News release
Tuesday December 22, 2020
Three clinical trial platforms working together to test the effects of full doses of anticoagulants (blood thinners) in COVID-19 patients have suspended enrollment for one group of patients. Among critically ill COVID-19 patients who required support in the intensive care unit (ICU), therapeutic anticoagulants did not reduce the need for organ support. Enrollment for moderately ill COVID-19 patients hospitalized in the studies continues.
As is normal for clinical studies, these studies are monitored by independent boards that routinely review the data and are composed of experts in ethics, biostatistics, clinical studies and blood clotting disorders. Based on the deliberations of these monitoring committees, all trial sites have paused the enrollment of the most critically ill hospital patients with COVID-19. Possible damage in this subgroup could not be excluded. Increased bleeding is a known complication of a full dose of anticoagulation. The trials are working urgently to perform additional analyzes that will become available as soon as possible.
On the advice of the supervisory boards, patients who do not require IC care at the time of enrollment remain enrolled in the study. Whether the use of a full dose compared to a low dose of blood thinners leads to better outcomes in hospitalized patients with less severe COVID-19 disease remains a very important question. Patients who require a full dose of 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 started because clinicians observed that many patients who were ill with COVID-19, including those who died of the disease, formed blood clots throughout their bodies, even in their smallest blood vessels. This unusual clotting can cause multiple health complications, including lung failure, heart attack, and stroke.
Three international partners have come together in an unprecedented collaboration that has resulted in a multi-platform randomized controlled trial. The three international studies include: the randomized, embedded, multifactorial adaptive platform trial for therapeutic anticoagulation community-acquired pneumonia (REMAP-CAP); Acceleration of COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotic Intramural; and anti-thrombotic therapy to reduce complications of COVID-19 (ATTACC). The studies spanning four continents have the common goal of assessing the benefit of full doses of blood thinners for the treatment of moderately ill or severely ill adults hospitalized for COVID-19, compared to a lower dose that is commonly is used to prevent blood clots in hospitalized patients. To meet the challenge of this pandemic, researchers worldwide have joined forces to answer this question as quickly as possible. In the United States, the ACTIV-4 study is being led through a collaboration with several universities, including the University of Pittsburgh and New York University, 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 Health and Medical Research Council (Australia), the National Institutes of Health (USA) and the PREPARE and RECOVER consortia (EU).
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