22 Sep NIH expands clinical trials to test convalescent plasma against COVID-19

Rigorous studies to build on earlier efforts to test the experimental treatment

National Institutes of Health (NIH)

Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19.

Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and neutralize SARS-CoV-2, the virus that causes COVID-19, as well as other components that may contribute to an immune response.

“The evidence on convalescent plasma as a treatment for severe cases of COVID-19 is promising but incomplete. We need to carry out rigorous randomized control clinical trials to determine how this therapy can improve outcomes,” said NIH Director Francis S. Collins, M.D., Ph.D. “While the world waits for an effective vaccine, it is vital that we simultaneously expand the options for available treatments for those currently suffering from the worst effects of this disease.”

The trials expect to enroll hospitalized patients across the country at academic and community-based hospitals. Participants will be randomly assigned to receive the treatment or a placebo. Outcomes will be compared with respect to clinical improvement measures and resource needs, such as ventilators. Both trials currently are enrolling participants and anticipate results as early as this fall. Read more …