Press release
Friday, January 22, 2021
In a large clinical trial conducted worldwide, full-dose anticoagulation treatments (anticoagulants) 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 being studied. With a large number of COVID-19 patients requiring hospitalization, these results may also help to reduce the burden on intensive care units worldwide.
Early in the pandemic, doctors around the world observed increased rates of blood clots and inflammation among patients with COVID-19, which affected multiple organs and led to complications such as lung failure, heart attack and stroke. It was not known whether providing larger doses of blood thinners routinely administered 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 test whether there is a greater benefit of full doses of heparin (blood thinners) to treat moderately ill adults hospitalized with COVID-19 compared to the lowest dose of heparin normally 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, at the time of enrollment in the study.
Based on the provisional results of more than 1,000 moderately ill patients admitted to the hospital, the results showed that full doses of anticoagulants, in addition to being safe, were higher than the doses normally administered to prevent blood clots in hospitalized patients – with respect to primary endpoint which is the need for ventilation or other organ support interventions. The study’s researchers are now working as quickly as possible to make the full results of the study available so that doctors can make informed decisions about their patients’ treatment with COVID-19.
As is normal for clinical trials, these trials are overseen by independent boards that routinely review the data and are comprised of specialists in ethics, biostatistics, clinical trials and blood clotting disorders. Informed by the deliberations of these supervisory boards, all test sites have stopped enrolling.
However, research questions remain on how to further improve the clinical care of 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 study results reported today complement the group’s findings announced in December that the routine use of full-dose anticoagulation when started in the ICU 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, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Acceleration of Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotic COVID-19; and Antithrombotic Therapy to Improve Complications of COVID-19 (ATTACC). The trials, spanning four continents, have the common goal of assessing the benefit of full doses of anticoagulants to treat moderately ill or critically ill adults hospitalized by COVID-19, compared to a lower dose often used to prevent blood clots in patients hospitalized. To address the challenge of this pandemic, researchers around the world have joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 study is being conducted by a collaborative effort with several universities, including the University of Pittsburgh and New York University in New York City.
The tests are supported by several international funding organizations, including the Canadian Institutes of Health Research (CAN), the National Heart, Lung and Blood Institute of the National Institutes of Health (USA), the Translational Breast Cancer Research Consortium and the University of Pittsburgh Medical While Learning Doing Program (US), the LifeArc Foundation, National Institutes of Health Research (UK), National Health and Medical Research Council (AUS), Minderoo Foundation (AUS) and the PREPARE and RECOVER consortia (HUH).
About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung and blood disorders and sleep disorders 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, includes 27 institutes and centers and is a component of the United States Department of Health and Human Services. The NIH is the leading federal agency that conducts and supports basic, clinical and translational medical research, and is investigating 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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