The U.S. Food and Drug Administration and Novartis have reached an agreement to permit the Swiss company to go ahead with a clinical trial of the anti-malaria drug hydroxychloroquine for those who have contracted the coronavirus, The Hill reported on Monday.
Novartis announced it will start enrollment for the third phase of the clinical trial for some 440 patients within the next few weeks and that the study will be carried out in more than a dozen labs across the United States.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Novartis' chief medical officer and head of the company’s global drug development. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
The Swiss pharmaceutical firm added that it is committed to reporting results as soon as possible.
In recent weeks President Donald Trump has repeatedly promoted hydroxychloroquine, even as top health officials on the White House coronavirus task force emphasized there is no scientific evidence the drug is effective in treating coronavirus, for which there is no cure.
Novartis said the clinical trial follows up on its commitment to donate up to 130 million tablets of hydroxychloroquine to supply worldwide clinical research efforts if the medicine is proven beneficial for treatment of COVID-19.
The Health and Human Services Department announced last month that it received 30 million such doses, according to The Hill.
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