Trial will enroll 2,000 patients with SARS-COV-2 who have fever, cough, and/or shortness of breath
FRIDAY, May 15, 2020 (HealthDay News) — The National Institute of Allergy and Infectious Diseases (NIAID) announced it is sponsoring a phase 2b clinical trial to evaluate the efficacy and safety of hydroxychloroquine and azithromycin in preventing hospitalization and death from COVID-19.
The NIAID, part of the National Institutes of Health, announced Thursday that the trial, called A5395, is being conducted by the AIDS Clinical Trials Group and will enroll 2,000 patients with SARS-COV-2 who have fever, cough, and/or shortness of breath. Patients will be randomly assigned to either short-term treatment with the hydroxychloroquine and azithromycin combination or placebo. The first patient enrolled on Thursday in San Diego. Patients in the experimental group will receive 400 mg of hydroxychloroquine twice on the first day and 200 mg twice daily for another six days; they will also receive 500 mg of azithromycin on the first day and 250 mg daily for another four days. Patients will record symptoms, treatment adherence, and major events such as hospitalization in a diary for 20 days and will be followed for six months.
“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,” Anthony S. Fauci, M.D., director of the NIAID, said in a press release.
Several other clinical trials on the use of hydroxychloroquine for treating COVID-19 are underway, including one recently launched by the National Heart, Lung and Blood Institute. The U.S. Food and Drug Administration issued an emergency use authorization on March 28 for hydroxychloroquine and medical-grade chloroquine to be used for hospitalized patients with COVID-19 in clinical trials or when appropriate if a clinical trial is not available or feasible.