News release
Monday, November 9, 2020
A national organization of health clinical trials evaluating the safety and efficacy of hydroxychloroquine for the treatment of adults with coronavirus disease 2019 (COVID-19) has formally concluded that the drug does not provide any clinical benefit to hospitalized patients. Although no cause for harm was found, preliminary findings when the trial was closed in June indicate that the drug COVID-19 is not improving results in patients. Final data and analysis of the trial, provided by the National Heart, Lung, and Blood Institute (NHLBI) as part of the NIH, Nov. 9. Journal of the American Medical Association.
In this trial, Comfide-19-related outputs are treated with symptomatic disease (ORCID) in impatients by hydroxychloroquine, after laboratory studies and preliminary reports suggested that hydroxychloroquine should be used for treatment and treatment with melanoma. May be. -Covi-2, the virus that causes COVID-19.
Trials of Acute Lung Injury Prevention and Early Treatment (PETAL) of the Clinical Trials Network, NHLBI, began in April at 34 hospitals in the United States and reported 479 of the expected 510 patients. As of June, preliminary evidence shows that hydroxychloroquine is unlikely to offer any benefit.
NIH officials said careful study, implementation and monitoring of the study is key to its results, as well as a recommendation by the Data and Safety Monitoring Board (DSMB) to stop the trial as soon as possible.
“Strictly designed clinical trials in which the patient was focused, clinically meaningful results were crucial to reaching a clear conclusion about the use of hydroxychloroquine in COVID-19. ORCID shows that hydroxychloroquine does not improve clinical outcomes in hospitalized COVID-19 patients, ”said James P., PhD, director of lung diseases at NHLBI. “We hope that this clear result will help practitioners make informed treatment decisions and that researchers will continue their efforts to find other potentially safe and effective treatments for patients with this disease.”
The Orchid trial registered participants between April 2 and June 19 who were 57 years old. It included 290 Hispanic and Black participants and 212 female participants. All participants received clinical care as directed for their condition. Participants were randomly assigned to the treatment group and received 10 doses of hydroxychloroquine or placebo in five days. The researchers then assessed the clinical condition of each patient, 14 days after assignment to the treatment group. They used a scale of seven categories ranging from one (death) to seven (discharged from the hospital and able to perform normal activities). The researchers also measured 12 additional outcomes, with participants dying 28 days after being assigned to the treatment group.
On the 14th day, those who received hydroxychloroquine and those who received a placebo had similar health conditions, most participants from both groups were discharged from the hospital and were able to perform a variety of activities. The number of participants in both treatment groups who died on day 14 was also the same. On the 28th, 25 of the 241 patients in the hydroxychloroquine group and 25 of the 236 patients in the placebo group died.
“Hydroxychloroquine, which is not effective for the treatment of covid-1 of, was consistent across all evaluation outcomes, including patient subgroups and clinical status, mortality, organ failure, duration of oxygen use, and length of hospital stay,” said Wadley Self. , MD, MPH, Emergency Medicine Physician at Wonderbilt University Medical Center and Petal Clinical Trials Network Investigator who led the Orchid Trial. He also noted that the findings were consistent with similar tests in the United Kingdom and Brazil.
“Our diverse teams of clinicians and research staff have worked very hard, in very difficult circumstances, to accomplish what NIH and the PETAL Network do best: a ‘gold standard’ study of important questions for patients suffering from life-threatening situations,” said Samuel M. Brown. Said. , MD, MS, InterimVanthan Healthcare and Critical Care Physician of the Petal Network Investigator, who helped lead the trial. “While we hope that hydroxychloroquine will help, this is also an important result because we are working together to find an effective treatment for Covid-19.”
Nov. 2 By 2020, the Centers for Disease Control and Prevention has reported more than 9.1 million deaths from COVID-19 and more than 230,000 deaths in the United States. Several other randomized clinical trials are currently evaluating the effectiveness and safety of other agents against placebo in the race for effective treatment urgency for the treatment of Covid-19.
Orchid offers trial funded by the NIH / NHLBI 3 U01 HL123009-06S1, U01HL123009, U01HL122998, U01HL123018, U01HL123023, U01HL123008, U01HL123031, U01HL123004, U01HL123027, U01HL123010, U01HL123033, U01HL122989, U01HL123022 and U01HL123020. In addition, the research was supported by the National Center for Advanced Translational Science Awards UL1TR1001102 and UL1TR1002541.
About the National Heart, Lung and Blood Institute (NHLBI): The NHLBI is a global leader in research and support for heart, lung and blood diseases and sleep disorders that will advance scientific knowledge, improve public health and save lives. For more information, visit https://www.nhlbi.nih.gov/.
About National Institutes of Health (NIH):
The NIH, the nation’s medical research agency, comprises 27 institutions and centers and is a component of the U.S. Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and is investigating the causes, treatment, and cure for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Turning NIH2 Discovery into Health®
Study
Effect of hydroxychloroquine on 14-day clinical condition in hospitalized patients with COVID-19. DOI: 10.1001 / jama.2020.22240.
.
