NIH will launch clinical trial testing hydroxychloroquine in combination with azithromycin as a COVID-19 treatment

pharmafile | May 15, 2020 | News story | Medical Communications COVID-19, coronavirus 

The US National Institutes of Health (NIH) said it is launching a clinical trial testing hydroxychloroquine in combination with azithromycin in patients with mild to moderate COVID-19 symptoms.

The Phase 2b trial will enroll 2000 adult coronavirus patients who are experiencing fever, cough or a shortness of breath. Many of the subjects are anticipated to have serious underlying conditions like cardiovascular disease or diabetes, and the stidu will include many patients who are over 60 years old. They will be randomly assigned the drug combination or a placebo.

Patients will be asked to record their symptoms, the time they take their treatments and major hospitalisation events. Follow ups will be conducted by the researchers three and six months after treatments starts.

Dr Anthony Fauci, Director of the NIH’s National Institute of Allergy and Infectious Diseases, said that: “There is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomised, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes.”

The FDA recently issued an emergency-use authorisation for hydroxychloroquine, and related drug chloroquine, for treating patients with COVID-19 when a clinical trial is not feasible.

Conor Kavanagh

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