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Nearly 300 Long Islanders who were struggling to recover from the coronavirus were infused with donated plasma by individuals who recovered from the potentially lethal virus as part of ongoing experimental treatment in three hospital systems in the region.
Scientists at the Renaissance School of Medicine at Stony Brook University, the Feinstein Institute for Medical Research, and Catholic Health Services at Northwell Health are investigating whether antibodies in plasma from recovery of COVID-19 patients can help stop the infection in people who are still fighting the virus.
Dr. Jason M. Golbin, senior vice president and quality manager for Catholic Health, said he was “cautiously optimistic” about the treatment, but conceded that it would take months before he could determine if he was safe and effective. To date, Catholic Health has performed 140 convalescent plasma transfusions at its six hospitals on Long Island.
“We don’t know if it will help or not,” said Golbin. “We don’t know if it will be this so-called magic bullet. I think it is far too early to make some kind of prediction without proper data. One of the challenges of COVID-19 treatment is that we don’t have a proven treatment. So this gives us another tool that we can use in this fight. “
Potential plasma donors undergo the same screening and testing protocols generally used for blood donation.
Donors, who must have previously tested positive for COVID-19 but be symptom-free for 14 days, begin by completing a health questionnaire, then get blood drawn to determine if they have sufficient COVID antibody levels. raised to continue in the process.
The people making the cut will be allowed to donate, a 45-minute process in which the plasma is taken and the red blood cells and platelets are returned to the donor’s body. One session could potentially produce enough plasma to treat two patients, experts said.
To be eligible for an infusion, patients must have a documented COVID-19 infection and be hospitalized for 14 days or less, officials said.
Three local hospital systems – Catholic Health, Northwell and Mount Sinai in Manhattan – are among 2,000 sites in the country participating in the Convalescent Plasma Expanded Access Program, sponsored by the Mayo Clinic in Minnesota.
Stony Brook is conducting a clinical trial not affiliated with Mayo and with different protocols and standards.
In the Mayo program, all COVID-positive patients would receive convalescent plasma without a control group receiving a placebo. Stony Brook describes his 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 think it’s the only way to rigorously assess safety and effectiveness,” said Dr. Elliott Bennett-Guerrero, vice president of clinical research in the Department of Anesthesiology at Stony Brook’s Renaissance School , who directs the study. “We love our design because we hope to be able to help a lot of patients but at the same time know if it is safe and effective. “
Stony Brook, who began enrolling patients in his protocol on April 17, has screened nearly 200 donors, about 40% of whom have high antibody levels, said Bennett-Guerrero. So far, 30 people have donated, or are expected to donate in the coming days, while authorities expect to eventually increase to 20 infusions per day.
“While there is great hope that convalescent plasma will be beneficial … it is quite possible that it will not be effective at all,” said Bennett-Guerrero. “We just don’t know. And unless you do rigorous testing with a controlled group, there is simply no way of knowing. “
Mayo spokesman Robert Nellis said their program, under the auspices of the Food and Drug Administration, is not a clinical trial. A total of 1,726 patients in the Mayo program received a convalescent plasma infusion.
“As we learn more as the program continues and grows daily, the goal has been to speed up potential, albeit experimental, treatment,” said Nellis.
Feinstein launched his program less than two weeks ago in six hospitals in Northwell, and three more are expected to start 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 CEO, Dr. Kevin Tracey. “Randomized controlled trials are necessary to provide sufficient scientific knowledge on which the medical community can establish and find lasting remedies. . “
Mount Sinai began its program on March 28, one of the first in the country to infuse convalescent plasma, said spokeswoman Elizabeth Dowling.
About 7,000 people have been screened by Mount Sinai, more than half of whom have been identified as high antibody producers and more than 160 have received infusions, said Dowling.