Trials to investigate the use of convalescent plasma in the treatment of hospitalized patients with coronavirus disease 2019 (COVID-19) are expanding enrollment, according to a statement released by the National Institutes of Health (NIH).
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients 18 years of age and older. Patients will be randomized 1:1 to receive either convalescent plasma or placebo. Outcomes will be assessed based on clinical improvement measures and resource needs (eg, ventilators). Trial results are anticipated as early as this fall.
The studies include the Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients trial, which was launched in April by NYU Langone Health in New York, with collaboration from the Albert Einstein College of Medicine and Yale University. To expand enrollment, NYU has partnered with The University of Texas Health Science Center at Houston and the University of Miami in Florida. Hospitalized patients with COVID-19 who are on supplemental oxygen, non-invasive ventilation or high-flow oxygen will be included. Clinical improvement will be assessed at 14 (primary end point) and 28 days (secondary end point) based on mortality, intensive care unit admission and patient antibody concentrations.
Additionally, the Passive Immunity Trial of Our Nation for COVID-19 began in April at Vanderbilt University Medical Center in Nashville, Tennessee. The trial includes patients with acute respiratory infection symptoms and laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection (SARS-CoV-2) who have been hospitalized or are in an emergency department with anticipated admission. Clinical improvement will be assessed at 15 days, along with ventilation use, supplemental oxygen use, acute kidney injury and cardiovascular events. The trial is expected to expand to an additional 50 sites across the Clinical and Translational Science Awards Program.
“The evidence on convalescent plasma as a treatment for severe cases of COVID-19 is promising but incomplete. We need to carry out rigorous randomized control clinical trials to determine how this therapy can improve outcomes,” said NIH Director Francis S. Collins, MD, PhD. “While the world waits for an effective vaccine, it is vital that we simultaneously expand the options for available treatments for those currently suffering from the worst effects of this disease.”
Recently, the Food and Drug Administration issued an Emergency Use Authorization (EUA) allowing the use of convalescent plasma in the treatment of hospitalized patients with COVID-19. The EUA was issued based on historical evidence indicating some effectiveness with convalescent plasma in previous outbreaks of respiratory viruses, as well as preclinical data.
For more information visit nih.gov.
NIH expands clinical trials to test convalescent plasma against COVID-19. https://www.nih.gov/news-events/news-releases/nih-expands-clinical-trials-test-convalescent-plasma-against-covid-19. Accessed September 22, 2020.