Two Bronx health systems have been awarded $4.3 million for what was described as a “promising treatment option” for coronavirus.
Issued by the National Institutes of Health, Montefiore and the Albert Einstein College of Medicine are now working on a “randomized, double-blind, placebo-controlled phase 2 clinical trial” regarding convalescent plasma, which had launched in April to treat COVID-19.
That grant is formally 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.”
“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., who is the chief of infectious diseases at both hospitals.
“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,” she added.
This convalescent therapy received FDA approval for investigational use in an open label protocol in the event that clinical trial information is not withheld from participants, which began with with hospitalized patients in late March.
However, physician-scientists at Einstein and Montefiore are said to have been pursuing the “gold standard” of a randomized clinical trial to determine if it can alleviate COVID-19 symptoms and reduce mortality rates since that time. Einstein, Montefiore, along with NYU Langone health systems began launching trials 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.
Currently, more than 180 people have been enrolled in the study, which is now expanding to other sites.
“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.
“Our junior faculty have all stepped up and risen to the occasion to fight COVID-19. It is remarkable to watch,” she added.
One of those junior faculty members, Hyun ah Yoon, M.D. 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. in addition to collaborative efforts with NYU Langone’s personnel.
The study team hopes to have results from the randomized convalescent trial by early 2021.