A clinical trial evaluating the combination of hydroxychloroquine and azithromycin for the treatment of coronavirus disease 2019 (COVID-19) has begun, with the first patient enrolled in San Diego, California. The trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The phase 2b trial is expected to include roughly 2000 participants with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who are experiencing fever, cough, and/or shortness of breath. Patients will be randomized to receive hydroxychloroquine 400mg twice on the first day and 200mg twice daily for another 6 days plus azithromycin 500mg on the first day and 250mg daily for an additional 4 days or matching placebos.
The primary end point of the study is to determine whether the combination therapy can prevent hospitalization and death due to COVID-19. Patients will be asked to record their symptoms in a diary and to report any major adverse events including hospitalization through day 20. They will also be examined, when possible, at the clinical research site at day 20, with additional follow-up via telephone calls at 3 and 6 months post treatment.
“Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes,” said NIAID Director Anthony S. Fauci, MD.
Additionally, the safety and tolerability of the treatment regimen will also be evaluated. Recently, the FDA issued a safety alert warning that the use of these agents should be limited to clinical trial settings or for treating certain hospitalized patients under the Emergency Use Authorization because of reported cardiovascular complications such as QT interval prolongation, ventricular tachycardia, and ventricular fibrillation.
The trial, which is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG), is expected to enroll quickly and initial results may be available later this year. “This study will provide key data to aid responses to the COVID-19 pandemic,” said ACTG Chair Judith Currier, MD, of the University of California, Los Angeles. “We are pleased to be able to leverage ACTG’s existing infrastructure for HIV treatment clinical trials to quickly implement this important study.”
For more information visit actgnetwork.org.