Stony Brook Medicine is looking for Coronavirus survivors who would like to donate their blood plasma to a research study that is focusing on whether blood plasma from people who have recovered can aid in treating hospitalized patients with an active COVID-19 infection.
Elliott Bennett-Guerrero, MD, Medical Director of Perioperative Quality and Patient Safety and Professor and Vice Chair of Clinical Research and Innovation in the Renaissance School of Medicine Department of Anesthesiology, is spearheading the study.
“We are fast-tracking this large-scale clinical trial, as every second counts when seeking lifesaving treatment for these critically ill patients,” Dr. Bennett-Guerrero stated. “The study will assess the safety and efficacy of convalescent plasma versus standard plasma in hospitalized adult patients with a confirmed COVID-19 diagnosis.”
Plasma, which is the liquid section of the blood, aids with clotting and supporting immunity. It encompasses antibodies that may potentially be utilized to kill the virus. On March 27, the U.S. Food and Drug Administration (FDA) authorized healthcare providers’ petition to use convalescent plasma in patients with critical or life-threatening COVID-19 infections. Stony Brook University Hospital received FDA approval to provide the treatment less than a week later, on April 2. The Hospital expects to enlist up to 500 patients from the Long Island area.
“Everyone at Stony Brook is laser focused on identifying every pathway possible to help change the course of this devastating virus,” said Kenneth Kaushansky, MD, MACP, Senior Vice President, Health Sciences and Dean, Renaissance School of Medicine at Stony Brook University. “Having a network of physician-scientists in place allows us to contribute on both a local and global scale to accelerate the fight against COVID-19 and save lives.”
While normally in clinical trials there is a 50/50 split (50 percent with treatment and 50 percent in the control group), but Stony Brook Medicine is hoping to maximize the results by having 80 percent of patients enrolled in the trial receive the convalescent plasma.
“Transferring this antibody-rich plasma into someone who is still fighting the disease may give that person the immune power to recover from the disease,” Stony Brook Medicine notes. “This is especially important in the first several weeks of infection before one can develop high enough antibody levels to fight the virus.”
Convalescent serum therapy, a century-old treatment, has been utilized in the past during the Spanish flu pandemic (1918), the diphtheria epidemic in the U.S. (1920s), as well as the Ebola outbreak (2014).
Stony Brook Medicine has partnered with Chembio Diagnostic Systems. The Long Island-based company’s proprietary Dual Path Platform (DPP®) will be employed to “separately and simultaneously detect and measure IgM and IgG antibodies, specifically to COVID-19.”
“Our unique patented technology uses one of our two analyzers (the MR1 and MR2) produced by Chembio, to read the test results for both IgM and IgG from finger stick blood in 15 minutes and give a numerical result related to the amount of antibody in the sample,” said Javan Esfandiari, Chembio Executive Vice President and Chief Science & Technology Officer. “This takes away the individual subjectivity of results and increases the sensitivity and specificity of the test. Chembio has now received authorization to market and sell the DPP COVID-19 IgM and IgG assay system in the US through the FDA notification process.”
Those that have recovered from COVID-19 and would like to donate their blood plasma should visit stonybrookmedicine.edu to fill out an online survey. If selected, patients would be asked to attend a screening visit, which would take approximately 30 minutes, at a Stony Brook Medicine facility. Coronavirus survivors do not need to be a Stony Brook University Hospital patient to participate, but they must meet the required criteria for plasma donation, as well as possess elevated levels of antibodies to the virus that causes COVID-19.