Authors: Medically reviewed by Drugs.com. Last updated on Feb 2, 2021.
Multiple studies provide data that hydroxychloroquine (brand name: Plaquenil) does not provide a medical benefit for hospitalized patients with COVID-19. Hydroxychloroquine, an FDA-approved prescription drug used for malaria, rheumatoid arthritis and lupus erythematosus, has been suggested as a possible treatment or preventive for COVID-19 based on demonstrated antiviral or immune system activity.
In June 2020, the FDA revoked the emergency use authorization (EUA) of oral hydroxychloroquine and chloroquine phosphate for the treatment of COVID-19. An EUA can allow quicker access to critical medical products when there are no approved alternative options.
- Based on an evaluation of the scientific data to date, the FDA concluded that chloroquine and hydroxychloroquine are not likely to be effective in the treatment of COVID-19 for the authorized uses in the EUA.
- In addition, the risk for serious side effects with hydroxychloroquine and chloroquine phosphate are a concern. This includes the possibility of adverse cardiovascular (heart) events such as an abnormal heart rhythm which could be fatal.
- Additional worldwide studies are still ongoing to assess the use of these agents for the treatment or prevention or COVID-19, including early-stage outpatient and use with supplements such as zinc or vitamin D or with azithromycin. However, the FDA states hydroxychloroquine should not be used outside of clinical trials in the U.S.
The World Health Organization (WHO) and the U.S. National Institutes of Health (NIH) have also stopped studies evaluating hydroxychloroquine for the treatment of COVID-19 due to a lack of benefit. Current NIH and US treatment guidelines do not recommend use of hydroxychloroquine and chloroquine phosphate for COVID-19 treatment outside of clinical studies.
Although earlier studies suggested that hydroxychloroquine could inhibit the SARs-CoV-2 virus and was more potent than chloroquine, recent studies do not support the use of hydroxychloroquine or chloroquine phosphate. The FDA stated on June 15, 2020 that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19.
Do studies show hydroxychloroquine is not effective for COVID-19?
Yes, multiple studies provide data that hydroxychloroquine is ineffective in the treatment of SARS-CoV-2, the virus that causes COVID-19 disease.
The RECOVERY Trial from the University of Oxford is a large, randomized, controlled, open-label study evaluating a number of potential treatments for patients hospitalized with COVID-19. The study is being conducted by researchers at the University of Oxford in the UK (the hydroxychloroquine arm is now halted).
- In the RECOVERY Trial, investigators reported that there was no beneficial effect or reduction of death in hospitalized patients with COVID-19 receiving hydroxychloroquine.
- In this study, 1561 patients received hydroxychloroquine and were compared to 3155 patients receiving standard care only. No difference was found in the primary endpoint, which was the incidence of death at 28 days (26.8% hydroxychloroquine vs. 25% usual care, 95% CI 0.96-1.23; p=0.18).
- In addition, hydroxychloroquine treatment was associated with an increased length of stay in the hospital and increased need for invasive mechanical ventilation.
- Based on this data, investigators stopped enrollment in the RECOVERY hydroxychloroquine arm on June 5th, 2020.
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