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news.Novartis has entered into an agreement with the US Food and Drug Administration (FDA) to conduct a clinical trial with the hydroxychloroquine in hospitalised COVID-19 patients.
Novartis will evaluate the efficacy of hydroxychloroquine in hospitalised COVID-19 patients. (Credit: Gerd Altmann from Pixabay)
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Sponsored by Novartis, the trial will recruit around 440 patients to assess the efficacy of malaria drug to treat hospitalised patients with COVID-19 disease.
Novartis’ generics and biosimilars division Sandoz will supply the drug required for the clinical trial, which will be carried out at over a dozen sites in the US.
Sandoz CEO Richard Saynor said: “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.”
Novartis aims to commence the recruitment of patients in the study within the next few weeks and determined to report results rapidly.
Novartis will randomise the patients in the trial into three groups, of which first group or arm will secure hydroxychloroquine.
The second group will secure hydroxychloroquine in combination with antibiotic therapy azithromycin, while the third group will receive a placebo. Patients in all treatment groups will secure the standard of care for COVID-19.
Novartis has established a clinical investigation team for quick access to approved clinical requests and supports clinical assessments of its medicines to be repurposed and address the requirements of patients with COVID-19 infections.
The company also intends to sponsor or co-sponsor clinical studies to evaluate ruxolitinib and canakinumab for hospitalised patients with COVID-19 infections.
According to the company, requests for investigator-initiated studies were granted for COVID-19-related clinical studies of ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine and valsartan.
Novartis global drug development head and chief medical officer John Tsai said: “We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease.
“We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
Recently, Novartis has collaborated with TScan Therapeutics for the discovery and development of T cell receptor (TCR) therapies to treat solid tumours.
