The National Institutes of Health (NIH) is expanding enrollment in two randomized controlled trials to evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19, according to a press release.
Although evidence supporting its use in COVID-19 patients is limited, the U.S. Food and Drug Administration (FDA) already has approved the emergency use of convalescent plasma in patients who have severe or life-threatening COVID-19.
The government is providing $48 million to support the trials through Operation Warp Speed (OWS). The National Center for Advancing Translational Sciences (NCATS), part of NIH, will oversee the grant awards through its Clinical and Translational Science Awards (CTSA) Program research network. The CTSA's Trial Innovation Network (TIN) will play a key role in working to add study sites and enroll patients, including those from communities disproportionately affected by COVID-19.
One trial, called Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients, was launched in April by NYU Langone Health, NY, with collaboration from the Albert Einstein College of Medicine, NY, and Yale University, New Haven, CT. To increase enrollment in the trial, NYU is partnering with The University of Texas Health Science Center at Houston and the University of Miami in Florida.
With these additional sites, this trial expects to enroll approximately 1,000 hospitalized patients 18 years or older with respiratory symptoms of COVID-19. The trial is primarily assessing clinical improvement at 14 and 28 days and will be evaluating outcomes based on mortality, intensive care unit admission and patient antibody concentrations.
A second trial, called Passive Immunity Trial of Our Nation for COVID-19, also is expanding to enroll about 1,000 participants. Vanderbilt University Medical Center in Nashville, TN, which launched the trial in April, will have access to about 50 additional clinical trial sites across the CTSA Program. Participants are 18 years or older with acute respiratory infection symptoms and laboratory-confirmed SARS-CoV-2 infection; they may be hospitalized or in an emergency department and likely to be admitted. The trial primarily will assess clinical improvement at 15 days and also will evaluate ventilation use, supplemental oxygen use, acute kidney injury and cardiovascular events.
