Hydroxychloroquine Study Launches for Non-Hospitalized COVID-19

Hydroxychloroquine is back in the news – and not just because President Donald Trump said he was taking it as a prophylaxis against COVID-19. The NIH has launched another study of the antimalarial combined with azithromycin in non-hospitalized COVID-19 patients. Here are more details.

WASHINGTON – With President Donald Trump’s claim that he was taking daily doses of hydroxychloroquine, a drug he's promoted as a potential novel coronavirus cure, the antimalarial is back in the news again.

But that is not the only reason. Medical experts and the U.S. Food and Drug Administration have questioned the effectiveness of the drug for COVID-19, which is why a National Institutes of Health agency is launching another clinical trial.

The study is seeking to determine if hydroxychloroquine, given together with the antibiotic azithromycin, can prevent hospitalization and death from COVID-19. The trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and will be using medications donated by Teva Pharmaceuticals.

The Phase 2b trial will enroll approximately 2,000 adults at sites across the United States. Study participants must have confirmed infection with SARS-CoV-2, the virus that causes COVID-19, and be experiencing fever, cough and/or shortness of breath.

The expectation from investigators is that many of the participants will end up being 60 or older and have a comorbidity associated with developing serious complications from COVID-19, such as cardiovascular disease or diabetes. The patients will be randomly assigned to receive short-term treatment with either hydroxychloroquine and azithromycin or matching placebos.

“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, MD. “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.”

No specific therapeutics are currently FDA-approved to treat COVID-19 patients, although hydroxychloroquine is FDA-approved to prevent and treat malaria, as well as to treat the autoimmune diseases rheumatoid arthritis and lupus.

Some preliminary reports have suggested that hydroxychloroquine, alone or in combination with the FDA-approved antibiotic azithromycin, may benefit people with COVID-19. Numerous clinical trials are planned or underway, including a recently launched study supported by NIH’s National Heart, Lung and Blood Institute evaluating the safety and effectiveness of hydroxychloroquine for treatment of adults hospitalized with COVID-19.

On March 28, FDA issued an Emergency Use Authorization to allow hydroxychloroquine and medical-grade chloroquine to be distributed from the Strategic National Stockpile and prescribed by doctors to hospitalized adolescents and adults with COVID-19, as appropriate, when a clinical trial is not available or feasible.

As part of the current study, participants will receive oral medications to take at home. Those randomly assigned to the experimental treatment group will take 400 milligrams (mg) of hydroxychloroquine twice on the first day and 200 mg twice daily for an additional six days. They also will take 500 mg of azithromycin on the first day and 250 mg daily for an additional four days. The control group will receive equivalent numbers of placebo pills. Neither the participants nor the study team will know who received experimental treatment or placebo until the end of the trial.

Per the study’s design, participants will record their symptoms, adherence to treatment, and major events such as hospitalizations in a diary for 20 days. Researchers will follow up with participants by telephone during this period, and, if possible, the patients will come to the clinical research site for an in-person visit at day 20. Additional follow-ups will be conducted by telephone three and six months after treatment starts.

Defined as the main outcome is whether hydroxychloroquine and azithromycin can prevent hospitalization and death due to COVID-19. Researchers also will focus on the safety and tolerability of the experimental treatment for people with SARS-CoV-2 infection. Side effects ranging from headache and nausea to, rarely, heart rhythm problems that can be life-threatening have been reported with the drugs.

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