Researchers at Wayne State University are studying the potential benefits of using convalescent blood plasma from COVID-19-infected donors on exposed and diagnosed patients, to see if antibodies can help fight SARS-CoV-2, the novel coronavirus which causes COVID-19.
Johns Hopkins University is sponsoring the outpatient clinical trials, which are being conducted at WSU, along with 23 other sites, according to JHU. Researchers are still in the preliminary stages of the trials and expect to recruit at least 25 to 30 people sick with COVID-19 to receive plasma.
Convalescent plasma is the liquid portion of the blood that is collected from people who have recovered from COVID-19, according to the study. After fighting COVID-19, patients’ plasma may contain high levels of antibodies that could help others fight the disease.
The American Red Cross collects the plasma at WSU’s donation sites and is currently seeking blood donors, said Dr. James Paxton, WSU School of Medicine Department of Emergency Medicine assistant professor and clinical scholar, and principal investigator for the plasma trials. The study is also in need of people willing to receive a trial treatment of convalescent plasma therapy. The results of the study will not be released until they reach the minimum number of donors.
Clinical Trial: COVID-19 Exposed, referred to by researchers as CSSC-01, is seeking to discover if the plasma can protect someone who has been exposed and is at a continued high risk of being infected with the virus, according to JHU. This could include a parent caring for a sick child or a healthcare worker not wearing personal protective equipment.
"We want to see whether we can stop them from getting the infection,” Paxton said. “They're still going to be around that person, so they're still going to be continuously exposed, but can we stop them from developing the disease by giving them plasma against COVID?”
Clinical Trial: COVID-19 Positive or CSSC-04 is seeking individuals who are confirmed to have COVID-19 and have at least one symptom, according to JHU. The goal is to see if the antibodies can help combat the disease in its early stages to prevent it from worsening.
Plasma infusion is simple and patients would not have to return to receive a second infusion, Paxton said.
"The infusion itself takes less than an hour, but there's a lot of details that have to happen,” Paxton said. “So, we have to do some blood tests on the person who's interested in being in the study and more."
WSU is also conducting The Clinical Trial of COVID-19 Convalescent Plasma in Outpatients, sponsored by the Strategies to Innovate Emergency Care Clinical Trials Network. The C3PO trial studies passive antibody therapy, which is similar to both CSSC trials, Paxton said. The main difference is that participants have to follow-up with doctors.
“The differences relate to the follow up because we have a different schedule. We limit ones who have confirmed COVID cases to have their first ten days of follow up done by phone," Paxton said.
Even though it may take time to see results, the trials are based on previous knowledge of diseases similar to COVID-19, said Dr. Brian O'Neil, WSU Department of Emergency Medicine Munuswamy Dayanandan endowed chair and the principal investigator of the C3PO study.
"We did this in the Spanish flu. It's not really high tech,” O'Neil said. “This is something that they've done for a long time, but I think the impact will be big for the patients themselves.”
Even with a vaccine, some people are going to get COVID-19, Paxton said, and other treatments will be needed. Monoclonal antibody drugs are designed to “restore, enhance or mimic” an immune system’s attack, according to the Mayo Clinic.
Paxton said these antibody drugs can be limited and expensive.
“So this (convalescent plasma) maybe is a less expensive and more available option for people going forward with COVID if it's proven to be effective,” he said.
With the current knowledge of COVID-19 and how it attacks the immune system, O'Neil said it is important to seek medical treatment as soon as symptoms are exhibited. Although patients’ immune systems may be intact, they could still face serious effects.
For the CSSC trials, a high concentration of antibodies is needed in the plasma in order to donate, according to JHU. High amounts of antibodies are seen in people who had a fairly severe case of COVID-19, Paxton said. However, 30% of documented COVID-19 patients are not making enough antibodies to qualify for plasma donation.
“These are people who probably had some rough symptoms for a week or two and that's why they developed so much antibody in their plasma versus the ones who unfortunately couldn't have their plasma used for this study," Paxton said.
Other COVID-19 studies taking place at WSU include student-conducted research. Due to a recent increase in cases, first and second-year medical students are not able to participate in any clinical work, said Gina Polsinelli, a second-year medical student.
"At the medical school, they've done a pretty good job at protecting us from any situations that are extraneous and unneeded. So I think they've done a good job in light of all of the research and the government's new orders," she said.
Polsinelli is currently researching the effects of COVID-19 on the heart by studying data, she said.
"As a future doctor, in general there's a great sense of responsibility,” Polsinelli said. “We're fortunate enough to be able to understand this data and work on this data… I feel like you have to use it for the betterment of society."
To participate in the plasma trials, visit covidplasmatrial.org. Participants will be compensated.
The trials at WSU are being conducted at 6071 W. Outer Drive, Lourdes Bldg., 4th Floor, L-464 and 4201 St. Antoine.
Irving Mejia-Hilario is sports editor for The South End. He can be reached at firstname.lastname@example.org.
Cover photo provided by Thomas Mazzocco, research assistant at the Wayne State University School of Medicine.