Friday 22 January 2021
In a large clinical trial conducted worldwide, full-dose anticoagulant therapy (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 the subject of further study. With a large number of COVID-19 patients requiring hospitalization, these findings could also help reduce overload in intensive care units around the world.
At the start of the pandemic, doctors around the world observed increased rates of blood clots and inflammation in patients with COVID-19, which affected multiple organs and led to complications such as lung failure, seizure. heart disease and stroke. It was not known at the time whether the administration of increased doses of anticoagulants given routinely to hospitalized patients would be safe and effective.
Three clinical trial platforms spanning five continents in more than 300 hospitals have worked together to test whether there is a greater benefit of full doses of heparin (anticoagulants) for treating moderately ill hospitalized adults with COVID- 19 compared to the generally lower heparin dose. given to prevent blood clots in hospitalized patients. Moderately ill patients are those who are not in intensive care and who did not receive organic support such as mechanical ventilation when enrolling in the trial.
Based on the interim results of over 1,000 moderately ill patients admitted to hospital, the results showed that full doses of anticoagulants, in addition to being safe, were higher than doses normally given to prevent blood clots. in hospitalized patients – with regard to the primary endpoint which is the need for ventilation or other organ support interventions. Investigators in the trial are now working as fast as possible to make the full study results available so clinicians can make informed decisions about the treatment of their COVID-19 patients.
As is normal for clinical trials, these trials are overseen by independent committees that regularly review data and are comprised of experts in ethics, biostatistics, clinical trials, and blood clotting disorders. Informed by the deliberations of these supervisory boards, all trial sites have stopped recruiting.
However, research questions remain on how to further improve clinical care for COVID-19 patients. 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 trial results reported today complement the group’s findings announced in December that the routine use of full-dose anticoagulation when started in intensive care in critically ill COVID-19 patients was not not beneficial and may have been harmful in some patients.
The three international trials include: the Randomized, Integrated, Multifactorial Adaptive Platform Trial for Community Acquired Pneumonia (REMAP-CAP) Therapeutic anticoagulation; Acceleration of therapeutic interventions and COVID-19-4 (ACTIV-4) vaccines Antithrombotics Hospitalized patient; and antithrombotic therapy to improve complications of COVID-19 (ATTACC). The trials, which span four continents, share the common goal of evaluating the benefit of full doses of anticoagulants for treating moderately or severely ill adults hospitalized with COVID-19, compared to a lower dose often used to prevent clots blood in hospitalized patients. To meet the challenge of this pandemic, investigators around the world have joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 trial is being conducted as a collaborative effort with several universities, including the University of Pittsburgh and New York University, New York City.
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), the Translational Breast Cancer Research Consortium and the University of Pittsburgh Medical Center Learning. While Doing Program (United States), the LifeArc Foundation, the National Institutes of Health Research (United Kingdom), the National Health and Medical Research Council (AUS), the Minderoo Foundation (AUS) and the PREPARE and RECOVER consortia (EU ).
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