Monday, April 13, 2020
New study aims to determine the total population with COVID-19 antibodies across a health system, identify potential convalescent plasma donors, better understand disease transmission and contribute to a scientifically-based methodology for returning people to work
Beaumont Health’s Research Institute is launching America’s largest serological testing study to help answer many questions surrounding the spread of COVID-19 and potentially help treat patients battling the virus.
Serological blood testing detects antibodies the body creates to fight an infection. In the case of COVID-19, antibodies might develop as soon as 3 to 6 days after infection. Even after the recovery from COVID-19, antibodies remain. In many other infections, antibodies offer immunity against reinfection. The study will begin to answer whether COVID-19 antibodies offer any protection post infection.
According to the Centers for Disease Control and Prevention, as many as 25 to 50% of people with COVID-19 might not show symptoms. However, those individuals could still spread the disease to others. Beaumont’s serological testing study will start solving this mystery by identifying the number of people across its 38,000 employees and thousands of affiliates who have COVID-19 antibodies who never reported any symptoms. Participation is voluntary.
Questions to be answered by the Beaumont study include:
- How susceptible are health care workers to acquiring COVID-19?
- What is the relationship between antibody levels to symptoms or the severity of the disease?
- Does our antibody response increase or decrease over time and how long will it last?
- Will COVID-19 antibodies protect you from a new COVID-19 infection?
The Beaumont Research Institute will focus the initial study solely on the Beaumont community of inpatients and the employees and affiliates of the health system.
“In addition to answering key questions on infection spread and the percentage of total asymptomatic cases in a community, we intend to relieve anxiety through a better understanding of the spread of the infection across Beaumont Health,” Beaumont Health Vice President for Research and Director of the Beaumont Research Institute Richard Kennedy, Ph.D, said.
Long term, the study aims to:
- Determine how serological testing can supplement swab-based molecular testing which looks for evidence of active infection
- Identify individuals with high antibody levels as potential donors for plasma transfusions to treat others infected with COVID-19
- Prioritize people for future vaccinations
- Help people get back to work by establishing testing protocols and a better understanding of COVID-19 immunity
To detect and analyze COVID-19 antibody levels, Beaumont Health will use two PerkinElmer, Inc. (NYSE: PKI), EUROLabWorkstations and EUROIMMUN Anti-SARS-CoV-2 ELISA testing kits which recently received CE marking in Europe. The Food and Drug Administration has authorized hospital labs to self-validate their own COVID-19 serological tests. This has already been completed under the direction of Beaumont Health immunologist Dr. Gabriel Maine.
After initial results are obtained from Beaumont patients and staff, the testing capability will be made available to other area hospital systems as needed.
Beaumont will rely upon phlebotomists from across the region to help draw blood from study participants. At a minimum, participants will have their blood drawn twice over two or more weeks to help better understand the rate of new infections and to assess persistence of COVID-19 antibodies.
The study’s principal investigator will be Beaumont’s Director of Infectious Diseases Research Matthew Sims, M.D., Ph.D.
“I believe having antibodies against COVID-19 will protect people from getting infected again and so do many other physicians. In Germany, there is a plan to give people ‘immunity passports’ if they can show they have antibodies to help them get back to work. This study will help prove that antibodies protect those who have them. It is our hope that this study provides a template for others to conduct similar research that will collectively clarify many unknowns of COVID-19,” Dr. Sims said.
A 2015 serological study of the MERS coronavirus tested 10,000 people in Saudi Arabia. Researchers extrapolated that nearly 45,000 people in the country might have been exposed to the virus as compared to fewer than 2,500 cases of MERS that were verified around the world.
The FDA has approved convalescent plasma transfusion as a therapeutic treatment. This approach has been used for other viral outbreaks such as measles, polio, mumps and influenza. Individuals who have high levels of COVID-19 antibodies in their system may be asked to donate plasma for convalescent plasma transfusions to treat gravely ill patients.
“This treatment has been used in China with some success, helping COVID-19 patients on ventilators and near death improve enough to begin breathing again on their own,” said Dr. Sims.
Beaumont, which has 38,000 employees, intends to use data collected through this study as part of its own return to work process. This study may serve as a model for how other businesses get their employees back to work.
“The study could also potentially make a difference on a larger scale as well by helping prioritize who should be vaccinated first when a vaccine hopefully becomes available over the next year and a half,” Beaumont Hospital, Royal Oak, Chief Medical Officer Dr. Barbara Ducatman said. “Individuals who do not have the antibodies or who have a low level of the antibodies should receive the vaccination first, while those with potentially significant levels of protection could wait a bit longer.”
This group of donors have contributed more than $3 million in philanthropic contributions to help support the initial funding for the research project: Sidney and Madeline Forbes; Nathan and Catherine Forbes; Levy Dresner Foundation; Stephen and Bobbi Polk; Warren Rose and the Rose Family; Mickey, Steven, Margie and Edward Shapiro; and Gwen and S. Evan Weiner.
“We are so grateful to these generous, long-time donors who have stepped up to support this important research. We could not proceed with this project without their support,” Beaumont Health CEO John Fox said.
NOTE: This test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose infection or to determine infection status.