The National Institutes of Health (NIH) said on Thursday it began a study to evaluate the combination of antibiotic azithromycin and malaria drug hydroxychloroquine, which was previously touted by U.S. President Donald Trump as a “game changer”, for the treatment of COVID-19.
The mid-stage study, for which Teva Pharmaceutical Industries Ltd will be donating medicines, will assess whether the combination can prevent hospitalization and death from COVID-19, the respiratory illness caused by the coronavirus.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is sponsoring the trial, which is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG).
“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,” NIAID Director Anthony Fauci said on Thursday.
The announcement comes after the U.S. Department of Health and Human Services had last month replaced Rick Bright as director of a key U.S. agency charged with developing drugs and vaccines for COVID-19.
Bright had said he was ousted as director of the Biomedical Advanced Research and Development Authority, or BARDA, because he resisted efforts to push hydroxychloroquine and chloroquine to treat COVID-19 as their effectiveness had not been demonstrated.
The NIH’s latest study will enroll about 2,000 adults at clinical sites across the country, with many of those expected to be 60 years of age or older or have a comorbidity associated with developing serious complications from COVID-19, such as a cardiovascular disease or diabetes.
The U.S. Food and Drug Administration had last month warned against the use of the malaria drugs, hydroxychloroquine and chloroquine, in COVID-19 patients due to the risk of serious heart rhythm problems.