NIH Launches Clinical Trials of Antithrombotics for COVID-19
Adaptive design allows evaluation of various doses, types of blood thinners in outpatients, inpatients
MONDAY, Sept. 14, 2020 (HealthDay News) -- Two of three planned adaptive phase 3 clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19 have launched, according to an announcement by the National Institutes of Health (NIH).
The two current trials under the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4) Antithrombotics initiative will occur at more than 100 sites around the world and will involve patients who have not been hospitalized and those currently hospitalized. A third trial will soon start focusing on patients discharged after hospitalization for moderate-to-severe disease.
The adaptive protocol design allows different blood thinners to be started, stopped, or combined in response to emerging trial data. The ACTIV-4 Antithrombotics Inpatient trial will study the safety and effectiveness of low or high doses of heparin to prevent clotting events and improve outcomes in hospitalized COVID-19 patients. The ACTIV-4 Antithrombotics Outpatient trial will investigate whether anticoagulants or antithrombotic therapy (placebo, aspirin, or a low or therapeutic dose of apixaban) can reduce life-threatening cardiovascular or pulmonary complications in newly diagnosed COVID-19 patients not requiring hospital admission. Researchers will also collect patient data and blood samples to identify potential drug targets and biomarkers associated with the risk for developing COVID-19 complications.
"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 S. Collins, M.D., Ph.D., said in a statement. "Conducting trials using multiple existing networks of research sites provides the scale and speed that will get us answers faster."