Novartis Launches Phase III Study of Hydroxychloroquine in COVID-19 Patients

Swiss pharma giant Novartis will launch a Phase III trial assessing hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The trial will be conducted at more than a dozen sites across the United States.

Novartis said this morning that it plans to begin study enrollment of the 440 patient trial over the next few weeks and is committed to reporting results as soon as possible. Novartis’ generic subsidiary Sandoz manufactures hydroxychloroquine for use as a treatment for malaria, lupus and rheumatoid arthritis and will supply the drug for the trial. Hydroxychloroquine is a drug that has been touted by President Trump as a “game-changer” in the fight against COVID-19, the disease caused by the novel coronavirus supported by anecdotal evidence of patient response to the drug. As a result of the anecdotal evidence and the hope that the drug will benefit patients, Novartis earlier this year agreed to donate up to 130 million tablets of hydroxychloroquine to support other studies of the drug, as well as compassionate use programs in hospitals. To achieve broad access to hydroxychloroquine as quickly as possible in these extraordinary circumstances, Novartis said it will make any intellectual property within its control that relates to the use of hydroxychloroquine in COVID-19 available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms.

John Tsai, chief medical officer at Novartis and head of its Global Drug Development program, said the company recognizes the importance of clinically determining whether or not hydroxychloroquine will be beneficial for patients with COVID-19 disease.

Novartis is not the only company or organization running a clinical trial for hydroxychloroquine against COVID-19. The University of Minnesota and the University of Washington are conducting studies, as is the National Institutes of Health. Last week, a study in China showed that hydroxychloroquine did not help patients clear the virus better than standard care.

In the Novartis study, patients will be randomized into three groups. The first group or arm will receive hydroxychloroquine. The second group will receive hydroxychloroquine in combination with azithromycin, an antibiotic therapy that has been given to many COVID-19 patients along with the malaria drug. The third group will receive a placebo. Patients in all treatment groups are receiving standard of care for COVID-19.

Other companies are also studying older medications against COVID-19, including Roche, Gilead Sciences, Incyte and more. On Friday, BioSpace reported that there were signs from a study of Gilead’s remdesivir, an Ebola drug, which was effective in treating COVID-19. While the study was small and caution has been urged about reading too much into the results, the drug appeared to benefit the COVID-19 patients in a small University of Chicago study.  

In addition to the Phase III hydroxychloroquine study for COVID-19, Novartis plans to sponsor or co-sponsor clinical trials to study Jakafi (ruxolitinib), a drug co-developed with Incyte, and Ilaris (canakinumab) for hospitalized patients with COVID-19 infections. Incyte told BioSpace this morning that Jakafi will specifically be studied in patients with COVID-19 associated cytokine storm, a severe immune response where the immune system begins to attack the body and healthy cells rather than the virus.