Clinical Trial Begins to See if Convalescent Plasma Can Treat COVID-19
BRONX, N.Y., April 29, 2020 /PRNewswire/ -- Montefiore Health System, Albert Einstein College of Medicine and NYU Langone have launched a new clinical trial to study if convalescent plasma—taken from people who have recovered from COVID-19—is effective in treating the disease.
The body's immune response to viral infections includes making molecules called antibodies. Antibodies can combat the infection and possibly prevent reinfection in people—and may be successful for helping people who are sick with COVID-19 fight the virus. This therapy, known as convalescent plasma therapy, has been deployed in viral outbreaks over the past century, and has shown promise in reducing the severity of illness and improving survival rates.
The randomized controlled trial will enroll 300 people with COVID-19 respiratory symptoms. Half of these individuals will receive plasma that contains antibodies to the SARS-CoV-2 coronavirus, while the remaining half will receive a placebo. Candidates for the clinical trial have had respiratory symptoms for less than a week, require some supplemental oxygen or have been in the hospital for less than four days.
"We created this study based on evidence from the pre-antibiotic era, but there has been no scientific proof it is really effective," said study co-leader Liise-anne Pirofski, M.D., chief of infectious diseases at Montefiore and Einstein and a leader of the national COVID-19 Convalescent Plasma Project.
Previous studies suggest that convalescent plasma may be helpful treatment for other coronaviruses, including SARS, but this trial aims to provide proof that it is effective for COVID-19 patients. Last month, Dr. Pirofski co-authored a widely cited viewpoint in the Journal of Clinical Investigation that championed the use of convalescent serum as a treatment for COVID-19.
Since the start of the pandemic, Montefiore has successfully treated and discharged approximately 4,000 severely ill COVID-19 patients from its hospitals. This presents an opportunity to get plasma from former patients and use these antibodies to treat a community disproportionally affected by COVID-19.
"Vaccines may not be available for more than a year. In the meantime, and given the lack of natural immunity and available vaccines, plasma therapy may help to provide the body what it needs to fight the infection," said co-lead study investigator, Mila Ortigoza, MD, PHD, an instructor in the departments of Medicine and Microbiology at NYU Langone Health. "Infections like the new coronavirus that jump into humans from animals are dangerous because we have no antibodies against them, so we hope to learn if supplying them can save lives."
The first Montefiore plasma donors came from Young Israel synagogue in New Rochelle. The community, which was home to one of the largest clusters of COVID-19 cases in the country, now represents a beacon of hope.
"To have so many people who have recovered from COVID-19 donate their plasma and make this research possible and potentially help people they have never met is an incredible celebration of the human spirit," said Dr. Pirofski. "We are overwhelmed by the generosity of recovered patients and are confident this trial will help us learn if convalescent plasma is effective against COVID-19."
About Montefiore Health System
Montefiore Health System is one of New York's premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 11 hospitals, including the Children's Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. For more information please visit www.montefiore.org. Follow us on Twitter and view us on Facebook and YouTube.
About Albert Einstein College of Medicine
Albert Einstein College of Medicine is one of the nation's premier centers for research, medical education and clinical investigation. During the 2019-20 academic year, Einstein is home to 724 M.D. students, 158 Ph.D. students, 106 students in the combined M.D./Ph.D. program, and 265 postdoctoral research fellows. The College of Medicine has more than 1,800 full-time faculty members located on the main campus and at its clinical affiliates. In 2019, Einstein received more than $178 million in awards from the National Institutes of Health (NIH). This includes the funding of major research centers at Einstein in aging, intellectual development disorders, diabetes, cancer, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States through Montefiore and an affiliation network involving hospitals and medical centers in the Bronx, Brooklyn and on Long Island. For more information, please visit www.einstein.yu.edu, read our blog, follow us on Twitter, like us on Facebook, and view us on YouTube.
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SOURCE Montefiore Health System; Albert Einstein College of Medicine