Press release
Tuesday, December 22, 2020
Three clinical trial platforms working together to test the effects of full-dose anticoagulants (anticoagulants) in patients with COVID-19 have stopped enrollment in a group of patients. Among patients with critical COVID-19 disease who needed intensive care unit (ICU) support, therapeutic anticoagulant drugs did not reduce the need for organ support. Enrollment continues in moderately ill hospitalized COVID-19 patients.
As is normal for clinical trials, these trials are overseen by independent boards that routinely review the data and are composed of experts in ethics, biostatistics, clinical trials, and blood clotting disorders. Informed by the deliberations of these supervisory boards, all test sites have stopped enrolling hospitalized patients with critical illness with COVID-19. Potential damage in this subgroup could not be ruled out. Increased bleeding is a known complication of full-dose anticoagulation. The trials are working urgently to conduct additional analyzes that will be made available as soon as possible.
On the recommendation of the supervisory boards, patients who do not need ICU care at the time of enrollment will continue to be enrolled in the trial. A very important question is whether the use of full doses compared to low-dose anticoagulants leads to better outcomes in hospitalized patients with less severe COVID-19 disease. Patients requiring full-dose anticoagulants for another medical indication are not included in these trials.
COVID-19 is associated with significant inflammation and clinical and pathological evidence of generalized blood clots. These trials were initiated because doctors observed that many patients with COVID-19, including those who died from the disease, formed blood clots all over the body, even in the smaller blood vessels. This unusual clotting can cause multiple health complications, such as lung failure, heart attack, and stroke.
Three international partners have come together in an unprecedented collaboration that resulted in a randomized controlled trial across multiple platforms. The three international trials include: the trial of randomized, embedded multi-factor adaptive platforms, and therapeutic anticoagulation for community-acquired pneumonia (REMAP-CAP); Acceleration of COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4) Inpatient Antithrombotic; and Antithrombotic therapy to improve complications of COVID-19 (ATTACC). Trials spanning 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 with a lower dose often used to prevent blood clots in hospitalized patients. To meet the challenge of this pandemic, researchers around the world joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 trial is being led by a collaborative effort with several universities, including the University of Pittsburgh and the University of New York, in New York City.
The trials are supported by multiple international funding organizations, including the Canadian Institutes of Health Research, the National Institute for Health Research (UK), the National Council for Health and Medical Research (Australia), the Institutes National Health (USA) and the PREPARE and RECOVER consortia (EU).
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