The National Institutes of Health is expanding trials of convalescent plasma to treat Covid-19, according to an agency announcement Tuesday. The trials are receiving $48 million through Operation Warp Speed.
The trials are enrolling hospitalized patients in two randomized placebo-controlled clinical trials at sites around the country.
Convalescent plasma is the blood product that is taken from volunteers who have recovered from Covid-19. That plasma has antibodies — proteins the body naturally produces to fight against a threat like a virus — that can help stimulate an immune response in someone who is sick.
“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,” NIH Director Dr. Francis Collins said in a press release. “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.”
In the trials, volunteers will be randomly assigned to receive standard care or the plasma treatment. Scientists will then compare the results to see if the treatment is effective. Results should be available in the fall.
Some background on this: In August, the US Food and Drug Administration announced emergency authorization for the treatment. The authorization was based on early observational studies that showed the therapy held some promise. These two trials are considered the gold standard that should provide definitive evidence if the treatment works against Covid-19.
So far, 105,802 patients who have recovered from Covid-19 have donated their plasma and 83,610 Covid-19 patients have been treated with this approach in the US, according to Mayo Clinic’s UScovidplasma.org.