News Release
Friday 22 January 2021
In large clinical trials conducted worldwide, treatments with full doses of coagulation (blood thinner) given to moderately ill patients admitted to the hospital for COVID-19 reduced the need for essential organ support, such as the need for ventilation. A trend in possible reduction of mortality was also observed and is further studied. With a large number of COVID-19 patients requiring hospitalization, these outcomes can also help reduce the congestion of intensive care units around the world.
Early in the pandemic, doctors around the world observed an increase in blood clots and inflammation in COVID-19 patients who affected several organs and led to complications such as lung failure, heart attack and stroke. Whether the provision of increased doses of blood thinners regularly administered to patients in the hospital would be safe and effective was unknown at the time.
Three clinical trial platforms spanning five continents in more than 300 hospitals have teamed up to test whether there is a greater benefit of full doses of heparin (blood thinners) in treating moderately ill hospitalized adults with COVID-19 compared to the lower dose heparin administered to prevent blood clots in patients in the hospital. 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.
Based on the interim results of more than 1,000 moderately ill patients admitted to the hospital, findings showed that the full doses of blood thinners, in addition to being safe, were better than the doses normally given to treat blood clots in hospitalized patients. prevent patients – with respect to the primary endpoint, which is the need for ventilation or other organ supportive interventions. The 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 the treatment of their COVID-19 patients.
As is normal for clinical trials, independent boards are overseen by these trials, which regularly review the data and consist of experts in ethics, biostatistics, clinical trials and blood clotting disorders. Informed of the deliberations of these supervisory degrees, all the trial plots stopped the registration.
However, research questions remain on how to further improve the clinical care of COVID-19 patients. This adaptation protocol is designed to allow different drugs to start, stop or combine during the study in response to emerging scientific data. This approach enables the rapid testing of additional drugs without compromising safety and the study will develop accordingly.
The trial results reported today are a complement to the group’s findings announced in December that routine use of a full dose anti-coagulation dose at the ICU in critically ill COVID-19 patients was not beneficial and in some patients could be harmful.
The three international trials include: the randomized, embedded, multifactorial adaptive platform test for community-acquired pneumonia (REMAP-CAP) therapeutic anticoagulation; Acceleration of COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and antithrombotic therapy to ameliorate COVID-19 (ATTACC) complications. The trials, which span four continents, have the common goal of assessing the benefit of full-dose blood thinners for the treatment of moderately ill or critically ill adults admitted to hospital for COVID-19, compared to a lower dose which is often used to prevent blood clots in patients in the hospital. To meet the challenge of this pandemic, investigators worldwide have joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 trial is led by a collaborative effort with several universities, including the University of Pittsburgh and the University of New York, New York.
The trials are supported by several international funding organizations, including the 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 (USA), the LifeArc Foundation, National Institutes of Health Research (UK), the National Health and Medical Research Council (AUS), Minderoo Foundation (AUS), and the PREPARE and RECOVER consortia (EU).
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