Press release
Friday, January 22, 2021
In a large clinical trial conducted worldwide, full-dose anticoagulation (anticoagulant) treatments given to moderately ill patients hospitalized with COVID-19 reduced the requirement for vital organ support, such as the need for ventilation. A trend towards possible mortality reduction was also observed and is being studied further. With a large number of COVID-19 patients in need of hospitalization, these results could also help reduce overload in intensive care units around the world.
At the beginning of the pandemic, doctors around the world observed an increase in blood clot rates and inflammation among patients with COVID-19 that affected multiple organs and caused complications such as lung failure, heart attack and stroke. At the time, it was unknown whether providing more doses of routinely administered blood thinners to hospitalized patients would be safe and effective.
Three clinical trial platforms spanning five continents in more than 300 hospitals have been working together to see if there is a greater benefit from full doses of heparin (anticoagulants) for treating moderately ill hospitalized adults with COVID-19 compared to lower dose of heparin. administered to prevent blood clots in hospitalized patients. Moderately ill patients are those who are not in intensive care and who did not receive organ support such as mechanical ventilation during enrollment in the trial.
Based on the provisional results of more than 1,000 moderately ill patients admitted to the hospital, the findings showed that full doses of blood thinners, in addition to being safe, were higher than the doses normally given to prevent blood clots in hospitalized patients, with respect to the primary endpoint which is the need for ventilation or other organ support interventions. The researchers in the trial 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 their patients with COVID-19.
As is normal for clinical trials, these trials are overseen by independent boards that routinely review the data and are composed of experts in ethics, biostatistics, clinical trials, and blood clotting disorders. Informed by the deliberations of these supervisory boards, all test sites have stopped registering.
However, questions remain about research on how to further improve the clinical care of patients with COVID-19. This adaptive protocol has been designed to allow initiating, stopping, or combining different drugs during the study in response to emerging scientific data. This approach allows for rapid testing of additional agents without compromising safety and the study will evolve accordingly.
The results of the trial reported today complement the group’s findings announced in December that routine use of full-dose anticoagulation when initiated in the ICU in patients with critical COVID-19 was not beneficial and it may have been harmful in some patients.
The three international trials include: the trial of randomized, embedded multi-factor adaptive platforms, and therapeutic anticoagulation for community-acquired pneumonia (REMAP-CAP); Acceleration of COVID-19 (ACTIV-4) Interventional Antithrombotic Therapeutic Interventions and Vaccines; and Antithrombotic therapy to improve complications of COVID-19 (ATTACC). Trials, spanning four continents, have the common goal of evaluating the benefit of full doses of blood thinners for treating moderately ill or critically ill adults hospitalized for COVID-19, compared with a lower dose often used for prevent blood clots in hospitalized patients. To meet the challenge of this pandemic, researchers around the world joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 trial is being led by 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 (US) of the National Institutes of Health, the Translational Consortium of Breast Cancer and the University of Pittsburgh Medical Center. While Doing Program (USA), the LifeArc Foundation, the National Institutes of Health Research (UK), the National Council for Health and Medical Research (AUS), the Minderoo Foundation (AUS) and the PREPARE and RECOVER consortia ( EU).
Regarding the National Heart, Lung and Blood Institute (NHLBI): NHLBI is the world 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.
Regarding the National Institutes of Health (NIH):
NIH, the country’s medical research agency, includes 27 institutes and centers and is a component 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 research, and investigates 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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