The National Institutes of Health (NIH) said on Thursday it began a study to evaluate the combination of the antibiotic azithromycin and the malaria drug hydroxychloroquine, previously touted as a “ game changer ” for treating COVID-19 .
The mid-stage study, for which Teva Pharmaceutical Industries Ltd will be donating drugs, will assess whether the combination may prevent hospitalization and death from COVID-19, the respiratory disease caused by the coronavirus.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, sponsors the trial, which is run by the NIAID-funded AIDS Clinical Trials Group (ACTG).
“While 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 may improve clinical outcomes.” NIAID director Anthony Fauci said on Thursday.
The announcement comes after the U.S. Department of Health and Human Services replaced Rick Bright last month as director of a major U.S. agency tasked with developing drugs and vaccines for COVID-19.
Bright had said he had been dismissed as director of the Biomedical Advanced Research and Development Authority, or BARDA, because he opposed attempts to push hydroxychloroquine and chloroquine to treat COVID-19 because their effectiveness had not been demonstrated.
The NIH’s latest study will enroll approximately 2,000 adults in clinical locations across the country, many of whom are expected to be 60 years of age or older or who have a co-morbidity associated with developing serious complications from COVID-19, such as a heart – vascular disease or diabetes.
The U.S. Food and Drug Administration had warned last month about the use of the malaria drugs, hydroxychloroquine and chloroquine, in COVID-19 patients because of the risk of serious cardiac arrhythmias.