Largest COVID-19 Antibodies Study Launches

A new clinical study launching in Michigan aims to determine the total population with COVID-19 antibodies and contribute to a scientifically-based methodology for returning people to work.

Serological blood testing detects antibodies the body creates to fight infection.

In the case of COVID-19 disease, antibodies might develop as soon as 3 to 6 days after a SARS-CoV-2 coronavirus infection.

Even after the recovery from COVID-19, antibodies remain. In many other infections, antibodies offer immunity against reinfection.

Announced by Beaumont Health's Research Institute on April 13, 2020, the largest serological testing study in the USA intends to help answer many treatment questions surrounding the spread of COVID-19 disease.

According to the Centers for Disease Control and Prevention, as many as 50 percent 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, but are not limited to:

• How susceptible are healthcare workers in 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 said it ‘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 PerkinElmer, Inc., EUROLabWorkstations and EUROIMMUN Anti-SARS-CoV-2 ELISA testing kits which recently received CE marking in Europe.

The FDA 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 the persistence of COVID-19 antibodies.

The study's principal investigator will be Beaumont's Director of Infectious Diseases Research Matthew Sims, MD, 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.

SARS-CoV-2 clinical study news published by Coronavirus Today.