NIH Launches Clinical Trials of Antithrombotics for COVID-19

Adaptive design allows evaluation of various doses, types of blood thinners in outpatients, inpatients

protective mask,pills, syringes, Stethoscope on blue background with coronavirus

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."

More Information

Physician’s Briefing Staff

Physician’s Briefing Staff

Published on September 14, 2020

Read this Next
About UsOur ProductsCustom SolutionsHow it’s SoldOur ResultsDeliveryContact UsBlogPrivacy PolicyFAQ