Nearly 300 Long Islanders struggling to recover from the coronavirus have been infused with plasma donated by individuals who have recovered from the potentially deadly virus as part of experimental treatments underway at three hospital systems across the region.
Scientists from Stony Brook University’s Renaissance School of Medicine, Northwell Health's Feinstein Institutes for Medical Research and Catholic Health Services are seeking to determine if the antibodies in plasma from recovering COVID-19 patients can help stop the infection in people who are still battling the virus.
Dr. Jason M. Golbin, Catholic Health's senior vice president and chief quality officer, said he is "cautiously optimistic" about the treatment but concedes it will be months before they can determine if it's safe and effective. To date, Catholic Health has conducted 140 convalescent plasma transfusions at its six Long Island hospitals.
"We don't know if it's going to help or not," Golbin said. "We don't know if it's going to be that so-called magic bullet. I think it's way too early to make any sort of prediction without appropriate data. One of the challenges in the treatment of COVID-19 is that we don't have a proven treatment. So this affords us another tool that we can use in this fight."
Potential plasma donors undergo the same screening and testing protocols typically used for blood donations.
Donors, who must have previously tested positive for COVID-19 but be free of symptoms for 14 days, start by completing a health questionnaire and then have their blood taken to determine if they have high enough COVID-antibody levels to continue in the process.
People who make the cut will be allowed to donate, a 45-minute process in which the plasma is removed and the red blood cells and platelets are returned to the donor’s body. One session could potentially yield enough plasma to treat two patients, experts said.
To be eligible to receive an infusion, patients must have a documented COVID-19 infection and be hospitalized for 14 days or less, officials said.
Three area hospital systems — Catholic Health, Northwell and Mount Sinai in Manhattan — are among 2,000 sites across the country participating in the "Convalescent Plasma Expanded Access Program," sponsored by the Mayo Clinic in Minnesota.
Stony Brook is conducting a clinical trial unaffiliated with Mayo and with different protocols and standards.
In Mayo's program, all COVID-positive patients would receive convalescent plasma without a control group getting a placebo. Stony Brook describes its program as a randomized double-blind clinical trial in which 400 participants receive convalescent plasma and another 100 receive standard plasma to see if they would respond differently.
"We believe that's the only way you can rigorously assess for safety and efficacy," said Dr. Elliott Bennett-Guerrero, vice chairman of clinical research in the Department of Anesthesiology at Stony Brook's Renaissance School, who is leading the study. "We like our design because we hope we can help a lot of patients but at the same time learn if it is safe and effective."
Stony Brook, which began enrolling patients in their protocol April 17, has screened nearly 200 donors with about 40 percent having high antibody levels, Bennett-Guerrero said. Thus far, 30 individuals have donated, or are scheduled to donate in the coming days, while officials expect to eventually ramp up to 20 infusions per day.
"While there is tremendous hope that convalescent plasma may be beneficial … it's very possible that it will not be effective at all," Bennett-Guerrero said. "We just don't know. And unless we do rigorous trials with a controlled group, there is just no way of knowing."
Mayo spokesman Robert Nellis said their program, which is under the auspices of the Food and Drug Administration, is not a clinical trial. In total, 1,726 patients in the Mayo program have been infused with convalescent plasma.
"While we are learning more as the program continues and expands daily, the goal was to accelerate a potential treatment, albeit experimental," Nellis said.
Feinstein initiated its program less than two weeks ago at six Northwell hospitals, with three more set to begin participating in the coming days. More than 250 donors have been screened and 110 COVID-positive patients have received transfusions, officials said.
“Convalescent plasma is interesting but has not been validated in a controlled clinical trial," said Feinstein president and chief executive Dr. Kevin Tracey. "Randomized controlled trials are needed to provide sufficient scientific knowledge on which the medical community can establish and find lasting cures.”
Mount Sinai began its program March 28, one of the first in the country to infuse convalescent plasma, said spokeswoman Elizabeth Dowling.
Roughly 7,000 people have been screened by Mount Sinai, with more than half identified as high-antibody producers and more than 160 receiving infusions, Dowling said.
Potential convalescent plasma donors are urged to fill out online surveys to see if they meet the criteria:
Stony Brook University: stonybrookmedicine.edu/COVID_donateplasma
Catholic Health Services: nybc.org/donate-blood/covid-19-and-blood-donation-copy/convalescent-plasma/