The National Institutes of Health (NIH) has launched two of three adaptive Phase 3 clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19, according a news release from the NIH.
Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines initiative, these trials will be conducted at more than 100 sites around the world and will involve patients in various clinical settings – those who have not been hospitalized, those currently hospitalized and those discharged after hospitalization for moderate to severe disease, the NIH said.
The trial for hospitalized COVID-19 patients and the trial for patients with COVID-19 who have not been hospitalized are now underway. A third trial to start later will focus on patients discharged after hospitalization for moderate to severe COVID-19 disease. All three clinical trials will be coordinated and overseen by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, and funded through Operation Warp Speed.
Researchers have noted that many patients who have died from COVID-19 had formed blood clots throughout their bodies, including in their smallest blood vessels. This unusual clotting, one of many life-threatening effects of the disease, has caused multiple health complications, from organ damage to heart attack, stroke and pulmonary embolism.
ACTIV-4 Antithrombotics will be recruiting at sites with significant COVID-19 burden. The adaptive design of the protocol allows different blood thinners to be started, stopped or combined during the study in response to emerging trial data. This approach accelerates the timeline for testing different agents without compromising safety.
"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," said NIH Director Francis S. Collins, MD, PhD. "Conducting trials using multiple existing networks of research sites provides the scale and speed that will get us answers faster."
ACTIV-4 Antithrombotics Inpatient will investigate the safety and effectiveness of using varying doses of the blood thinner heparin to prevent clotting events and improve outcomes in hospitalized COVID-19 patients. Patients will be assigned to either a low or high dose of heparin, and as the trial progresses, additional antithrombotics may be tested, depending on the trial results. All participants in the study will continue to receive clinical care as indicated for their condition.
