Stony Brook Researchers are looking for those recovered from COVID-19 who can give convalescent serum for a potentially life-saving treatment.
STONY BROOK, NY, April 9, 2020 — A Stony Brook Medicine research study is underway to determine if blood plasma from people who have recovered from COVID-19 can help treat hospitalized patients with active COVID-19 infection. Stony Brook is seeking coronavirus survivors to donate blood plasma and researchers are collecting the convalescent serum to use in an experimental treatment strategy in those battling the disease.
Plasma, the liquid portion of the blood, which helps with clotting and supporting immunity, contains antibodies that can potentially be used to kill the virus. The U.S. Food and Drug Administration (FDA) began allowing healthcare providers to request the use of convalescent plasma in patients with serious or immediately life-threatening COVID-19 infections on March 27. Less than a week later, on April 2, Stony Brook University Hospital received FDA approval to offer the treatment to its patients through a randomized, controlled study (the gold standard in research) and is expected to enroll up to 500 patients from the Long Island area.
The study is led by 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. To maximize the opportunity of benefit, 80 percent of patients enrolled in the trial will receive the convalescent plasma. Normally, clinical trials have a 50/50 split; 50% with treatment and 50% in the control group.
“We are fast-tracking this large-scale clinical trial, as every second counts when seeking lifesaving treatment for these critically ill patients,” said Dr. Bennett-Guerrero. “The study will assess the safety and efficacy of convalescent plasma versus standard plasma in hospitalized adult patients with a confirmed COVID-19 diagnosis.”
Convalescent serum therapy is a century-old treatment that has been used in patients during the Spanish flu pandemic of 1918, the diphtheria epidemic in the U.S. in the 1920s, and more recently, the Ebola outbreak in 2014.
“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. This is especially important in the first several weeks of infection before one can develop high enough antibody levels to fight the virus.”
“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.”
Stony Brook Medicine is collaborating with Chembio Diagnostic Systems, a public company based on Long Island. Javan Esfandiari, Executive Vice President and Chief Science & Technology Officer who says Chembio is pleased that its unique and proprietary Dual Path Platform, referred to as DPP®, to separately and simultaneously detect and measure IgM and IgG antibodies, specifically to COVID-19, was the assay of choice for Stony Brook.
“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 Esfandiari. “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.”
A Journal of the American Medical Association study of the treatment shows promise from a team of Chinese scientists describing the use of convalescent plasma in five patients with COVID-19. Now, Stony Brook physician-researchers and researchers across the globe are looking to answer the question of whether this therapy can successfully help flatten the curve and save lives sooner than expected.
Note to readers: If you have recovered from COVID-19 and want to help others battling the disease by donating your blood plasma, please visit: https://www.stonybrookmedicine.edu/COVID_donateplasma. After filling out the online survey, potentially eligible people will be asked to participate in a screening visit at a Stony Brook Medicine facility. The screening visit will take approximately 30 minutes. You do not need to be a Stony Brook University Hospital patient to participate, but you must meet required criteria for plasma donation and have high levels of antibodies to the virus that causes COVID-19.