Press release
Tuesday, December 22, 2020
Three clinical trial platforms working together to test the effects of full doses of antidepressants (blood thinners) in COVID-19 patients have stopped enrollment for one group of patients. Among critically ill COVID-19 patients requiring intensive care unit (ICU) support, antidepressant treatment drugs did not reduce the need for organ support. Registration continues for moderately ill COVID-19 patients in the trials.
As is typical for clinical trials, these trials are led by independent boards that regularly review the data and are made up of experts in ethics, biostatistics, clinical trials, and falls. -blooding orders. Knowing from the consideration of these boards of directors, all test sites have suspended the registration of the most critical patients in the hospital with COVID-19. Harm in this subgroup could not be prevented. Increased swelling is a known complication of full-dose antidepressants. The tests are working quickly to produce additional analyzes that will be available as soon as possible.
On the recommendation of the boards of directors, patients who do not require ICU care at the time of enrollment will remain enrolled in the trial. Whether full-dose use compared to low-dose blood thinners leads to better outcomes in hospitalized patients with less severe COVID-19 infection remains an important question. Patients who require full-dose blood thinners for other medical indication are not included in these tests.
COVID-19 is associated with severe inflammation and clinical and pathologic evidence of extensive blood clots. These trials were launched because clinicians have found that many patients infected with COVID-19, including those who died from the disease, formed blood clots all over their bodies. , even in their smallest blood vessels. This abnormal clotting can cause a number of health problems, including lung failure, heart attack, and stroke.
Three international partners have come together in an unprecedented collaboration that resulted in a randomized platform-controlled trial. The three international trials include: the Applied, Accelerated, Multifactorial Platform Test for Community-Infectious Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 therapeutic interventions and vaccines-4 (ACTIV-4) Patient Antithrombotics; and Antithrombotic Medicine to reduce COVID-19 complications (ATTACC). The sole purpose of trials circulating in four continents is to evaluate the benefit of full doses of blood thinners for the treatment of moderately ill or critically ill adults in the continent. hospitalization for COVID-19, compared with a lower dose that is often used to prevent blood clots in hospitalized patients. To meet the challenge of this pandemic, researchers from all over the world have come together to answer this question as soon as possible. In the United States, the ACTIV-4 trial is led by a collaborative effort with several universities, including the University of Pittsburgh and New York University, New York City.
The trials are supported by a number of international funding bodies including the Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Council for Health and Medical Research (Australia), National Institutes Health (US), and the PREPARE and RECOVER coalition (EU).
About the National Heart, Lung and Blood Institute (NHLBI):NHLBI is a global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advance scientific knowledge, improve public health, and life saving. For more information, visitwww.nhlbi.nih.gov.
About the National Institutes of Health (NIH):
NIH, the nation’s medical research agency, comprises 27 Institutes and Centers and is part of the U.S. Department of Health and Human Services. NIH is the leading federal agency that conducts and supports basic, clinical, and translational medical examination, and examines the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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