Full-dose blood thinner reduced need for life support and better outcomes in hospitalized COVID-19 patients

News release

Friday, January 22, 2021

In a large clinical trial conducted worldwide, full-dose anti-coagulation (blood thinning) treatment for moderately ill patients hospitalized for COVID-19 reduced the need for vital organ support Gives – such as the need for ventilation. A trend in the possible reduction of mortality was also observed and is being studied. Along with the large number of hospitalized COVID-19 patients, these results may also help reduce the surcharge at intensive care units worldwide.

At the onset of the epidemic, physicians around the world saw increased rates of blood clots and inflammation in COVID-19 patients, affecting several organs and causing complications such as lung failure, heart attack, and stroke. It would be safe and effective to provide increased doses of routine blood thinner doses to hospitalized patients that were unknown at the time.

Three clinical trial platforms spread across five continents in more than 300 hospitals are working together to test whether full doses of heparin (blood thinners) have greater benefits than heparin doses, usually less Compared with heparin dose for treatment in moderately ill hospitals with COVID-19. 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 at trial enrollment.

Based on the interim results of more than 1,000 sick patients hospitalized, the findings showed that in addition to being safe, full doses of blood thinners, usually from doses given to prevent blood clots in hospitalized patients Was better – the primary endpoint requiring ventilation or other organ supportive intervention. Trial investigators are now working as quickly as possible to provide the full results of the study so that physicians can make informed decisions about the treatment of their COVID-19 patients.

As is common for clinical trials, these tests are overseen by independent boards that regularly review the data and are made up of experts in ethics, biology, clinical trials, and blood clotting disorders. All testing sites have withheld enrollment, informed by the idea of ​​these oversight boards.

However, research questions remain on how to further improve 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 enables rapid testing of additional agents without compromising safety and the study will develop accordingly.

Trial results complement the group’s findings announced today in December that regular use of full-dose anti-coagulation was not beneficial when initiated in the ICU in critically ill COVID-19 patients and may be harmful in some patients is.

Three international trials include: Randomized, Embedded, Multi-Factor Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) therapeutic anticoagulation; Accelerated COVID-19 therapeutic intervention and TK-4 (ACTIV-4) antithromobotics inpatient; And antithrombotic therapy for substantial complications of COVID-19 (ATTACC). Trials spread across four continents have the common goal of assessing the benefit of full doses of blood thinner doses for COVID-19 for the treatment of moderately ill or critically ill adults in hospitalized patients Low doses are often used to prevent blood clots. To meet the challenge of this epidemic, investigators worldwide joined forces to answer this question. In the United States, the ACTIV-4 test is being performed under a collaborative effort with several universities, including the University of Pittsburgh and the University of New York, New York City.

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

About National Heart, Lung and Blood Institute (NHLBI): NHLBI is a global leader in the research and support of heart, lung and blood diseases and sleep disorders that advance scientific knowledge, improve public health and save lives. For more information, go to www.nhlbi.nih.gov.

About National Institutes of Health (NIH):The NIH, the nation’s medical research agency, consists of 27 institutions and centers and is a component of the US Department of Health and Human Services. The NIH is the primary federal agency conducting and supporting basic, clinical and translational medical research, and investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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