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November 24, 2020
Hydroxychloroquine doesn’t benefit hospitalized COVID-19 patients
At a Glance
- In a final analysis of study data, researchers concluded that the medication hydroxychloroquine provides no benefit to adults hospitalized with COVID-19.
- Ongoing clinical trials are testing other therapies for the disease.
Hydroxychloroquine is a prescription medication used to treat malaria and autoimmune conditions like lupus and rheumatoid arthritis. The drug gained attention when early reports suggested it might benefit COVID-19 patients. These reports were based on preliminary studies in cells and small studies of COVID-19 patients that lacked control groups.
In March 2020, the FDA issued an emergency use authorization allowing doctors to treat hospitalized COVID-19 patients with hydroxychloroquine or the related drug chloroquine. The drugs became part of routine care for COVID-19 patients at many hospitals.
Larger, well-designed studies were needed to determine if hydroxychloroquine was a safe and effective treatment for SARS-CoV-2 infection. In April, NIH launched a clinical trial at 34 hospitals nationwide to test the medication. The study was funded by NIH’s National Heart, Lung, and Blood Institute (NHLBI).
By June, the study was stopped because interim results showed the drug neither caused harm nor improved patient outcomes. The trial had enrolled 479 of the expected 510 patients. Earlier in the month, the FDA had revoked its emergency use authorization for hydroxychloroquine and chloroquine. It cited a lack of benefit as well as risks, such as serious heart rhythm problems.
Researchers led by Dr. Wesley Self of Vanderbilt University have now completed a final analysis of the study data. Their findings were published in JAMA on November 9, 2020.
The 479 patients who enrolled were randomly assigned to receive hydroxychloroquine or a placebo. The trial included 290 Latino and Black participants. The median patient age was 57. They received 10 doses of either hydroxychloroquine or a placebo over five days (400 mg twice daily on the first day, then 200 mg twice daily for the following four days).
Researchers assessed each patient’s condition 14 days after being assigned to a treatment group. They used a seven-category scale ranging from one (death) to seven (discharged from the hospital and able to perform normal activities). The results showed no significant difference between the hydroxychloroquine and placebo groups.
The scientists also found no differences in any of 12 additional outcomes, which included mortality 28 days after assignment to a treatment group or time to recovery. Based on the data, they concluded that hydroxychloroquine was not an effective treatment.
“We hope this clear result will help practitioners make informed treatment decisions and researchers continue their efforts pursuing other possible safe and effective treatments for patients suffering with this disease,” says Dr. James P. Kiley of NHLBI.
Studies in the United Kingdom and Brazil had similar results. Researchers continue to evaluate several other possible treatments for COVID-19, which has caused more than 250,000 deaths in the U.S. to date.
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- Coronavirus (COVID-19)
- Coronavirus Prevention Network
- Coronavirus (COVID-19) (CDC)
References: Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial. Self WH, Semler MW, Leither LM, Casey JD, Angus DC, Brower RG, et al. JAMA. 2020 Nov 9:e2022240. doi: 10.1001/jama.2020.22240. Online ahead of print. PMID: 33165621.
Funding: NIH’s National Heart, Lung, and Blood Institute (NHLBI) and National Center for Advancing Translational Sciences (NCATS).