The National Institutes of Health (NIH) today announced it is expanding enrollment in two existing clinical trials to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19.
“Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19,” noted the NIH statement.
On Aug. 23, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for convalescent plasma therapy to treat COVID-19. The EUA was issued under a cloud of public pressure from the White House and a public relations debacle when the head of the FDA grossly overstated beneficial endpoints of related clinical trial data (and was subsequently forced to retracted his statement).
An NIH expert panel was convened to assess available data on convalescent plasma therapy and determined there’s insufficient data that the treatment makes any difference in the 7-day survival for patients with COVID-19.
“There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19,” the panel said in a statement.
“We need to carry out rigorous randomized control clinical trials to determine how this therapy can improve outcomes,” said NIH Director Francis S. Collins, M.D., Ph.D. “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.”
The trials expect to enroll hospitalized patients across the country at academic and community-based hospitals. Participants will be randomly assigned to receive the treatment or a placebo. Outcomes will be compared with respect to clinical improvement measures and resource needs, such as ventilators. Both trials currently are enrolling participants and anticipate results as early as this fall.
The trials are receiving $48 million in support through Operation Warp Speed (OWS), a collaborative initiative across federal agencies to advance the development, manufacturing and distribution of COVID‑19 vaccines, therapeutics and diagnostics.
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 in New York, with collaboration from the Albert Einstein College of Medicine and Yale University, New Haven, Connecticut, and with funding from NCATS. 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 to enroll participants at sites in these states.
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 also will be evaluating outcomes based on mortality, intensive care unit admission and patient antibody concentrations. Additional information about this study and participation is available at ClinicalTrials.gov under study identifier NCT04364737.
The 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, Tennessee, 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. Additional information about this study and participation is available at ClinicalTrials.gov under study identifier NCT04362176.