Johns Hopkins University is seeking Baltimore- and Annapolis-area residents who recently have been diagnosed with or exposed to the coronavirus for two clinical trials studying the effectiveness of blood plasma with virus antibodies in preventing and treating infections of COVID-19.
The nationwide studies have trials being conducted at Hopkins in Baltimore and at the Anne Arundel Medical Center.
A postexposure study, which looks at infection prevention, will feature 500 participants and is led by Dr. Shmuel Shoham, an infectious disease physician and associate professor of medicine at Hopkins.
A treatment study, seeking 600 participants, is led by Dr. David Sullivan, a professor of molecular microbiology and immunology at Hopkins. The Department of Defense is funding the studies.
“Everybody hopes that we wake up tomorrow morning and we’re in a COVID-free world, but that does not look like that’s going to be the reality,” Shoham said. “As the weather turns colder, people are inside more, people have more exposures, people have more infections, then we’re hoping that, if the study shows that this is something that works, that that will be another tool in the armamentarium against coronavirus.”
To be eligible to participate in the postexposure trial, an individual must have been exposed to the virus — meaning within 6 feet of an infected person for at least 15 minutes — within three days but not showing symptoms.
To be eligible to participate in the treatment study, an individual must have tested positive no more than five days prior, still be symptomatic but not hospitalized.
In both trials, half the participants will receive a transfusion of plasma with high levels of coronavirus antibodies, while the other half will be transfused with plasma with no antibodies as a control.
“We are confident that, biologically, this is an approach that has a high chance of working,” Shoham said. "The reason for that is antibodies do prevent the infection, and we think that giving plasma that has high-antibody against coronavirus is going to be effective, and we do know from the studies of in-patients that people that got treatment with high-antibody level and got it early had better outcomes than people that didn’t get plasma at all.
“A successful trial in my mind would be a trial that gives data that is useful for people regardless of the result. …," he continued. "Our job is really to collect information as well as possible, as safely as possible, and then try to interpret what the data shows in a way that’s helpful for people as they try to make a decision as to what they put in their body.”
Shoham noted that the process of using blood plasma as a prevention and treatment method is common, specifically noting its uses with hepatitis A, hepatitis B and rabies.
The plasma treatment ideally would be complementary to any vaccine that gets created, Shoham said.
“Not everybody may have access to the vaccine,” he said. “Not everybody may want the vaccine. Not everybody that gets the vaccine may respond to the vaccine, even if it’s a really good vaccine. It’s using a belt-and-suspenders approach.”
Those interested in participating in the study can call 888-506-1199 or visit www.covidplasmatrial.org to take an enrollment questionnaire, with the possibility that they will no longer be eligible should they wait too long after their exposure or diagnosis. Participants will be compensated.
Shoham said that clinical trials tend to skew toward certain demographics and that Hopkins is seeking participants from various backgrounds “so that the results are indicative of real life, not just one segment of the impacted people.”
Another challenge, Shoham said, is that those who were recently diagnosed or exposed to the virus might not be interested.
“Many people that have coronavirus infection or have been exposed, they just want to deal with having had that,” Shoham said. “Being part of a clinical trial isn’t on the top of the list of things that they had planned for their mid-September. We’re trying to really get the word out that this is an opportunity for people that have had this misfortune happen to them, either having the infection or being exposed, to help contribute, to give something, even in this difficult time.”