Published by the Students of Johns Hopkins since 1896
October 29, 2020

Researchers prioritize wide and equitable recruitment for COVID-19 clinical trials

By MEDHA KALLEM | October 8, 2020

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COURTESY OF JOHNS HOPKINS UNIVERSITY 

Dr. Shmuel Shoham (pictured) and Dr. David Sullivan are currently recruiting for COVID-19 clinical trials.

The National COVID-19 Convalescent Plasma Project is a group of physicians seeking to understand the potential role of convalescent plasma in the treatment of COVID-19. Dr. Shmuel Shoham, an associate professor of medicine at Hopkins, and Dr. David Sullivan, a professor of molecular microbiology and immunology at the Hopkins Malaria Research Institute, are members of the group.

The team is investigating the effects of convalescent plasma for two different instances: early infection and postexposure. 

The early infection study is seeking 600 patients who have been infected with COVID-19 but are not hospitalized. This outpatient study is a randomized clinical trial; half of the participants are infused with high-antibody titer plasma, while the other half receive plasma without antibodies. 

In an interview with The News-Letter, Sullivan explained that high-antibody titer plasma are retrieved from people who have successfully recovered from the virus. Infusion involves transferring that plasma to people early in the course of their illness. 

The goal of this study is to understand whether plasma infusion can prevent progression of COVID-19 to a stage that requires hospitalization. 

“[We want] to validate that we can prevent people from going to the hospital by giving antibodies early in the disease course rather than waiting until later when they arrive at the hospital,” Sullivan said.

The postexposure prophylaxis study is also a randomized clinical trial seeking 500 patients who have been exposed to COVID-19 but have not yet tested positive for the disease. Patients will receive plasma with either a high antibody titer or no antibodies. The aim is to understand the role convalescent plasma plays in preventing an infection from occurring. 

The project has recruited investigators from 57 different participating institutions across the nation to conduct these trials.

Although this research began in July, the team has recently struggled to find patients who are willing to participate in their trials. 

In an interview with The News-Letter, Shoham said that finding participants for these trials has been more difficult than previous trials he’s worked with. There are simple logistical barriers — like the fact that patients are required to put in more effort to participate because these are outpatient trials and the patients are not already in the hospital. Additionally, many patients that are being tested for COVID-19 are not being seen at places that conduct clinical trials, and therefore they are not receiving information about available trials being conducted across the nation. 

Sullivan emphasized how a lack of familiarity with plasma and COVID-19 clinical trials are barriers. 

“A lot of people don't know about plasma or antibodies; they get confused with the vaccine,” Sullivan said. “People want to donate rather than receive plasma to be that part of the solution.”

A unique constraint with these trials is the short time frame in which people have to decide whether or not they want to be participants. According to Shoham, participation in a clinical trial is a big decision to make. People typically need much more time than a few days to process all of the implications of being in a trial as well as the emotional toll this time can take on a patient. 

“Oftentimes after they’ve been exposed or diagnosed people have to deal with the emotional issue of being diagnosed or exposed to coronavirus and all the issues surrounding that,” Shoham said. “Being involved in a clinical trial is one extra piece that’s just too much.” 

Participants are required to make a few visits over the course of 90 days to a hospital. They also have an initial screening visit where their blood type is tested. 

If they are participating in the postexposure study, they are also given a COVID-19 test to ensure they are not yet positive. This is then followed by an infusion visit and a series of visits for blood draws and nasal swabs. The data help determine the impact of the infused plasma on the development of infection and the period of time antibodies remain in the body. 

The team has recently hired a communications firm to increase efforts on spreading information regarding the trials. They are trying to spread general information through articles, media, advertisements and their new website that was launched in mid-September. The team is also focusing on increasing direct patient outreach.

“A physician calling and interacting with the patients is best, especially with COVID-19, to help to answer questions,” Sullivan explained. 

According to Shoham, using a wide variety of communications is important to reach people representing a large range of demographics. Doing so would enable the researchers to create a patient group that represents the demographics of the actual infected population. For example, the project has hired an individual in Baltimore who is working on increasing participation from the Spanish-speaking community. 

Despite the team’s efforts, Shoham explained that researchers are still concerned that not all members of the community will be represented in the trials.

“There is a concern that all aspects of the community won’t be represented as well as we would like because one of the ways that people get into clinical trials is through word of mouth and through trust,” he said. “For communities that have not historically been heavily a part of interventional clinical trials, the work to gain trust is that much more.” 

Shoham understands the leap of faith the researchers were asking of participants of the clinical trial. He mentioned that clinical trial demographics typically tend to skew toward people in the health-care field because they have a sensitivity to clinical trials and understand how they work and the importance of the data collected. There’s inherently a higher level of trust in the medical system, which allows them to submit to being treated by an experimental method. 

“We’re trying to explain in people’s best spoken language — whether it’s English or Spanish or another language — what we’re doing, the goal of what we’re doing, what the risks are, what the potential benefits are and then put them in the position to make the best decision for their body,” Shoham said. “All with the goal of letting people know that this study is out there, so that they can decide if it’s right for them to participate.”

According to Shoham, conversations with potential participants should not be approached as a way to convince them to sign up for a trial. Instead it should be considered as a way to provide them with accurate, easily understood information that will enable that to make the right decision for themselves and their families. 

“Even if there is no direct benefit to the person that’s participating, the information that we’re gaining is very important for us as a country and a world to understand how to prevent and treat coronavirus,” he said. 

If you are interested in participating in the clinical trials, call 888-506-1199 or visit www.covidplasmatrial.org

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