A team of Michigan Medicine, University of Pittsburgh, Medical University of South Carolina and Stanford Medicine researchers were recently awarded funds from the National Heart, Lung, and Blood Institute (NHLBI) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), totaling more than $7 million to collaboratively study the role of convalescent plasma in mitigating symptoms of COVID-19 in patients with mild illness and preventing the progression of the disease from mild to severe.
Convalescent plasma is derived from blood donated by persons who have already had COVID-19 and have recovered. Convalescent plasma contains antibodies that can bind to the virus that causes COVID-19 and neutralize it. Currently, convalescent plasma can be given as a treatment for patients in the hospital with severe or life-threatening COVID-19, a process called passive immunization.
Conducted as part of the NHLBI Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) initiative, the Clinical Trial of COVID-19 Convalescent Plasma of Outpatients (C3PO) aims to evaluate whether passive immunization can be a safe and efficacious therapy in preventing the progression from mild to severe or critical COVID-19 illness and to understand the immunologic impact of anti-SARS-CoV-2 antibodies on the disease after passive immunization.
“This trial will focus on patients with mild COVID-19 who have a high risk of developing severe illness, and who stand to benefit most if this approach works as an early treatment,” said Frederick Korley, M.D., Ph.D., an associate professor of emergency medicine at the University of Michigan and one of the principal investigators on the C3PO study. “This includes patients over age 50, those with heart disease, lung disease or diabetes and patients who are immunocompromised.”
“We think that convalescent plasma has the best chance of being effective if used when patients are just starting to show symptoms in order to decrease viral replication and the resulting severe inflammatory response that can be so damaging,” said Simone Glynn, M.D.,M.P.H., chief of the NHLBI’s Blood Epidemiology and Clinical Therapeutics branch. “What we want to find out is whether this plasma is effective enough to keep these at-risk patients from progressing to a point where they need hospitalization.”
According to the World Health Organization, more than 16 million people worldwide have been diagnosed with COVID-19, the respiratory illness caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), and more than 650,000 have died from the disease.
C3PO will study 600 COVID-19 patients at 50 U.S. medical centers who present to the emergency department with mild illness.
This research will be funded by the National Heart, Lung, and Blood Institute (NHLBI) and the Biomedical Advance Research and Development Authority (BARDA) as a sub award under the NHLBI Other Transaction award 1OT2HL156812-01.
The study is being coordinated through the SIREN Emergency Clinical Trials Network, whose Clinical Coordinating Center is located in the Michigan Medicine Department of Emergency Medicine. Full information on the trial is available on the SIREN site.