Trinity Health Gets FDA Approval to Test Blood-plasma Therapy for COVID-19 Patients
HARTFORD, Conn. — The U.S. Food and Drug Administration approved a clinical trial that will allow Trinity Health Of New England to conduct a study to test a therapy for COVID-19 that uses plasma from recovering patients. Trinity Health Of New England is one of only four healthcare systems, including Johns Hopkins and the Mayo Clinic, that received FDA approval for this clinical trial.
“The basic premise of this study is to utilize antibodies from patients who have recovered from COVID-19 and inject them into those who are critically ill and on ventilator support,” said Dr. Syed Hussain, chief clinical officer, Trinity Health Of New England. “We are committed to fighting this pandemic.”
The prospective interventional study evaluates the safety and efficacy of using convalescent plasma transfusion to critically ill patients with COVID-19. One study from China reported in the Journal of American Medicine showed that five critically ill COVID-19 patients on ventilators significantly improved after treatment with convalescent plasma. Eventually, three of those patients were discharged home.
“Thousands of people across the country are sick with COVID-19, and currently there are no vaccines and or proven therapies to combat this novel coronavirus,” said Dr. Danyal Ibrahim, regional chief quality officer for Trinity Health Of New England. “However, plasma from recovered COVID-19 patients has the promise to be lifesaving, especially for the most critically ill.”
Added Dr. Latha Dulipsingh, who chairs the Institutional Review Board at Trinity Health Of New England, “our ability to conduct this trial will help us learn about the safety and efficacy of convalescent plasma in the treatment of COVID-19.” Ibrahim and Dulipsingh are the investigators on this study.
“Trinity Health Of New England is committed to being a transforming, healing presence,” said Dr. Reggy Eadie, president and CEO, Trinity Health Of New England. “This is one of many measures we are taking to ensure the health and safety of our patients, colleagues, and communities.”