The three-arm, placebo-controlled, phase III trial will take place at more than a dozen U.S. sites

Novartis received FDA approval to study hydroxychloroquine in a group of 440 patients with Covid-19. The study will be a phase III trial with enrollment starting in the next few weeks at more than a dozen U.S. sites.

The trial will be randomized with three arms — hydroxychloroquine, hydroxychloroquine plus azithromycin, and placebo. All patients will receive standard of care for Covid-19.

“The clinical trial complements a commitment by Novartis, through Sandoz, to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for treatment of Covid-19. Sandoz has already donated 30 million tablets to the U.S. Department of Health and Human Services and is dispatching further shipments to countries based on requests from governments around the world,” the company said in a statement.

President Donald Trump has touted hydroxychloroquine as a treatment for the Covid-19, saying, “I think it’s going to be great… We’re quickly studying this drug,” CNN reported. But Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, downplayed the hype, and, as was also reported by CNN, the institute isn’t sponsoring any studies.

Trump became a fan of the drug after a study was published in France touting its efficacy against Covid-19, but that study of just 20 people was fairly well discredited when Elsevier, the publisher of the journal, expressed concerns over the content, “the ethical approval of the trial, and the process that this paper underwent to be published within International Journal of Antimicrobial Agents,” CNN also reported.

Nonetheless, the FDA did give emergency use authorization for hydroxychloroquine for compassionate use during the pandemic. However, there have been concerns about the drug’s safety, especially after a study of chloroquine was halted due to heart rhythm problems.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 125

Topic ID: 79,125,730,933,125,190,926,192,927,151,928,925,934