Press release
Friday, January 22, 2021
In a large worldwide clinical trial, full-dose (thin-blooded) anti-coagulation treatments given to moderately ill patients hospitalized for COVID-19 reduced the requirement to support vital organs – such as the need for ventilation. A trend in the possible reduction of mortality has also been observed and is still being studied. With a large number of COVID-19 patients requiring hospitalization, these results could also help reduce overload on intensive care units around the world.
At the beginning of the pandemic, doctors around the world noticed high rates of blood clots and inflammation in patients with COVID-19, which affected several organs and led to complications such as lung failure, heart attack and stroke. Whether delivering high doses of blood thinners routinely to hospitalized patients would be safe and effective was not known at the time.
Three clinical trial platforms spanning five continents in more than 300 hospitals have worked together to test whether there is a greater benefit of full doses of heparin (blood thinners) to treat hospitalized adults with moderate COVID-19 disease. compared to the lower dose of heparin given to prevent blood clots in hospitalized patients. Moderately ill patients are those who are not in intensive care and who have not received organ support, such as mechanical ventilation, upon enrollment in the study.
Based on the intermediate results of more than 1,000 moderately ill hospitalized patients, the results showed that full doses of blood thinners, in addition to being safe, were higher than the doses normally given to prevent blood clots in patients. hospitalized – in terms of the main objective which is the need for ventilation or other interventions to support the organs. Study investigators are now working as quickly as possible to make the full results of the study available so that clinicians can make informed decisions about treating patients with COVID-19.
As is normal for clinical trials, these studies are overseen by independent boards that routinely review data and are composed of experts in ethics, biostatistics, clinical trials, and blood clotting disorders. Informed of the deliberations of these supervisory commissions, all test sites stopped registering.
However, research questions remain on how to further improve the clinical care of patients with COVID-19. This adaptive protocol was designed to allow the initiation, discontinuation or combination of different drugs during the study in response to emerging scientific data. This approach allows rapid testing of additional agents without compromising safety, and the study will evolve accordingly.
The results of the study reported today complement the group’s findings announced in December that routine use of full-dose anticoagulation when it began in the ICU in critically ill COVID-19 patients was not beneficial and could have been harmful to some patients. .
The three international studies include: Randomized, embedded, multifactorial adaptive platform testing for therapeutic anticoagulation of community-acquired pneumonia (REMAP-CAP); Acceleration of COVID-19 Therapeutic interventions and vaccines-4 (ACTIV-4) Antithrombotic hospitalized; and Antithrombotic therapy for amelioration of COVID-19 complications (ATTACC). Studies on four continents have the common goal of evaluating the benefit of full doses of blood thinners to treat moderately ill or critically ill adults hospitalized for COVID-19, compared to a lower dose often used to prevent clots. of blood in hospitalized patients. To meet the challenge of this pandemic, investigators around the world have joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 process is driven by a collaborative effort with several universities, including the University of Pittsburgh and the University of New York, New York City.
The studies are supported by several international funding organizations, including the Canadian Institutes of Health Research (CAN), the National Institutes of Health, the National Heart, Lung and Blood Institute (USA), the Translational Consortium for Breast Cancer Research, and the University of Pittsburgh. Medical Center Learning During the Program (USA), LifeArc Foundation, National Institutes of Health Research (UK), National Council for Health and Medical Research (AUS), Minderoo Foundation (AUS) and the PREPARE and RECOVER consortiums (EU) ).
About the National Heart, Lung and Blood Institute (NHLBI): The NHLBI is the global leader in conducting and supporting research into heart, lung and blood diseases and sleep disorders that advance scientific knowledge, improve public health and save lives. For more information, visit www.nhlbi.nih.gov.
About the National Institutes of Health (NIH):
NIH, the national medical research agency, includes 27 institutes and centers and is a component of the US Department of Health and Human Services. NIH is the first federal agency to conduct and support basic, clinical, and translational medical research and investigate the causes, treatments, and cures of both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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