The Data Coordination Unit (DCU) in the Department of Public Health Sciences at the Medical University of South Carolina will take on the role of Data Coordinating Center for a $7 million national trial studying the role of convalescent plasma in mitigating the symptoms of COVID-19 in patients with mild illness and preventing the progression of the disease from mild to severe.
The DCU and a team of University of Pittsburgh, Michigan Medicine, 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, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Convalescent plasma is derived from blood donated by persons who have already had COVID-19 and 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.
MUSC’s DCU, led by Valerie Durkalski-Mauldin, Ph.D., and Sharon Yeatts, Ph.D., will collaborate with the other institutions on the successful planning and coordination of the trial. The DCU will provide all statistical activities and data coordination using its internally developed and validated clinical trials management system, known as WebDCU, which the entire study team will use.
“Multicenter randomized clinical trials are needed to help identify safe and effective treatments for COVID-19. C3PO and other trials testing the efficacy of convalescent plasma will provide valuable information for the community. The DCU is excited to be part of this important collaboration,” Durkalski-Mauldin said.
C3PO will study 600 COVID-19 patients, at 50 U.S. medical centers, who present to emergency departments with mild illness. Clifton Callaway, M.D., Ph.D., executive vice chair of emergency medicine at the University of Pittsburgh, said researchers will recruit patients who are at high risk for developing severe illness and seem most likely to benefit from preventive treatment, such as people over 50; those with heart disease, lung disease or diabetes; or people who are immunocompromised.
“Beyond the initial public health strategies of containment and mitigation, MUSC is working in a collaborative approach to address emerging challenges in the management of COVID-19 patients using convalescent plasma, which if proven effective may reduce the burden in our population until a vaccine becomes available,” said Hermes Florez, M.D., Ph.D., chairman of the Department of Public Health Sciences at MUSC.
Half of recruited patients will receive a single dose of convalescent plasma. The other half will receive a saline placebo. The two groups will be compared on rates of hospital admission, death or seeking emergency or urgent care within 15 days of treatment.
“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., 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, 16.3 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.
In South Carolina, as of July 29, 85,423 people have been diagnosed with COVID-19 and 1,551 people have died from the disease, according to the S.C. Department of Health and Environmental Control.