A phase 3 study evaluating the use of hydroxychloroquine for the treatment of hospitalized patients with coronavirus disease 2019 (COVID-19) is expected to begin within the next few weeks, according to the trial sponsor Novartis.
The placebo-controlled study will enroll approximately 440 patients and will be conducted at more than a dozen sites in the US. Patients will be randomized into 3 cohorts: hydroxychloroquine, hydroxychloroquine in combination with azithromycin, or placebo; all patients will receive standard of care for COVID-19 throughout the trial.
“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. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
In a press release, Novartis announced that it will make its hydroxychloroquine intellectual property available to support broad access if the drug is approved for COVID-19. The Company has committed to donating up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts. The US Department of Health and Human Services (HHS) also recently accepted a donation of 30 million doses of hydroxychloroquine from Sandoz, the generics and biosimilars division of Novartis.
Hydroxychloroquine (an analog of chloroquine) is approved by the Food and Drug Administration for the treatment of malaria, lupus, and rheumatoid arthritis. The treatment, however, is not without risks. Recently, the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) published a joint statement cautioning clinicians about the potential cardiovascular complications associated with the drug.
In addition, a retrospective analysis of data collected from US Veterans Health Administration medical centers showed that hydroxychloroquine, both with or without azithromycin, was not associated with reduced risk of mechanical ventilation in patients hospitalized with COVID-19. Moreover, the study reported an increased risk in death in those treated with hydroxychloroquine, highlighting the need for results from randomized controlled trials before allowing for widespread use.
For more information visit novartis.com.