(Sharecast News) - Swiss pharmaceutical group Novartis said on Monday that it has reached an agreement with the US Food and Drug Administration to conduct a Phase III clinical trial with around 440 patients to evaluate the use of malaria drug hydroxychloroquine in the treatment of patients hospitalised with Covid-19.
The trial will be conducted at more than a dozen sites in the US. Novartis plans to begin enrolment for the study within the next few weeks and will report results "as soon as possible".
"We recognise 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 Novartis. "We mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study."
There are currently no approved treatments for the coronavirus, but clinicians are evaluating drugs that have been approved for other diseases, hoping that these will also work against Covid-19, Novartis said.
Patients in the trial will be randomised into three groups. The first will receive hydroxychloroquine, while the second group will receive hydroxychloroquine and antibiotic therapy azithromycin. The third group will be given a placebo.