The NIH has launched two of three phase III clinical trials to test the safety and efficacy of different anticoagulants, including heparin and apixaban, in adult patients hospitalized with COVID-19, the agency announced on September 10.
Many patients who have died from the coronavirus developed thrombosis throughout their bodies, leading to life-threatening complications such as organ damage, heart attack, stroke, and pulmonary embolism, researchers have noted.
“There is currently no standard of care for anticoagulation in hospitalized COVID-19 patients, and there is a desperate need for clinical evidence to guide practice,” NIH Director Francis Collins, MD, PhD, said. (Editor’s note: The American Society of Hematology (ASH) is in the process of developing clinical practice guidelines on the use of anticoagulation in patients with COVID-19.)
In these trials, hospitalized patients will receive heparin at varying doses, while those being treated for COVID-19 in an outpatient setting will receive either a placebo, aspirin, or a low dose of apixaban. The third trial, which has not yet launched, will examine the effects of anticoagulation in patients hospitalized for moderate to severe disease who have been discharged.
These trials are part of the U.S. government’s Operation Warp Speed program to accelerate the development of treatments, tests, and vaccines against the coronavirus.