NIH: Expanding Trials for Convalescent Plasma

In recent months, convalescent plasma for the treatment of coronavirus 2019 (COVID-19) has seen its share of news and public debate within the medical science community and beyond.

In August, clinicians at Houston Methodist reported that transfusing critically ill COVID-19 patients with high antibody plasma early in their illness—within 72 hours after hospitalization proving most effective—reduced the mortality rate.

They transfused 316 patients, and a preliminary analysis showed a significant reduction (P = 0.047) in mortality within 28 days, specifically in patients transfused with an anti-spike protein receptor binding domain titer of ≥1:1350 within 72 hours of their admission with plasma.

Of the 316 transfused patients, 136 met a 28-day outcome and were matched to 251 non-transfused control COVID-19 patients.

During that same month, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for convalescent plasma in treating COVID-19. However, the FDA came under scrutiny when the agency reported a 35% lesser mortality rate for patients taking convalescent plasma. FDA Commissioner Steve Hahn, MD, took responsibility for the information and walked back the statistic after there was an outcry from the medical community.

Historically, convalescent plasma has been used for infectious disease treatment for over 100 years, and there are ongoing trials right now looking at the therapy for COVID-19. In late September, the National Institutes of Health (NIH) decided to expand 2 existing trials. These are randomized, placebo-controlled clinical trials to evaluate further convalescent plasma for hospitalized COVID-19 patients.

"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 Francis Collins, MD, PhD, director, NIH. "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 are receiving $48 million in support through Operation Warp Speed. Within NIH is the National Center for Advancing Translational Sciences (NCATS), and they will oversee the grant awards through its Clinical and Translational Science Awards (CTSA) Program research network. The CTSA's Trial Innovation Network (TIN) will play a key role in working to add study sites and enroll patients, including those from communities disproportionately affected by COVID-19.

Christopher Austin, MD, director, NCATS, says the center was developed to solve the problem of getting devices, diagnostics, and therapies to patients. They are involved in the “scientific and operational” aspects of translational research.

Austin spoke with Contagion® recently about the organization’s mission and the specifics of the 2 expanded trials for convalescent plasma.