An Update: Is hydroxychloroquine effective for COVID-19?
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.
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?
Multiple studies have provided data demonstrating 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 a multicenter, randomized, open-label, controlled trial published in July 2020 by Cavalcanti and colleagues in the New England Journal of Medicine (NEJM), hydroxychloroquine use was studied in patients who were hospitalized with mild-to-moderate COVID-19.
A randomized, double-blind, placebo-controlled trial from Skipper and colleagues was conducted in 423 outpatients (not in the hospital) with early COVID-19. It was published in the Annals of Internal Medicine in July 2020.
A retrospective, observational study conducted from March to early May of 2020 did report a positive effect with hydroxychloroquine on hospitalized patient mortality, used alone and with azithromycin when compared to no treatment. The study from Arshad and colleagues was published in the International Journal of Infectious Diseases in August 2020. Authors note a limitation to their analysis was the retrospective, non-randomized, non-blinded study design.
Use of hydroxychloroquine is controversial, and has been politicized in the U.S. by various groups. Mixed studies have reported both a positive and negative effect, and data may not be robust or reliable: it can include data from study reviews, nonrandomized groups, retrospective research, observational data or from a statistically small sample size of patients.
Research for COVID is often quick to be published in non-peer reviewed, preprint online services due to the urgency of the pandemic. However, in general, preprint data should not be used to guide clinical practice. In addition, some hydroxychloroquine studies have been retracted due to lack of confidence in the data, including a Lancet study and one from the NEJM.
What is hydroxychloroquine used to treat?
Chloroquine and hydroxychloroquine are FDA-approved drugs in the U.S. The EUA revocation for COVID-19 does not change their approved uses.
Hydroxychloroquine sulfate is approved to treat and prevent malaria, as well as for treatment of lupus erythematosus and rheumatoid arthritis. Chloroquine phosphate is approved for the treatment and prevention of malaria only. The FDA has determined that these drugs are safe and effective when used as labeled for these conditions.
Hydroxychloroquine study for prevention after exposure to COVID-19
A randomized, double-blind, placebo-controlled study published online in the NEJM in June 2020 (Boulware, et al) looked at prevention of COVID-19 after exposure to the virus (post-exposure prophylaxis, or PEP).
I took hydroxychloroquine for COVID-19. Is it dangerous?
There are no known residual side effects for patients who received chloroquine phosphate or hydroxychloroquine for COVID-19 treatment under the emergency use authorization, as stated by the FDA.
However, you should never self-treat for COVID-19 disease with hydroxychloroquine or any other drug. Hydroxychloroquine has not been proven helpful for COVID-19 and may lead to stomach or heart side effects, as well as serious drug interactions.
If you have concerns about any side effect or drug interaction with your medications, always contact your doctor or other health care provider for advice.
What treatments or vaccines are available to treat COVID-19?
Remdesivir (brand name: Veklury) from Gilead Sciences was approved by the FDA on October 22, 2020 as the first treatment for SARS-CoV-2, the virus that causes COVID-19 and has led to a worldwide pandemic. Veklury is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, an antiviral agent that stops replication of the virus. Previously remdesivir was available only via an emergency use authorization (EUA) to treat COVID-19.
The incidence of adverse events associated with Veklury was similar to placebo in the ACTT-1 trial. The most common adverse reactions (≥5%) were nausea and increases in liver function tests (ALT and AST).
The FDA has also revised the pediatric Emergency Use Authorization (EUA) for Veklury. Under the EUA, it can be used to treat suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg (7.7 lb) to less than 40 kg (88 lb) OR hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.
In November 2020, the World Health Organization stated that they do not recommend remdesivir for hospitalized COVID-19 patients, regardless of disease severity, because there's no evidence that it reduces their need for ventilation or improves their outcomes or chances of survival.
Dexamethasone, a corticosteroid drug that has been approved for over six decades, has been shown to statistically lower mortality from COVID-19, especially among patients receiving mechanical ventilation. In studies from the RECOVERY group, death occurred in 25.7% of patients in the usual care group and 22.9% in the dexamethasone group (P<0.001).
On Dec. 11, 2020 the FDA issued an Emergency Use Authorization (EUA) for Pfizer's COVID-19 vaccine. In addition, the Moderna vaccine was authorized under an EUA on Dec. 18, 2020 and the Janssen (J&J) vaccine was given EUA on Feb. 27, 2021. Other vaccines, developed in other countries, are now also available worldwide.
The FDA has authorized emergency use of several other agents, including COVID-19 convalescent plasma, bamlanivimab and etesevimab, baricitinib in combination with remdesivir, and casirivimab and imdevimab. Note: In April 2021 the FDA revoked the EUA for bamlanivimab, when used alone, for mild-to-moderate COVID-19 treatment due to viral variant resistance.
Related: COVID-19: Prevention & Investigational Treatments
Bottom Line
Related medical questions
- An Update: Is hydroxychloroquine effective for COVID-19?
- An Update: Is hydroxychloroquine effective for COVID-19?
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