Novartis has reached an agreement with US regulators to proceed with a Phase III clinical trial of hydroxychloroquine in hospitalised patients with COVID-19 disease.
The study, which will involve include around 440 patients, follows early preclinical and clinical evidence that hydroxychloroquine, which is used to treat malaria and certain autoimmune diseases, may be beneficial in the fight against the virus.
Patients in the trial will be randomised into three groups: the first will receive hydroxychloroquine, the second hydroxychloroquine in combination with the antibiotic azithromycin, and the third arm a placebo.
The Swiss drug giant said it plans to begin enrolment for the study within the next few weeks and is “committed to reporting results as soon as possible”.
Also, in order to secure broad access to hydroxychloroquine as quickly as possible, Novartis will said it would make any intellectual property within its control that relates to the use of hydroxychloroquine to treat or prevent COVID-19 “available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms”.
“We recognise 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 mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study.”
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