HARTFORD, Conn. — Trinity Health Of New England announced the recent completion of its COVID-19 convalescent plasma phase-two clinical trial. The results have been published in the Infectious Diseases and Therapy Journal. Trinity Health Of New England is one of just four health systems in the U.S. to gain initial approval from the U.S. Food and Drug Administration to run the trial back in April.
“This is a wonderful accomplishment and a real attestation of what we are capable of achieving,” said Dr. Danyal Ibrahim, regional chief quality officer for Trinity Health Of New England, who served among a team of investigators of the study. “This publication will allow us to share our experience with convalescent plasma at a time when the conversation about safety and efficacy of this therapy remains alive and well in the U.S. and worldwide.”
The prospective, interventional study evaluated the safety and efficacy of convalescent plasma transfusion on critically ill COVID-19 patients. Convalescent plasma was obtained from recovered donors and administered to adult patients with either severe or critical COVID-19 illness. Of the 38 patients included in the analysis, 24 (63%) recovered and were discharged. Patients who received convalescent plasma early in the disease course (severe illness group) as compared to the patients that received convalescent plasma later in the disease progression (critical illness group) had significantly lower hospital mortality and shorter mean hospital length of stay.
“Our results suggest that convalescent plasma is safe and has the potential for positive impact on clinical outcomes, including recovery and survival, if given to patients early in the course of COVID-19,” added Dr. Latha Dulipsingh, who chairs the Institutional Review Board at Trinity Health Of New England and was also an investigator on the study.
Trinity Health Of New England began screening donors and treating COVID-19 patients in April, during Connecticut’s peak surge, under the framework of the FDA clinical trial. The organization’s four acute-care hospitals participated in the trial: Saint Francis Hospital, Saint Mary’s Hospital, Johnson Memorial Hospital in Connecticut, and Mercy Medical Center in Springfield. Saint Francis Hospital also participated in the Mayo Clinic Expanded Access Program for convalescent plasma, which helped to increase access to investigational convalescent plasma.