Vanderbilt University Medical Center (VUMC) has been awarded a one-year, $34-million grant by the National Center for Advancing Translational Sciences, part of the National Institutes of Health, to conduct a nationwide study of "convalescent plasma" as a treatment for COVID-19.
The randomized, controlled trial will test whether infusions of plasma, the liquid part of blood collected from COVID-19 survivors, can help other hospitalized patients with COVID-19. The plasma contains antibodies against SARS-CoV-2, the virus that causes COVID-19.
Todd Rice, MD, MSc, and Wesley Self, MD, MPH, will lead the study, which will recruit 1,000 participants in approximately 51 sites across the country. The goal is to complete enrollment by October 31, and report results by November.
As doctors, we continue to lack adequate therapies to treat patients with COVID-19. 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."
Todd Rice, Associate Professor of Medicine and Director of VUMC's Medical Intensive Care Unit
In April VUMC began collecting plasma donations from people who had recovered from COVID-19 and to date has recruited more than 40 participants. The study, called Passive Immunity Trial for Our Nation (PassItOn), was launched thanks to support from the Dolly Parton COVID-19 Research Fund.
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.
"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."
PassItOn is one of two clinical trials of convalescent plasma funded through Operation Warp Speed, a collaborative initiative across federal agencies to advance development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. NYU Langone Health in New York City leads the other trial.
The National Center for Advancing Translational Sciences is supporting the clinical trials through its Clinical and Translational Science Awards (CTSA) Program and under award number UL1TR002243.
The CTSA-supported Vanderbilt Institute of Clinical and Translational Research (VICTR) will oversee the PassItOn trial and the Vanderbilt Coordinating Center, an expert Clinical and Data 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.
Nearly 30 sites so far have expressed interest in joining the PassItOn study. Ohio State University Medical Center is expected to be joining imminently. VUMC is focusing on sites in areas with high or rapidly rising numbers of COVID-19 cases and those which can quickly execute contractual agreements with VUMC.
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 non-profit regional blood center based in Chattanooga, Tennessee.
People who have recovered from COVID-19 and agree to participate in the study can make up to four plasma donations. Each plasma sample will be tested for the presence of antibodies against SARS-CoV-2. Only those samples with relatively high amounts of neutralizing antibodies will be used in the study.
Hospitalized COVID-19 patients randomly will be given either infusions of plasma containing anti-SARS-CoV-2-antibodies or "placebo" infusions to determine what impact, if any, the antibodies have on the course of their illness.
If the use of convalescent plasma is proven to be of likely benefit to patients with COVID-19, "it could immediately change clinical practice," Bernard said. To that end, VICTR's Dissemination Core is prepared to rapidly share the results of the study with patients and doctors around the country, he said.
Bernard is the Melinda Bass Owen Professor of Medicine and Executive Vice President for Research at VUMC. Wilkins is professor of Medicine and VUMC's Vice President for Health Equity. Rice is VICTR's Vice President for Clinical Trial Innovation and Operations.