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The Potential of Plasma and Passive Immunity

Posted by on Monday, October 5, 2020 in Fall 2020, Related Content .

In August VUMC was awarded a one-year, $34 million grant by the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, to conduct a nationwide study of “convalescent plasma” as a treatment for COVID-19.

The study, called the Passive Immunity Trial for Our Nation (PassItOn), will test whether infusions of plasma, the liquid part of blood collected from COVID-19 survivors and which contains antibodies against the SARS-CoV-2 virus, can help other hospitalized patients with COVID-19.

Convalescent plasma, one form of a treatment called passive immunization, has been used for more than a century to treat a wide variety of infections, including pneumonia, meningitis, measles, influenza and Ebola, but without clear evidence of safety and effectiveness.

Convalescent plasma from COVID-19 survivors currently is being used throughout the country to treat people who are seriously ill with COVID-19. However, to date there have been only two randomized, controlled clinical trials and both were ended early without definitive results.

VUMC began collecting plasma donations from people who had recovered from COVID-19 in April, thanks to support from the Dolly Parton COVID-19 Research Fund. The federal grant enabled the clinical trial to expand to 51 sites across the country.

The goal is to recruit 1,000 participants by the end of October and report results by November.

“As doctors, we continue to lack adequate therapies to treat patients with COVID-19,” said Todd Rice, MD, MSc, who is co-leading the PassItOn trial with Wesley Self, MD, MPH.

“Convalescent plasma could offer promise, but we must answer this question rigorously in a randomized trial, especially for the sickest patients at increased risk of mortality,” said Rice, associate professor of Medicine and director of VUMC’s Medical Intensive Care Unit.

“Our goal is to rapidly complete a scientifically rigorous, randomized, placebo-controlled trial of anti-SARS-2 convalescent plasma to inform clinical practice,” said Self, associate professor and vice chair for Research in the Department of Emergency Medicine. “We believe VUMC is ideally positioned to lead this study and help answer this critical question.”

NCATS is supporting the clinical trials through its Clinical and Translational Science Awards (CTSA) Program and under award number UL1TR002243. VICTR, which is supported by a CTSA, will oversee the PassItOn trial. The Vanderbilt Coordinating Center will manage all sites participating in the trial nationwide.

VICTR director Gordon Bernard, MD, and Consuelo Wilkins, MD, MSCI, who are co-principal investigators of VUMC’s CTSA, also will serve as co-principal investigators of the PassItOn study.

Unlike many of the ongoing clinical trials in COVID-19, PassItOn has few exclusion criteria and will include pregnant women and the elderly, patients with chronic heart, liver or kidney disease as well as those who are immunocompromised.

The plasma will be collected and distributed to sites through VUMC’s blood donation center partner, Blood Assurance, a nonprofit regional blood center based in Chattanooga. Hospitalized COVID-19 patients enrolled in the trial will be randomly selected to receive either infusions of plasma containing anti-SARS-CoV-2-antibodies or “placebo” infusions.

If the use of convalescent plasma is proven to be of likely benefit to patients with COVID-19, “it could immediately change clinical practice,” said Bernard, the Melinda Bass Owen Professor of Medicine and VUMC’s Executive Vice President for Research.