As a growing number of studies raise alarms about using hydroxychloroquine to treat COVID-19, the National Institutes of Health (NIH) is starting a large clinical trial to evaluate the drug in combination with the antibiotic azithromycin.
The NIH’s National Institutes for Allergy and Infectious Diseases will conduct the phase 2b trial to examine whether the combination can prevent hospitalization and death in mild to moderate cases of COVID-19.
The trial will enroll approximately 2,000 patients across the U.S. who experience fever, cough and/or shortness of breath. Participants will be randomized to receive either hydroxychloroquine and azithromycin or placebos to take at home.
Teva Pharmaceuticals is donating both medicines for the study. Results of the trial are expected later this year.
Last month, an expert panel of the NIH recommended against the use of the combination outside of clinical trials for COVID-19 because of the potential toxicity and an increased risk of heart problems (DID, April 23).
Since then, the FDA and European Medicines Agency have warned of heart problems associated with using chloroquine or hydroxychloroquine with or without azithromycin (DID, April 27).
Other trials have cast doubt on the use of hydroxychloroquine either alone or with azithromycin for treatment of COVID-19. The largest study of hydroxychloroquine to date found that patients taking hydroxychloroquine and azithromycin were more than twice as likely to experience cardiac arrest than those who took hydroxychloroquine alone (DID, May 13).
A separate study of nearly 1,400 patients found that patients receiving hydroxychloroquine were just as likely to develop respiratory failure leading to intubation or death as those not taking the drug (DID, May 8). — Jordan Williams