Novartis has reached a deal with the Food and Drug Administration to proceed with a clinical trial on the efficacy of hydroxychloroquine, a malaria drug, in treating hospitalized COVID-19 patients, the Swiss drug company announced on Monday.
The trial of about 440 patients is supposed to be conducted at more than a dozen sites across the U.S.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, head of global drug development and chief medical officer at the company.
The FDA has issued emergency-use authorization to allow doctors to administer the drug to COVID-19 patients under certain conditions, though there is no official FDA-approved product available to treat the coronavirus.
President Trump has repeatedly touted hydroxychloroquine as a potential “game-changer” in the battle against the new coronavirus. A recent international poll of more than 6,200 doctors found that it was the most effective therapy for COVID-19 out of a list of more than a dozen options.
But some health experts have cautioned against jumping to conclusions and have warned of potential side effects. A recent study in Brazil on chloroquine, a similar drug, had to be stopped early in one group of patients after some had developed heart rhythm problems.