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A clinical trial has begun to evaluate whether the malaria drug hydroxychloroquine, given together with the antibiotic azithromycin, can prevent hospitalization and death from COVID-19, the National Institutes of Health reports.
The trial will enroll about 2,000 adults across the U.S. and study participants must have confirmed infection with SARS-CoV-2, the virus that causes COVID-19. They must also 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.
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This photo shows an arrangement of hydroxychloroquine tablets in Las Vegas. ((AP Photo/John Locher))
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“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 NIAID Director Anthony S. FaucI in a statement.
“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 infectious disease expert explained.
According to public officials, study 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.
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The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, 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.
The first participant enrolled today in San Diego, Calif., and participating sites across the country will be enrolling more people.
As of Thursday afternoon, the novel coronavirus has infected more than 1.4 million and killed at least 85,194 people in the U.S.