BATON ROUGE, La. (The West Side Journal) – Our Lady of the Lake announced its selection as one of only 51 sites to participate in a one-year nationwide study led by Vanderbilt University Medical Center of convalescent plasma as a treatment for COVID-19. The study, called Passive Immunity Trial for Our Nation (PassItOn), is funded by a $34-million grant provided by the National Center for Advancing Translational Sciences, part of the National Institutes of Health.
“Our Lady of the Lake has cared for more than 1,500 COVID-19 patients since the pandemic began and we remain committed to leading in best practices and rigorous scientific evaluation of therapies,” said Vince Cataldo, MD, primary investigator for PassItOn at Our Lady of the Lake. “We’ve seen promising results with the use of convalescent plasma and this nationwide study will help definitively determine whether or not convalescent plasma is a proven therapy that can save lives.”
Convalescent plasma from recovered COVID-19 is currently being used throughout the country to treat people who are seriously ill with COVID-19. However, to date there have been only two randomized, controlled clinical trials and both were ended early without definitive results.
Our Lady of the Lake’s medical director of research, Hollis O’Neal, MD, and medical director of patient quality and safety, Christopher Thomas, MD, are co-investigators for PassItOn.
“We are excited to partner with Vanderbilt University Medical Center and the National Institute of Health on this study,” said Dr. O’Neal. “As a nationally recognized academic medical center, research is one of our top priorities and we’re proud to be at the forefront of trials that will save lives and help our medical colleagues continue to fight COVID-19.”
The randomized, controlled trial will test whether infusions of convalescent plasma, the liquid part of blood collected from those recovered COVID-19 individuals, can help other hospitalized patients with COVID-19. This type of plasma contains antibodies against SARS-CoV-2, the virus that causes COVID-19.
“We are months into this pandemic and we are still figuring out what works and what doesn’t. This study is important in identifying if our resources and attention are focused on the right therapies for COVID-19,” said Dr. Thomas. “Our fight against COVID-19 isn’t over and we must focus on proven treatments that will help patients recover.”
Convalescent plasma, one form of a treatment called passive immunization, has been used for more than a century to treat a wide variety of infections, including pneumonia, meningitis, measles, influenza and Ebola but without clear evidence of safety and effectiveness.
Todd Rice, MD, MSc, and Wesley Self, MD, MPH, at Vanderbilt University Medical Center will lead the study, which will recruit 1,000 participants in approximately 51 sites across the country. The goal is to complete enrollment by October 31, and report results by November.
PassItOn is one of two clinical trials of convalescent plasma funded through Operation Warp Speed, a collaborative initiative across federal agencies to advance development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.
People who have recovered from COVID-19 and agree to participate in the study can make up to four plasma donations. Each plasma sample will be tested for the presence of antibodies against SARS-CoV-2. Only those samples with relatively high amounts of neutralizing antibodies will be used in the study.
Hospitalized COVID-19 patients randomly will be given either infusions of plasma containing anti-SARS-CoV-2-antibodies or “placebo” infusions to determine what impact, if any, the antibodies have on the course of their illness.
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