On August 25, Business Insider offered an overview of FDA’s authorization for convalescent plasma to treat COVID-19 while noting that, “some scientists worry it’s too soon.” Back in 1918 during the Spanish Flu, doctors found, “they could treat sick patients with the blood of those who had already recovered.” And now the FDA’s EUA allows for COVID-19 patients to get this treatment earlier in an infection, when it may be most effective. But Dr. Thomas File, who is president of the Infectious Diseases Society of America opined, “While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment.”
Mouth Sinai and Mayo Clinic Data Promising
As of August, over 2,700 hospitals have used plasma therapy via an expanded-access program steered by the Mayo Clinic, and over 100,000 patients have gotten plasma through this program. Limits on plasma use include the required speed of transfer, blood type compatibility, and supply limits. For these reasons Pharma and researchers tend to see it as an “interim therapy” until we have a vaccine. In one study awaiting peer review, patients who got plasma within three days of being diagnosed, “had a 35% lower mortality rate than those who were treated four or more days after their diagnosis. But more comparisons with untreated or placebo patients is needed. In May the Mount Sinai early data saw some benefit with 39 patients who received the treatment. Similarly, early reports from the Mayo Clinic show that plasma was associated with a 57% reduction in mortality rate.
New Orleans Early Adopter on Plasma
On September 15, New Orleans’ The Lens reported on how that community was adapting to FDA’s authorization. Once the EUA was issued at the end of August, hospitals could use plasma without being in a trial. New Orleans doctors have led the way on plasma therapy for COVID-19. “We started collecting convalescent plasma back in April. We were one of the first in Louisiana, maybe throughout the country, collecting convalescent plasma,” according to Tim Peterson, medical director for two Louisiana blood banks who is affiliated with Tulane School of Medicine. Key, the EUA can create an ethical dilemma: RCTs are needed, but is it right to deny some folks this treatment? One solution here being attempted at Vanderbilt University trials is to build-in a trial step in which, if it appears strongly that the plasma is helping, the trial could be ended early.
Plasma Donations Needed
Finally, on September 17, Cincinnati’s FOX 19 noted that plasma donors are needed for new research. The University of Cincinnati and Johns Hopkins University are looking at the effectiveness of convalescent plasma used on an outpatient basis. Researchers say that it has proven effective but that now, “the procedure is only done in hospitals.” Dr. David Sullivan of Johns Hopkins says, “My 80-year-old parents, they don’t want to go out and risk getting the infection because they know right now their only recourse if they get sick is hope they are not in the 10 or 20% who go to the hospital—But if you knew you could get a single one-stop one-hour transfusion and you could provide protection for a month or two. That if you knew you could get this and not go to the hospital then I think people would return to the workplace, to what they normally do without fear.”
TrialSite has closely followed the development of plasma as a COVID-19 treatment, and we will continue to watch this important story.