Novartis to Begin Phase III Clinical Trial of Hydroxychloroquine in Hospitalized COVID-19 Patients

Novartis (Basel, Switzerland) has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease.

Hydroxychloroquine has long been used for the treatment of malaria and certain autoimmune diseases. The drug has garnered interest in the medical community after showing preliminary promise in small clinical studies, including one with co-administration with the antibiotic azithromycin. In addition, hydroxychloroquine has demonstrated antiviral activity against SARS-CoV-2 in laboratory tests.

The large trial sponsored by Novartis will be conducted at more than a dozen sites in the US. Researchers at the company compressed months of work into a few weeks to design the large clinical trial in order to rapidly respond to the need for COVID-19 disease treatments. Novartis plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible. Patients in the trial will be randomized into three groups. The first group or arm will receive hydroxychloroquine and the second group will receive hydroxychloroquine in combination with azithromycin, which is an antibiotic therapy, while the third group will receive placebo. Patients in all treatment groups are receiving standard of care for COVID-19.

The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis. The clinical trial complements a commitment by Novartis, through Sandoz, to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for treatment of COVID-19. As part of its research and development commitment, Novartis has formed a clinical investigation team to provide rapid access for approved clinical requests and support of clinical evaluation of its medicines to be repurposed and address the needs of patients with COVID-19 infections.

In addition to hydroxychloroquine, Novartis plans to sponsor or co-sponsor clinical trials to study ruxolitinib and canakinumab for hospitalized patients with COVID-19 infections. Requests for investigator-initiated trials have been granted for COVID-19-related clinical studies of ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine and valsartan.

“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”

“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,” said Richard Saynor, CEO of Sandoz.

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