Phase III Clinical Trial of Hydroxychloroquine to Begin


Over the weekend, one of the world’s largest pharmaceutical companies, Novartis, reached an agreement with the U.S. Food and Drug Administration to proceed with a Phase III clinical trial of hydroxychloroquine—the drug President Trump has often touted as a treatment for COVID-19, despite it being, as yet, unproven—in hospitalized patients.

Hydroxychloroquine has recently garnered interest in the medical community after showing preliminary promise in small clinical studies. It has long been used for the treatment of malaria and certain autoimmune diseases.

Approximately 440 patients will participate in the trial, and will be randomized into three groups: the first will receive hydroxychloroquine, the second will receive hydroxychloroquine and the antibiotic azithromycin, and the third will receive a placebo.

In a statement released on Monday, April 20, Novartis said they plan to begin enrollment for the study within the next few weeks, and is “committed to reporting results as soon as possible.”

Norvartis also said in the statement that they will “make any intellectual property within our 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,” as part of their response to COVID-19.

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