NIH will fund a large, randomized, placebo-controlled Phase 3 clinical trial to test several existing prescription and over-the-counter medications to treat symptoms of COVID-19. The trial is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership and overseen by NCATS.
The ACTIV-6 trial will explore a pool of up to seven drugs approved by the U.S. Food and Drug Administration for other conditions — an approach called drug repurposing — and study their safety and effectiveness in treating mild to moderate COVID-19 in adults. Because the drugs under consideration already have been tested in humans, repurposing could deliver COVID-19 treatment options sooner.
NCATS’ Clinical and Translational Science Awards (CTSA) Program will partner with the Patient-Centered Outcomes Research Institute (PCORI) to expedite enrollment of up to 13,500 participants who have tested positive for COVID-19 and are not hospitalized. The Duke Clinical Research Institute will serve as the clinical coordinating center, and the Vanderbilt Institute for Clinical and Translational Research at Vanderbilt University Medical Center will serve as the trial’s data coordinating center. Enrollment will focus on communities that are significantly affected by COVID-19 but lack access to major academic medical centers, where large clinical trials usually take place.