NASHVILLE, TN– While we approach a positive horizon with the development of promising vaccines, there is a continued need to identify effective treatments for individuals with COVID-19. One nationwide research study, called the Pass It On trial, is sweeping the country in search of a treatment option for patients hospitalized with COVID-19.
“Pass It On which stands for the Passive Immunity Trial for Our Nation” said Dr. Donald Alcendor “implies that the ability to successfully fight COVID-19 through antibodies, can be passed from one person to another through convalescent plasma.” Convalescent plasma is the liquid part of the blood with proteins that helps to fight infections.
Researchers Dr. Todd Rice and Dr. Wesley Self with Vanderbilt University Medical Center are leading this study to see if convalescent plasma helps patients who are hospitalized with COVID-19 recover. Convalescent plasma is collected from individuals who previously contracted and recovered from COVID-19 and those antibodies may be effective at treating patients hospitalized with the virus.
The Pass It On trial was made possible through a donation from Dolly Parton, and subsequent funding through the National Institutes of Health, and is hoping to enroll 1,000 participants at over 20 locations across the country.
Dr. Alcendor with Meharry Medical College has been a critical collaborator with the Pass It On trial. Dr. Alcendor is a molecular virologist who worked on the development of antiviral therapy for the Zika virus in 2016 and was asked by Dr. James Hildreth, President of Meharry Medical College, to develop a compound that will detect the SAR-CoV-2 virus that causes COVID-19. Dr. Hildreth, who he first met at UC Davis/Johns Hopkins while working in adjacent labs, is his greatest professional mentor. “He [Dr. Hildreth] gave me a solid opportunity to succeed and he watched over my success,” said Alcendor. Dr. Alcendor has always been fascinated by the abilities of viruses and wanted to pursue a career that would allow him to research ways to understand and fight them. His expertise and partnership with the Pass It On trial has been critical to helping raise awareness about the study.
Racial and Ethnic Disparities in Clinical Trials
There is a focused effort to include patients from diverse backgrounds, but enrollment of racial and ethnic minority groups in clinical trials is historically low. “As researchers, our focus is on identifying ways to prevent and treat COVID-19, but we cannot do that without research participation. Participating in this trial is critical and will help researchers potentially identify a treatment for COVID-19,” Dr. Alcendor said.
Higher Risk of COVID-19 Cases, Hospitalizations and Deaths in Minority Communities
Racial minorities are at a higher risk of contracting the virus due to social and health inequalities such as a lack of access to protective personal equipment, and being more likely to use public transportation and work essential jobs that expose them to others for long periods of time. Mixed-status, multigenerational households are also more at risk for contracting and spreading COVID-19. “The Hispanic community is particularly underserved”, said Alcendor. These communities are often uninsured or underinsured, leaving them without access to health care if they do get sick.
As of February 2021, the Centers for Disease Control and Prevention (CDC) reported that on average the risk of becoming sick, being hospitalized, or dying from COVID-19 is higher across all racial and ethnic minority groups in comparison to white, non-Hispanic persons.
The report notes Native American communities are the most disproportionately impacted of all minority groups, with the risk of getting the virus doubled and hospitalizations nearly quadrupled. The risk of death in this demographic is two-and-a-half that of non-Hispanic white patients.
African Americans are nearly three times as likely to be hospitalized with the virus and twice as likely to die with Hispanic patients similarly affected, the CDC reports.
Treatment options must be evaluated on a wide range of people, especially those that have been disproportionately impacted by COVID-19, to understand if they are effective or not. Determining what works and what doesn’t as soon as possible is crucial to understanding the virus, its evolutions, and how we can fight against it. If the antibodies from the plasma are found to be effective at treating the virus, patients could see a decrease in the effects and duration of viral infection.
Accessibility and Inclusion
The Pass It On trial has a website available in four different languages – English, Spanish, Chinese, and Arabic – and has translated forms into almost 30 different languages. The research team underscores the importance of inclusion, diversity, and cultural sensitivity in this trial, and hope that patients from different racial and ethnic backgrounds will feel comfortable taking part in the study.
Privacy Safeguards and Risks of Treatment
Study participants can be assured there are safeguards in place for monitoring side effects to treatment as well as privacy protection, Dr. Alcendor said. While rare, there may be minor risks to participants associated with receiving convalescent plasma and can include fever, rash, hives and headache. But patients will be regularly monitored while they are hospitalized.
Personal information of patients will only be available to the research team and patient information is protected under a Certificate of Confidentiality, meaning that the study team will not release that information even if requested for legal reasons.
Eligibility: Get Informed and Get Involved
While only patients who are hospitalized with COVID-19 at participating locations can take part in this study, there are other ways to help. Because the Pass It On study is using convalescent plasma to treat hospitalized patients, there is a tremendous need for plasma donations from people who have recovered from COVID-19 and live in the Nashville, TN area. If you are interested in becoming a plasma donor, you can contact the Vanderbilt Coordinating Center at 615-343-8010 or visit the study website at https://passitonstudy.org/become-a-plasma-donor/