines, might render COVID-19 as manageable as seasonal flu.
Up to now, doctors have mostly relied on monoclonal antibody treatments to try to keep COVID-19 patients from becoming seriously ill. But those must be administered by IV or a series of shots in a clinic or doctor’s office, making them harder to get to patients. In addition, only one of the monoclonals appears to be effective against the omicron variant of the virus, and that drug is in short supply.
The two other drugs being tested in the ACTIV-6 study are fluvoxamine, used to treat obsessive-compulsive disorder and depression, and fluticasone furoate, an inhaler medicine prescribed for asthma and chronic obstructive pulmonary disease or COPD.
All three drugs are already approved for use in humans and have a track record of being safe, Hernandez said. All three are also easy to use at home and rarely interact with other medications, making them candidates 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. “ACTIV-6 is really designed to do that.”
The three drugs were chosen for the study because they’ve shown some promise in treating COVID-19, through earlier studies and by what’s known about how they work in the body. Fluticasone, for example, is a steroid that reduces inflammation in the lungs that can cause breathing problems, which is also a primary symptom of COVID-19.
Earlier studies of ivermectin suggest it decreases reproduction of the coronavirus in the lab, but data from its use in humans was either inconclusive or incomplete.
Nearly 2,500 patients from across the country have taken part in the ACTIV-6 study. Some are referred by doctors at participating medical centers in 26 states, Hernandez said, while others learn about it online.
To qualify, study participants must have tested positive for the coronavirus within the previous 10 days and have at least two symptoms of COVID-19. They receive an overnight package with one of the drugs or a placebo (they can’t tell which), and report how they’re feeling each day by phone or online.
Researchers are looking for evidence that the drugs either shorten the time people feel sick or prevent them from getting worse and needing to be hospitalized.
Enrollment in ACTIV-6 picked up in recent weeks as the wave of new cases fueled by the omicron variant swept the country. Hernandez said researchers may have the data they need to release their results within a month or so.
For information about the ACTIV-6 study, go to activ6study.org/.
Dr. Adrian Hernandez of Duke University Medical School
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