This week, the U.S. Department of Veterans Affairs (VA) announced a new clinical trial to study convalescent plasma for treating seriously ill COVID-19 patients as part of a larger effort to give veterans faster access to potential COVID-19 treatments and test the treatments’ effectiveness.
The trial is the first of multiple studies in VA Coronavirus Research and Efficacy Studies (VA CURES), a master protocol that offers a standardized framework for studying potential treatments for COVID-19 without the need for a new study design and protocol each time.
“This trial will go a long way toward helping in the fight against COVID-19,” said U.S. VA Sec. Robert Wilkie on Monday. “VA CURES will provide valuable information that will benefit our veterans who are battling COVID-19, as well as other patients and the medical community in general.”
The trial will enroll around 700 veterans with COVID-19 who are hospitalized at VA medical centers. A study team will randomize the study volunteers to receive either convalescent plasma or a saline placebo, and track and assess recovery and effects of the treatment.
Convalescent plasma is donated by people who have recovered from COVID-19 and have antibodies against the virus in their blood. Antibodies are proteins the body makes to fight infections.
The U.S. Food and Drug Administration (FDA) previously authorized the use of convalescent plasma as an investigational treatment for COVID-19 through FDA’s expanded access program. The program, used widely throughout the nation, including at many VA sites, ended Aug. 28. FDA has since authorized the emergency use of the therapy based on the available scientific evidence to date. FDA stresses further evidence from rigorous trials — such as the new VA study — is “critically important” for establishing safety and efficacy.