Full-dose anticoagulants reduced need for survival and improved outcomes in hospitalized patients with COVID-19



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Press release

Friday 22 January 2021

In a large clinical trial conducted around the world, full-dose anti-coagulation (anticoagulants) treatments given to moderately ill patients hospitalized with COVID-19 reduced the need for vital organ support – such as the need for ventilation. A trend towards a possible reduction in mortality has also been observed and is under investigation. With a large number of COVID-19 patients requiring hospitalization, these findings could also help reduce overload in intensive care units around the world.

At the start of the pandemic, doctors around the world observed increased levels of blood clots and inflammation in patients with COVID-19, which affected multiple organs and led to complications such as lung failure, seizure. heart disease and stroke. It was not known at the time whether giving increased doses of anticoagulants to hospital patients would be safe and effective.

Three clinical trial platforms spanning five continents in more than 300 hospitals have worked together to test whether there is greater benefit of full doses of heparin (anticoagulants) for treating moderately ill hospitalized adults with COVID-19 compared to the lower dose of heparin generally administered to prevent blood clots in hospitalized patients. Moderately ill patients are those who are not in intensive care and who did not receive organic support such as mechanical ventilation when enrolling in the trial.

Based on the interim results of over 1,000 moderately ill patients admitted to hospital, the results showed that full doses of anticoagulants, in addition to being safe, were higher than doses normally given to prevent blood clots. in hospitalized patients – with regard to the primary endpoint which is the need for ventilation or other organ support interventions Trial investigators are now working as fast as possible to make results complete of the study available so clinicians can make informed decisions about the treatment of their COVID-19 patients.

As is normal with clinical trials, these trials are overseen by independent committees that regularly review the data and are comprised of experts in ethics, biostatistics, clinical trials and blood clotting disorders. Informed of the deliberations of these supervisory boards, all test sites have stopped registrations.

However, research questions remain on how to further improve clinical care for patients with COVID-19. This adaptive protocol was designed to allow different drugs to be started, stopped or combined during the study in response to emerging scientific data. This approach allows for rapid testing of additional agents without compromising security and the study will evolve accordingly.

The trial results released today complement the group’s findings announced in December that the routine use of full-dose anticoagulation when started in the intensive care unit in critically ill patients with COVID- 19 was not beneficial and may have been harmful in some patients.

The three international trials include: the Randomized, Integrated, Multifactorial Adaptive Platform Trial for Community-Based Pneumonia Therapeutic Anticoagulation (REMAP-CAP); Accelerate therapeutic interventions against COVID-19 and vaccines-4 (ACTIV-4) Hospitalized antithrombotics; and antithrombotic therapy to improve complications of COVID-19 (ATTACC). The trials, which span four continents, share the common goal of evaluating the benefit of full doses of anticoagulants for treating moderately ill or critically ill adults hospitalized with COVID-19, compared to a lower dose often used to prevent blood clots 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 trial is being conducted as a collaborative effort with several universities, including the University of Pittsburgh and New York University, New York.

The trials are supported by several international funding organizations, including the Canadian Institutes of Health Research (CAN), the National Heart, Lung, and Blood Institute (United States) of the National Institutes of Health, the Translational Breast Cancer Research Consortium and the University of Pittsburgh Medical Center Learning While Doing Program (United States), the LifeArc Foundation, the National Institutes of Health Research (United Kingdom), the National Health and Medical Research Council (AUS), the Minderoo Foundation (AUS) and the PREPARE and RECOVER (EU) consortia.

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 disorder research that advances scientific knowledge, improves public health and saves lives. For more information, visit www.nhlbi.nih.gov.

About the National Institutes of Health (NIH):NIH, the country’s medical research agency, comprises 27 institutes and centers and is part 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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