Novartis announced Monday that it reached an agreement with the FDA to begin a Phase III study evaluating the use of hydroxychloroquine for the treatment of hospitalised patients with COVID-19 disease. The trial, which will be conducted in the US, will start recruitment within the next few weeks and aims to enrol around 440 patients.
"We recognise the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease," remarked John Tsai, head of global drug development at Novartis, adding "we mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study."
In the trial, patients will be randomised to receive hydroxychloroquine, the antimalarial drug in combination with the antibiotic azithromycin or placebo. Novartis said that if the study is successful and hydroxychloroquine is approved for COVID-19, the company will make intellectual property within its control as it relates to use of the drug to treat or prevent the disease available through non-exclusive voluntary licenses, appropriate waivers or similar mechanisms to support broad access.
Last month, Novartis agreed to donate up to 130 million doses of hydroxychloroquine as part of global efforts exploring use of the medicine to treat patients with COVID-19 infection. The company has so far donated 30 million tablets to the US Department of Health and Human Services, with the FDA issuing an emergency-use authorisation to the Biomedical Advanced Research and Development Authority allowing the drug to be used to treat hospitalised adults and adolescents with COVID-19, when a clinical trial is not available or feasible. The donation came amid comments from US President Donald Trump suggesting that another antimalarial drug, chloroquine, would be made available by prescription "almost immediately" to treat patients with COVID-19 infection.
Meanwhile, earlier this month, Novartis and partner Incyte announced that they plan to initiate a Phase III collaborative study to assess the JAK1/JAK2 inhibitor ruxolitinib plus standard-of-care, versus standard care alone, in patients suffering from COVID-19-associated cytokine storm. The Swiss drugmaker also plans to investigate the anti-IL-1 beta monoclonal antibody Ilaris (canakinumab) for hospitalised patients with COVID-19 infections.
For related analysis, listen to our latest podcast from FirstWord executive editors Simon King and Michael Flanagan, which includes a discussion of further potential treatment options and the politicisation of different approaches in the absence of meaningful data from controlled clinical studies.
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