Novartis launches FDA-approved study involving hydroxychloroquine, azithromycin, COVID-19 patients
Novartis is launching a new clinical trial to assess the effectiveness of treating hospitalized COVID-19 patients with hydroxychloroquine. The FDA has official signed off on the trial, according to a statement from Novartis, and it will include roughly 440 patients.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” John Tsai, head of global drug development and chief medical officer at Novartis, said in the statement. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
One of the biggest stories surrounding the ongoing COVID-19 pandemic has been the potential use of hydroxychloroquine, a decades-old antimalarial drug, to treat patients who have the virus. Early anecdotal evidence suggested the medication may help COVID-19 patients, and President Donald Trump pushed its use several times during media briefings—but a number of headlines in recent weeks have suggested the treatment may not be effective.
The National Institutes of Health (NIH), for example, has said “there are insufficient clinical data to recommend either for or against” such treatment—and it recommended against treating COVID-19 with a combination of hydroxychloroquine and azithromycin. That combination was also the subject of a joint statement from three cardiovascular societies, which recommended against its use to treat COVID-19 if the patient has cardiovascular disease.
In addition, a recent study involving U.S. veterans found that treating the virus with hydroxychloroquine—with or without the addition of azithromycin—leads to an increase in overall mortality.
“These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs,” the study’s authors said at the time.
The team behind this latest clinical trial from Novartis hopes it can provide additional information in this area. Participants will be randomly separated into three groups—one group will receive hydroxychloroquine, one will receive hydroxychloroquine and azithromycin and the final group will receive a simple placebo. Novartis, through Sandoz, has already committed to donating up to 130 million hydroxychloroquine tablets to investigate its potential as a viable treatment option.
“We are donating hydroxychloroquine tablets for COVID-19 patients including for use in this and other clinical trials with the hope that researchers and healthcare workers can quickly and scientifically determine whether hydroxychloroquine can help patients around the world combat this disease,” Richard Saynor, CEO of Sandoz, said in the statement. “We will continue to fulfill orders for existing customers to ensure the medicine remains available to U.S. patients who rely on it for other indicated uses.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.