Novartis has entered an agreement with the US Food and Drug Administration (FDA) to conduct a Phase III clinical trial of hydroxychloroquine to treat hospitalised patients with Covid-19.
Hydroxychloroquine, which is commonly used to treat malaria and some autoimmune diseases, showed anti-SARS-CoV-2 activity in laboratory tests.
Sponsored by Novartis, the new Phase III trial will assess hydroxychloroquine as a potential Covid-19 therapy in around 440 participants.
The company’s subsidiary, Sandoz, will supply the drug for the study, which will be performed at more than 12 sites in the US. Novartis intends to start patient recruitment in the coming weeks.
Novartis Global Drug Development head and chief medical officer John Tsai said: “We recognise the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with Covid-19 disease.
“We mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study.”
Trial participants will be randomised to receive hydroxychloroquine, hydroxychloroquine plus azithromycin or placebo. All treatment arms will involve standard of care for Covid-19.
Previously, Novartis, through Sandoz, announced plans to donate up to 130 million hydroxychloroquine tablets to meet the needs related to global clinical research in the event the drug is found to be promising in Covid-19 treatment.
Sandoz has so far donated 30 million tablets to the US Department of Health and Human Services and will send additional shipments to other countries based on requests.
In addition, Novartis plans to provide any intellectual property, within its control, of hydroxychloroquine for Covid-19 via non-exclusive voluntary licences, waivers or similar methods.
Novartis also established a clinical investigation team to enable rapid access to approved clinical requests and clinical evaluation support for its medicines to be repurposed for Covid-19.
Apart from hydroxychloroquine, Novartis plans to sponsor or co-sponsor trials of ruxolitinib and canakinumab for hospitalised Covid-19 patients.
Requests for investigator-launched trials of ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine and valsartan in Covid-19 indications have been granted.