Press release
Tuesday, December 22, 2020
Three clinical trial platforms working together to test the effects of full doses of anticoagulants (blood thinners) in patients with COVID-19 discontinued enrollment for a group of patients. Among critically ill patients with COVID-19 requiring intensive care (ICU) care, therapeutic anticoagulant drugs have not reduced the need for organ support. Enrollment continues for moderately ill COVID-19 hospitalized patients in studies.
As is normal for clinical trials, these studies are overseen by independent councils that regularly review the data and are composed of experts in ethics, biostatistics, clinical trials, and blood clotting disorders. Informed of the deliberations of these supervisory commissions, all study sites stopped enrolling the most critically ill patients hospitalized with COVID-19. A potential injury in this subgroup could not be ruled out. Increased bleeding is a known complication of full-dose anticoagulation. Processes are working urgently to carry out further analyzes which will be made available as soon as possible.
On the recommendation of the supervisory boards, patients who do not require medical care at the time of enrollment will continue to be enrolled in the process. Whether the use of the full dose compared to low-dose blood thinners leads to better outcomes in hospitalized patients with less severe disease COVID-19 remains a very important question. Patients who require full-dose blood thinners for another medical indication are not included in these studies.
COVID-19 is associated with significant inflammation and clinical and pathological evidence of widespread blood clots. These studies were launched because clinicians observed that many patients with COVID-19, including those who died of the disease, formed blood clots all over their bodies, even in the smallest blood vessels. This unusual coagulation can cause multiple health complications, including lung failure, heart attack and stroke.
Three international partners came together in an unprecedented collaboration, resulting in a randomized controlled study with several platforms. The three international studies include: Testing the randomized, embedded, multifactorial adaptive platform for therapeutic anticoagulation for community-acquired pneumonia (REMAP-CAP); Acceleration of COVID-19 Therapeutic interventions and vaccines-4 (ACTIV-4) Antithrombotic hospitalized; and Antithrombotic therapy for amelioration of COVID-19 complications (ATTACC). Studies on four continents have the common goal of evaluating the benefit of full doses of blood thinners to treat moderately ill or critically ill adults hospitalized for COVID-19, compared to a lower dose often used to prevent blood clots. 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 process is driven by a collaborative effort with several universities, including the University of Pittsburgh and New York University, New York City.
The studies are supported by several international funding organizations, including the Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Council for Research in Health and Medicine (Australia), the National Institutes of Health (USA) and PREPARE and RECOVER consortia (EU).
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