News release
Friday January 22, 2021
In large clinical studies conducted worldwide, full-dose anticoagulants (blood thinners) in moderately ill patients hospitalized for COVID-19 reduced the need for vital organ support, such as the need for ventilation. A trend in possible reduction in mortality has also been observed and is being further studied. Since a large number of COVID-19 patients need to be hospitalized, these outcomes can also help reduce overload in intensive care units around the world.
Early in the pandemic, doctors around the world saw increased blood clots and inflammation in COVID-19 patients affecting multiple organs and leading to complications such as lung failure, heart attack and stroke. Whether providing increased doses of blood thinners routinely administered to hospital patients would be safe and effective was not known at the time.
Three clinical trial platforms across five continents in more than 300 hospitals have collaborated to test whether there is a greater benefit of full doses of heparin (blood thinners) for the treatment of moderately ill adults in hospital with COVID-19 compared to the generally 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 have not received organ support such as mechanical ventilation when enrolled in the trial.
Based on the interim results of more than 1,000 moderately ill patients admitted to the hospital, findings showed that full doses of blood thinners were not only safe, but were also superior to 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 trial researchers are now working as quickly as possible to make the full results of the study available so that clinicians can make informed decisions about the treatment of their COVID-19 patients.
As is normal for clinical studies, these studies are monitored by independent boards that routinely review the data and are composed of experts in ethics, biostatistics, clinical studies and blood clotting disorders. Informed by the deliberations of these monitoring committees, all trial sites have discontinued registration.
However, research questions remain about how to further improve the clinical care of COVID-19 patients. This adaptive protocol is 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 safety and the study will evolve accordingly.
The study results reported today complement the findings of the group announced in December that routine use of full dose anticoagulation at baseline in ICU in critically ill COVID-19 patients was not beneficial and may be harmful to some patients.
The three international studies include: the randomized, embedded, multifactorial adaptive platform trial for therapeutic anticoagulant community-acquired pneumonia (REMAP-CAP); Acceleration of COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotic Intramural; and anti-thrombotic therapy to reduce complications of COVID-19 (ATTACC). The studies, which span four continents, have the common goal of assessing the benefit of full doses of blood thinners for the treatment of moderately ill or severely ill adults hospitalized for COVID-19, compared to a lower dose that is often used to prevent blood clots in hospitalized patients. To meet the challenge of this pandemic, researchers worldwide have joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 study is being led through a collaboration with several universities, including the University of Pittsburgh and New York University, New York City.
The studies are supported by multiple international funding organizations, including Canadian Institutes of Health Research (CAN), the National Institutes of Health’s National Heart, Lung and Blood Institute (USA), the Translational Breast Cancer Research Consortium, and the University of Pittsburgh Medical Center Learning While 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 (EU).
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