Source: Genetic Engineering & Biotechnology News
The lack of treatment options for COVID-19 patients, potential promise in repurposing drugs, and controversy surrounding the anti-malarial drug hydroxychloroquine have created a storm of questions about the drug’s efficacy that the National Institute of Allergy and Infectious Diseases (NIAID) is ready to answer. To do that, the organization is sponsoring a large randomized, controlled clinical trial to determine whether hydroxychloroquine, given in combination with the antibiotic azithromycin, can prevent hospitalization and death due to COVID-19.
The clinical trial has begun—with the first person enrolled in San Diego, CA—to evaluate the efficacy of the drugs against COVID-19. The NIAID, part of the NIH, is sponsoring the trial, which is being conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG). Teva Pharmaceuticals is donating medications for the study.
“We urgently need a safe and effective treatment for COVID-19. Repurposing existing drugs is an attractive option because these medications have undergone extensive testing, allowing them to move quickly into clinical trials and accelerating their potential approval for COVID-19 treatment,” said Anthony S. Fauci, MD, NIAID director. “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.”
The Phase IIb trial will enroll approximately 2,000 adults across the United States. Study participants must have confirmed infection with SARS-CoV-2, and be experiencing fever, cough, and/or shortness of breath. The investigators anticipate that many of those enrolled will be 60 years of age or older or have a comorbidity associated with developing serious complications from COVID-19, such as cardiovascular disease or diabetes. Participants will be randomly assigned to receive short-term treatment with either hydroxychloroquine and azithromycin or matching placebos. People living with HIV and pregnant and breastfeeding women also are eligible to participate in the study.
Read the full article here: https://www.genengnews.com/news/nih-launches-clinical-trial-to-study-hydroxychloroquine-efficacy-in-covid-19/