The National Institutes of Health (NIH) has started a clinical trial to determine whether a combination of hydroxychloroquine (malaria drug) and azithromycin (antibiotic) can prevent hospitalization and death from COVID-9, the disease caused by the new coronavirus.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is sponsoring the trial. The study is conducted by the NIAID-funded AIDS Clinical Trials Group (ACTG). Teva Pharmaceuticals is donating the medications for the trial.
The trial will enroll approximately 2,000 patients with confirmed COVID-19 infection across the United States. The investigators anticipate that most of the participants would be 60 years of age or above or have a risk of developing serious COVID-19 complications, especially those who have diabetes and cardiovascular disease.
Participants will be divided into two groups. One group will receive short-term treatment with hydroxychloroquine and azithromycin, while the other will receive a placebo.
NIAID Director Dr. Anthony Fauci said, “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.”
“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,” he added.
In the United States, COVID-19 has, so far, affected more than 1.4 million and killed over 86,900 people.
Currently, there are no specific drugs or treatments approved by the U.S. Food and Drug Administration (FDA) to treat COVID-19. Hydroxychloroquine is an FDA-approved drug to prevent and treat malaria. It is also commonly prescribed for the treatment of rheumatoid arthritis and lupus.
Some studies have shown that hydroxychloroquine, alone or in combination with azithromycin, may benefit people with COVID-19, while others found that the drug has no benefits at treating coronavirus.
ACTG Chair Dr. Judith Currier said, “This study will provide key data to aid responses to the COVID-19 pandemic. We are pleased to be able to leverage ACTG’s existing infrastructure for HIV treatment clinical trials to quickly implement this important study.”
The investigators are expected to enroll participants quickly given the rise in COVID-19 incidence and the initial results are expected by the end of this year. You can go to the official website of the NIH to know more about the trial and enroll for it if you are a COVID-19 victim.
