AstraZeneca said today it has launched a 30,000-patient Phase III trial in the U.S. of AZD1222, the COVID-19 vaccine it is co-developing with the University of Oxford and a spinout—a study that will account for most of the 50,000 participants on which the company intends to assess the vaccine.
The Phase III D8110C00001 trial (NCT04516746) is intended to evaluate the safety, efficacy, and immunogenicity of AZD1222 (formerly ChadOx1 nCoV-19) for the prevention of COVID-19. Participants will be randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control.