August 18, 2020—(BRONX, NY)—As the search for COVID-19 therapies continues, convalescent plasma—distilled from the blood of people who have recovered from COVID-19—has emerged as a promising treatment option. Now, the National Institutes of Health has awarded Albert Einstein College of Medicine and Montefiore a $4.3 million grant to support a randomized, double-blind, placebo-controlled phase 2 clinical trial that launched in April to evaluate the efficacy of convalescent plasma to treat COVID-19.
“Convalescent plasma has a long history of improving symptoms and decreasing mortality associated with pandemic diseases, dating back to meningitis at the beginning of the 20th century,” said trial principal investigator at Einstein and Montefiore, Liise-anne Pirofski, M.D., chief of infectious diseases at Montefiore and Einstein, professor of medicine, and of microbiology and immunology at Einstein, and a member of the leadership group of the national COVID-19 Convalescent Plasma Project. “Historically, studies of convalescent plasma for pandemic diseases have been small and the results anecdotal—we are hopeful that our randomized controlled trial will provide a definite answer on its efficacy for COVID-19.”
Convalescent therapy received FDA approval for investigational use in an open label protocol (when clinical trial information is not withheld from participants) for hospitalized patients in late March—but physician-scientists at Einstein and Montefiore have been pursuing the “gold standard” of a randomized clinical trial to determine if it can alleviate COVID-19 symptoms and reduce mortality rates.
Knowing there was no time to waste, Einstein, Montefiore, and NYU Langone swiftly launched the trial prior to securing federal funding. Study coordinators, pathologists, blood bank personnel, statisticians, regulatory specialists, clinicians, and research nurses quickly united to roll out the trial, which uses convalescent plasma and a placebo. To date, more than 180 people have been enrolled in the study, which is now expanding to other sites.
What makes this NIH grant unique compared to many others is that funding did not go directly to the principal investigators of the convalescent plasma trial, but rather to the Clinical and Translational Science Awards program, which in turn, funds the Block Institute for Clinical and Translational Research at Einstein and Montefiore (ICTR).
The ICTR, established in 2007, formalized the research partnership between Einstein and Montefiore and is designed to break down barriers that inhibit cross-disciplinary research among basic scientists, clinical researchers, and population health investigators. In addition, the ICTR provides a number of resources and training opportunities to junior faculty, like the Clinical Research Training Program (CRTP), a two-year master’s program which prepares clinicians for research careers.
“This is the beauty of working at an academic center: several of our faculty are a triple threat – they are physicians seeing patients, educators teaching students and colleagues, and researchers doing outstanding scientific investigation,” said Marla Keller, M.D., vice chair for research in the department of medicine at Einstein and Montefiore, principal investigator of the CTSA grant with Harry Shamoon, M.D., associate director of the ICTR, and PI of this new award. “Our junior faculty have all stepped up and risen to the occasion to fight COVID-19. It is remarkable to watch.” Dr. Keller is also professor of medicine and of obstetrics & gynecology and women’s health at Einstein and an ID specialist at Montefiore.
We are hopeful that our randomized controlled trial will provide a definite answer on its efficacy for COVID-19.
Liise-anne Pirofski, M.D.
Hyun ah Yoon, M.D., a junior faculty member and assistant professor at Einstein, began the CRTP in July, and is co-principal investigator on the convalescent plasma trial, working with other emerging leaders in infectious diseases, including Rachel M. Bartash, M.D.; Uzma Sarwar, M.D.; and Inessa Gendlina, M.D., Ph.D. Along with members of NYU Langone’s CTSA, they are collaborating across institutions and represent the next generation of infectious disease physician-researchers.
“We are tremendously excited to receive this NIH support for our urgent attempt to determine whether plasma from patients that have recovered from COVID-19 can save lives,” says co-lead study investigator, Mila Ortigoza, M.D., Ph.D., an instructor in the Departments of Medicine and Microbiology at NYU Langone Health. “Vaccines may not be available for some time, and plasma therapy may provide an important option in the meantime.”
Einstein-Montefiore and NYU are two of 60 CTSAs throughout the country. The study team hopes to have results from the randomized convalescent trial by early 2021.
The grant is titled “Convalescent Plasma to Limit Coronavirus Associated Complications: A Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-COV-2 Plasma to Placebo in COVID-19 Hospitalized Patients.”