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About the study

Since COVID-19 first appeared in Wuhan, China in December 2019,  the virus that causes the infection (known as SARS-CoV-2) has rapidly spread to more than 185 countries including the United States. This has posed a serious global threat to the public health and economy. Healthcare workers have had high rates of exposure and infection compared to the general population and employees throughout Mass General Brigham (MGB), regardless of the extent of patient contact, may develop COVID-19 infection. Employees of MGB are considered essential workers and, depending on their role, may be largely unable to practice strict “social distancing” from patients and colleagues.

Serologic tests measure the level of antibodies in an individual. Antibodies to the virus that causes COVID-19 may be produced over several days to weeks after infection. The presence of antibodies indicates that a person was exposed to the COVID-19 virus, irrespective of whether the individual developed severe or mild disease or did not even experience symptoms of infection.

Testing blood samples for COVID-19 antibodies from the large population of MGB employees will be an important source of information from which to study COVID-19 antibodies in subjects who do not have symptoms as well as those who may develop COVID-19 symptoms during the course of the study. Detection of individuals’ immune response (ability to fight off disease symptoms) and the persistence of this response is of critical importance, particularly in the healthcare setting. This study offers a systematic approach to test consenting employees throughout our MGB organization.

Although the World Health Organization recently acknowledged the lack of evidence that the presence of antibodies to SARS-CoV-2 confers immunity in humans, our results will add to the body of knowledge about antibodies in hospital-based employees who do not have symptoms of COVID-19 and potentially identify persons who could continue to work or return to work without becoming re-infected or infecting others.

What is the Main Goal of this Study?
This is a 12-month research study to evaluate the baseline and emerging presence of SARS-CoV-2 antibodies in MGB employees who are currently not having symptoms of infection.  Because we are not testing employees who are currently having symptoms, this study does not involve testing for active COVID-19 infection (e.g., by PCR swab test).

What are Other Goals of the Study?

• To establish a resource to collect data from MGB employees on antibody results, information about the participants’ health status, and blood samples collected in an ongoing fashion over the course of one year. The resource will be managed by the MGB Biobank, and will support objectives of this and other Institutional Review Board (IRB)-approved research studies initiated by investigators throughout the MGB organization.
• To determine when and for how long antibodies against the virus that causes COVID-19 appear over a 12-month period.
• To determine the proportion of individuals who experience any of the following outcomes during the study period: clinically documented COVID-19 infection, hospitalization for COVID-19 related illness, Intensive Care Unit (ICU) stay for COVID-19 related illness, respiratory failure requiring mechanical ventilation related to COVID-19, and death due to COVID-19.
• To compare how often COVID-19 infection and anti-SARS-CoV-2 antibodies occur in: (1) Healthcare workers (HCW) with direct contact with known COVID-19 positive patients, (2) HCW with direct patient contact, but without contact with known COVID-19 positive patients, (3) Employees working in patient care areas without direct patient contact, and (4) Employees working in non-patient care areas.
• To determine if and how often COVID-19 infection reoccurs in antibody-positive subjects.
• DNA samples will be evaluated to identify any changes in an individual’s genes that indicates: (a) susceptibility to COVID-19 infection, (b) degree of symptom severity, (c) and degree and persistence of their ability to fight off infection.

Up to 500 individuals will be enrolled in an initial pilot portion of this study so that we may assess the challenges of doing a large-scale study across the entire MGB organization. We will use information gathered during this portion of the study to make sure that our procedures for having individuals join the study, data and sample collection, sample testing, and return of results to study participants are functioning properly.