One of the treatments touted by President Donald Trump for COVID-19, a combination of the antimalarial drug hydroxychloroquine and the antiviral drug azithromycin, is the subject of a nationwide study with UW Medicine playing a role.
The Phase 2b clinical trial, sponsored by the National Institute of Allergy and Infectious Disease at the National Institutes of Health, will involve 2,000 outpatients who have tested positive for COVID-19 and are in the early stages of treatment.
"We know from a number of different other kinds of infections that if antiviral treatment is going to be effective, it tends to be most effective if it's given very early on," Ann Collier, a professor at the University of Washington's School of Medicine, said in a video about the study.
The two drugs have been the subject of other studies — including a complementary 630-patient trial in which UW Medicine is also involved. That smaller trial is designed to focus on the effect of the drugs on viral shedding, while the larger trial will focus on clinical outcomes.
Hydroxychloroquine and azithromycin are attractive drug candidates for treating COVID-19 because they've already undergone extensive testing for other medical applications, such as treating malaria and autoimmune diseases such as lupus.
However, the interest shown by Trump in hydroxychloroquine and a similar drug, chloroquine, has led to shortages for patients who need those drugs for other types of treatment. Moreover, the studies conducted to date have raised questions about the drugs' efficacy.
"There have been a number of publications looking at outcomes in hospitalized patients given this treatment," Collier said. "But none of them have been [conducted using] the rigorous study design that is usually used to determine whether treatments are effective."
In addition to UW, 30 other sites across the country associated with the AIDS Clinical Trials Group will be enrolling patients for the randomized, controlled study. Half the participants will receive the drug combination for seven days, while the other half will receive placebos. There'll be six months of follow-up afterward.
Hydroxychloroquine carries a risk of causing heart problems — but Collier said the drug dosage has been adjusted to address the Food and Drug Administration's concerns, and patients will be closely checked for signs of toxicity.
In a news release, NIAID Director Anthony Fauci said the study should provide definitive answers about the drug combination's effects.
"Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes," Fauci said.
The trial is open to outpatients aged 18 or older who have tested positive for COVID-19 and are experiencing symptoms, but have no need for hospitalization. The first dose of study treatment is to be administered within 96 hours of the positive test. Those interested in participating in the trial should email actg.communications@fstrf.org or actu@uw.edu, or call or text 206-773-7129.
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