Novartis secured agreement from the U.S. Food and Drug Administration (FDA) to commence with a Phase III clinical trial involving 440 patients to investigate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19. The clinical trial drug will be provided by Sandoz, the generics and biosimilars division of Novartis. The study will be led by a prominent investigator from Johns Hopkins University. A controversial topic—hydroxychloroquine—will this study finally help the public understand whether the drug benefits COVID-19 patients?
This multi-site study will be led by principal investigator Richard E. Chaisson, MD, Professor of Medicine, Epidemiology and International Health at Johns Hopkins University in Baltimore Maryland. Starting the study within weeks, the company plans to report on results as soon as possible.
The sponsor will randomize patients into three groups, including 1) hydroxychloroquine, 2) hydroxychloroquine with azithromycin, and 3) placebo. Patients in all three groups of course receive the standard of care for COVID-19. Importantly, the study team organized this clinical trials in accelerate timeline—what would usually take months was compressed into a few weeks.
Opening up the Intellectual Property via Non-Exclusive Voluntary Licenses, Waivers
Novartis, recognizing the current crisis conditions, steps up and does the right thing by opening up and making the drug available via non-exclusive voluntary licenses, appropriate waivers and other mechanisms where needed.
Sandoz, a subsidiary of Novartis, will donate up to 130 million tablets of hydroxychloroquine to supply global clinical research initiatives in the event the study goes well and the benefits are proven. The company reports it has already donated 30 million tablets to the U.S. Department of Health and Human Services. Moreover, they continue to dispatch shipments to other countries as requests come line.
Novartis COVID-19 Clinical Investigation Team
The Swiss drug maker has formed a clinical investigational team to interface with the response to this global pandemic. For example, the group will work with those that request use of its drugs for clinical trials. Moreover, this group will co-sponsor clinical trials investigating ruxolitinib and canakinumab for hospitalized patients with COVID-19 infections.
Investigator-Initiated Clinical Trials
Novartis reports that their COVID-19 group has granted requests for investigator-initiated trials for use of their drugs including ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine and valsartan.
Sold under the brand name Plaquenil, the drug has been used to treat malaria where malaria remains sensitive to chloroquine. Other uses include treatment of arthritis, lupus, and porphyria and cutanea tarda. Taken by mouth, it is being intensely studied for a treatment for SARS-CoV-2. It was approved for medical use in the U.S. in 1955. And the drug is on the World Health Organization’s List of Essential Medicines, the safest and most effective medicines needed in a health system. By 2017, it was reported to be the 128th most commonly prescribed medication in America with over five million prescriptions.
Richard E. Chaisson, MD, Professor of Medicine, Epidemiology and International Health at Johns Hopkins University in Baltimore Maryland
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