The National Institutes of Health (NIH) has started a clinical trial to evaluate whether a drug combination promoted by President Trump as a potential COVID-19 treatment is effective.
The trial will study the use of hydroxychloroquine, a malaria drug, and azithromycin, an antibiotic, in 2,000 adult COVID-19 patients.
“We urgently need a safe and effective treatment for COVID-19. Repurposing existing drugs is an attractive option because these medications have undergone extensive testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
“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,” he added.
The goal of the study is to determine whether the drug combination can prevent hospitalization and death from COVID-19.
The use of hydroxychloroquine and azithromycin to treat COVID-19 has been heavily, and controversially, promoted by President Trump.
Rick Bright, the former director of the Biomedical Advanced Research and Development Authority, told members of Congress on Thursday that he was removed from his post by Trump officials because he resisted pressure to make hydroxychloroquine more widely available in the U.S. as a COVID-19 treatment before it was studied in clinical trials.
“There were some attempts to bypass that rigorous vetting process that caused me great concern,” Bright told members of the House Energy and Commerce subcommittee on health.
Several Republicans on the committee questioned Bright about his concern with hydroxychloroquine, pointing to anecdotal evidence that suggests the drug could be an effective COVID-19 treatment.
“Doctors across the country will use drugs off label in a circumstance where they don’t see a viable alternative to that,” noted Rep. Larry Bucshon (R-Ind.), a doctor.
However, a panel of doctors and experts convened by the NIH has advised against combining hydroxychloroquine and azithromycin outside of clinical trials, warning of potentially harmful effects, including heart problems.
The NIH clinical trial will evaluate the safety of the experimental treatment for COVID-19 infection. While the drugs are considered safe in most people, the NIH notes, some experience side effects like headache and nausea and in rare cases life-threatening heart rhythm problems.