Hydroxychloroquine Phase 3 Study Launching in the USA
The US Food and Drug Administration (FDA) has reached an agreement with Switzerland based Novartis to proceed with a Phase 3 clinical trial to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease.
Announced on April 20, 2020, the randomized, double-blind, placebo-controlled clinical trial with approximately 440 patients will be conducted at more than a dozen sites in the USA.
Novartis said in a press release ‘it plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible.’
‘As the new virus continues to spread and claim lives around the globe, doctors and patients are eager for treatment options.’
‘In some cases, clinicians are evaluating drugs that have been approved for other diseases, hoping that these will also work against COVID-19.’
“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.
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 the treatment of COVID-19.
Sandoz has already donated 30 million tablets to the US Department of Health and Human Services and is dispatching further shipments to countries based on requests from governments around the world.
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.
Hydroxychloroquine has long been used for the treatment of malaria and certain autoimmune diseases. And recently, hydroxychloroquine has demonstrated antiviral activity against SARS-CoV-2 in laboratory tests.
Novartis is deeply dedicated to the global effort to combat COVID-19 and doing our part to support the stability of global healthcare systems.
More information about the Novartis response to COVID-19 is available on Novartis/Coronavirus.
COVID-19 treatment news published by Precision Vaccinations.