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.
“We are going to recruit patients who are at high risk for developing severe illness and may be most likely to benefit from a preventative treatment, such as patients over 50, those with heart disease, lung disease or diabetes and patients who are immunocompromised,” said Clifton Callaway, M.D., Ph.D., executive vice-chair of emergency medicine at the University of Pittsburgh.
“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 8 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 646,000 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.