Two randomized, placebo-controlled clinical trials funded by the U.S. National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19, according to the NIH.
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, the NIH said in the release on Tuesday.
Convalescent plasma is blood plasma taken from the 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 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, said the NIH.
One trial, called Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients, expects to enroll approximately 1,000 hospitalized patients 18 years or older with respiratory symptoms of COVID-19.
The other trial, called Passive Immunity Trial of Our Nation for COVID-19, is expanding to enroll about 1,000 participants. Participants are 18 years or older with acute respiratory infection symptoms and laboratory-confirmed SARS-CoV-2 infection.
