Hydroxychloroquine does not benefit adults hospitalized with COVID-19

Press release

Monday, November 9, 2020

A National Institutes of Health clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with 2019 coronavirus disease (COVID-19) officially concluded that the drug did not provide clinical benefit to patients. hospitalized patients. While not harmful, the first results in June, when the trial was stopped, indicated that the drug was not improving outcomes in patients with COVID-19. Final data and analyzes from the trial, which was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, will be published online Nov. 9 in the Journal of the American Medical Association.

The trial, called Results Related to COVID-19 Treated with Hydroxychloroquine in Hospital Patients with Symptomatic Illness (ORCHID), began after laboratory studies and preliminary reports suggesting that hydroxychloroquine – commonly used to treat malaria and rheumatic conditions like arthritis – may hold promise in the treatment of SARS -CoV-2, the virus responsible for COVID-19.

NHLBI’s Acute Lung Injury Prevention and Early Treatment (PETAL) Clinical Trials Network began the trial in April at 34 hospitals across the United States and enrolled 479 of 510 patients expected. In June, preliminary evidence indicated that hydroxychloroquine was unlikely to offer any benefit.

NIH officials said the study’s careful design, implementation and monitoring were critical to its results, along with a recommendation from a Data and Safety Oversight Board (DSMB) to stop try early.

“Having a rigorously designed clinical trial that captured clinically meaningful patient-centered results was essential to reach unequivocal conclusions about the use of hydroxychloroquine in COVID-19. ORCHID shows that hydroxychloroquine does not improve clinical outcomes in hospitalized COVID-19 patients, ”said James P. Kiley, Ph.D., director of the Division of Lung Disease at NHLBI. “We hope that this clear result will help practitioners make informed treatment decisions, and researchers will continue their efforts to research other possible safe and effective treatments for patients with this disease.

The ORCHID trial recruited participants between April 2 and June 19 who had a median age of 57 years. They included 290 Hispanic and black participants and 212 female participants. All participants received clinical care as indicated for their condition. Participants were randomly assigned to a treatment group and received 10 doses of hydroxychloroquine or a placebo for five days. The researchers then assessed the clinical status of each patient 14 days after being assigned to a treatment group. They used a scale of seven categories ranging from one (death) to seven (discharged from hospital and able to perform normal activities). The researchers also measured 12 additional outcomes, including death that occurred 28 days after participants were assigned to a treatment group.

By day 14, those who received hydroxychloroquine and those who received placebo had similar health status, with most participants in both groups discharged from the hospital and able to perform a range of activities. The number of participants in both treatment groups who died on day 14 was also similar. By day 28, 25 of 241 patients in the hydroxychloroquine group and 25 of 236 patients in the placebo group had died.

“The finding that hydroxychloroquine is not effective for the treatment of COVID-19 was consistent across all patient subgroups and across all outcomes assessed, including clinical status, mortality, failure of patients. ‘organs, the length of oxygen use and the length of hospital stay,’ said Wesley Self, MD, MPH, emergency room physician at Vanderbilt University Medical Center and a researcher with the PETAL Clinical Trials Network who led the ORCHID test. He also noted that the finding was consistent with similar trials in the UK and Brazil.

“Our diverse teams of clinicians and research staff have worked nimbly, under extremely difficult circumstances, to accomplish what NIH and the PETAL Network do best: landmark studies on issues important to patients with disease. fatal, ”said Samuel M. Brown, MD, MS, an intensive care physician at Intermountain Healthcare and a PETAL network investigator who helped lead the trial. “While we were hopeful that hydroxychloroquine would help, even this is an important finding as we work together to find effective treatments for COVID-19.”

As of November 2, 2020, the Centers for Disease Control and Prevention reported more than 9.1 million cases of COVID-19 and more than 230,000 deaths in the United States. Numerous other randomized clinical trials are currently evaluating the efficacy and safety of other agents compared to placebo in the urgent race for effective therapies to treat COVID-19.

ORCHID The trial was funded by grants NIH / NHLBI 3 U01 HL123009-06S1, U01HL123009, U01HL122998, U01HL123018, U01HL123023, U01HL123008, U01HL123031, U01HL123004, U01HL123027, U01123010, U01HL01123027, U01123010, U01HL01123027, U01123010, U01HL01123027, U01123010, U01HL01123027 , U01123010, U01HL01123027 In addition, the research was supported by the UL1TR001102 and UL1TR002541 awards from the National Center for Advancing Translational Sciences.

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the world leader in conducting and supporting heart, lung and blood disease and sleep disorders research that advances scientific knowledge, improves public health and saves lives. For more information visit https://www.nhlbi.nih.gov/.

About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, comprises 27 institutes and centers and is a component of the US Department of Health and Human Services. The NIH is the principal federal agency that conducts and supports basic, clinical and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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