NIH’s ACTIV Trial Suspends Enrollment of Critically Ill Patients With COVID-19

The National Institutes of Health (NIH) announced that it is pausing enrollment of patients with severe COVID-19 in three trials that are evaluating anticoagulants for individuals hospitalized with COVID-19.

Among critically ill patients with COVID-19 who required intensive care unit support, full doses of anticoagulants did not reduce the need for organ support. Based on these data, trial oversight boards recommended suspending enrollment of the most critically ill hospitalized patients with COVID-19. Increased bleeding is a known complication of full-dose anticoagulation and the boards also determined that a potential for harm in this subgroup could not be excluded. “The trials are working urgently to undertake additional analyses which will be made available as soon as possible,” according to a press release from the NIH.

Enrollment in the trials continues for moderately ill hospitalized patients with COVID-19.

Supported by three international partners spanning four continents, the three multiple platform randomized controlled trials include the Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) Therapeutic Anticoagulation; Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics Inpatient; and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC). In the U.S., the ACTIV-4 trial is being led in collaboration with several universities, including the University of Pittsburgh and New York University.

The trials shared a common goal of assessing the benefit of full-dose anticoagulants in treating patients hospitalized with moderate-to-severe COVID-19 infection, compared with the lower doses commonly used as thrombosis prophylaxis in hospitalized patients.

The trials are funded by organizations around the world, including the Canadian Institutes of Health Research, the U.K.’s National Institute for Health Research, the National Health and Medical Research Council in Australia, the NIH, and the EU’s PREPARE and RECOVER consortia.

Sources: NIH press release, December 22, 2020; The New York Times, December 22, 2020.