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www.fdanews.com/articles/196746-novartis-to-launch-phase-3-hydroxychloroquine-trial-for-covid-19

Novartis to Launch Phase 3 Hydroxychloroquine Trial for COVID-19

April 21, 2020

Novartis said it will begin enrollment in the next few weeks for a phase 3 clinical trial to evaluate hydroxychloroquine for treatment of hospitalized COVID-19 patients. The trial will include more than 440 participants at more than a dozen U.S. sites.

If the product is approved for COVID-19, Novartis will release its intellectual property relating to hydroxychloroquine for use by other drugmakers.

The company also committed to donating 130 million hydroxychloroquine tablets for global clinical research efforts.

Last week, Oxford University’s Center for Evidence-Based Medicine reported that it knew of 142 COVID-19 trials involving chloroquine or hydroxychloroquine. Although only five have reported clinical observations so far, the available data do not support the drug’s use in preventing or treating the virus, the center said.

And there are other indications that the anti-malaria drug may not be effective. In a study published in the Lancet, the Global Rheumatology Alliance said 110 patients with chronic rheumatologic diseases were taking medications, such as hydroxychloroquine, prior to being diagnosed with COVID-19. — James Miessler