Upstate seeks recovered COVID-19 patients for emergency clinical trial
Upstate Medical University is seeking recovered COVID-19 test positive patients to donate plasma in an emergency clinical trial to help treat other severely ill patients battling the disease.
The project is part of the National COVID-19 Convalescent Plasma Project, which the Food and Drug Administration has approved as an Emergency Investigational New Drug (EIND). The theory is that people who have recovered from COVID-19 have developed the antibodies against the disease. Those antibodies could then be given to a currently infected person to lessen symptoms and speed recovery, said Timothy Endy, MD, MPH, professor and chair of microbiology and immunology at Upstate and Dr. Stephen Thomas MD, Chief of Infectious Disease and Leader of COVID-19 preparations for Upstate University Hospital.
UPSTATE IS IMMEDIATELY SEEKING VOLUNTEERS FOR THIS PROJECT: If you are 18 years or older, have tested positive for COVID-19 and are now 14 days out from your last symptom, please call Upstate Clinical Trials at 315-464-9869 to arrange a screening appointment.
Upstate is working with the American Red Cross to create the donation process. The process will involve a screening with Upstate including another COVID-19 test. After a negative test result, Upstate will schedule the plasma donation with the Red Cross. Once the plasma has been drawn, the Red Cross will screen it for other infectious diseases. That process can take several days but the first available plasma in this clinical trial could be available as soon as next week.
The pool of potential local plasma donors for the project should grow as those diagnosed continue to recover, Endy said. Current potential donors were likely diagnosed in early March, he said.
Plasma donation is safe for patients because they get to keep all of their “good cells,” Endy said and anecdotally, doctors are seeing only positive results from patients who are treated with convalescent plasma.
“The scientific premise is sound that antibodies can reduce symptoms and hopefully the severity of COVID-19,” Endy said. “The unknown with this type of product is currently we don’t know how much antibody we’re actually getting from recovered patients and that’s a question that needs to be answered and we’re hoping to do that. But the risk of getting a unit of plasma, which we do all the time for people who are post-surgical or in need of volume, is very low for any serious side effects and the potential benefit could be great.”
Upstate’s participation in the treatment trial was sparked during a teleconference conversation via Project ECHO Saturday morning among doctors from Upstate and in Wuhan, China. Doctors in Wuhan said they had seen improvements in the severity of COVID-19 symptoms in patients that had received convalescent plasma, Thomas said.
“It’s currently all anecdotal. There haven’t been any controlled studies yet but we hope that will change as we get more information,” he said.
Doctors at Upstate will collect data and blood samples with informed consent from patients who receive the plasma. That information can be used for later study but for now, the project is considered an emergency use therapeutic and only a treatment, not a study.
“It’s a good thing to do for what we’re dealing with right now. If we can stop the progression of the disease from having to have someone go onto a ventilator by giving convalescent plasma, that would be a huge impact,” Endy said. “If we could reduce people’s hospital days by three days that would be a huge impact, too.”
Upstate intends to be the regional resource for the project for any severely ill COVID-19 patients, Thomas said. He stressed that the donation and the transfusion of plasma is safe for the donor and the patient. Endy and Thomas are hopeful the community will respond generously.
“There’s so much public attention on this now and I hope that people who are feeling better and have survived this would really want to help other people,” Endy said.