Beaumont Health Large-scale Automated Serologic Testing for COVID-19

NCT04349202 | Completed FDA Device

• 1 other identifier: 2020-134
• Study Type: observational
• Target: 20,614
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine how peoples' bodies respond to exposure to COVID-19. Employees of Beaumont Health in Michigan who are older than 18 years may be eligible to participate. Participants from other high-risk groups who are not Beaumont employees may also be recruited, as may family members of Beaumont employees who have tested positive for COVID-19. Participants will have blood drawn two or more times for serology testing. This serology test will determine if participants have detectable levels of the antibodies that our bodies develop to fight COVID-19 infection. Participants will fill out a questionnaire each time they provide a blood sample. The questionnaires include questions about participants' personal traits; their health; general questions about their risk to exposure; job and risk of exposure; symptoms, diagnosis, treatment of COVID-19 since last blood draw. Researchers will monitor participants' medical records in a confidential manner for one year after the last blood draw to help determine if people who develop antibodies to COVID-19 are protected against developing a COVID-19 infection in the future.There may be no direct benefits for participants; however, information from this study may benefit other people by increasing our understanding of COVID-19, how it spreads from person to person, and how people respond to fight off the infection.The results of the serology test are used for research only and will not affect clinical decisions regarding participants' treatment or quarantine

Conditions

COVID-19; Coronavirus Infection; Severe Acute Respiratory Syndrome Coronavirus 2

Keywords

Exposure, Occupational; COVID-19 virus infection; COVID-19 pandemic; COVID-19 virus testing; SARS-CoV-2 antibodies

Outcome Measures

Primary Outcomes (1)

• Prevalence COVID antibodies in employees of Beaumont Health

  Number of participants testing positive for the presence of IgG or IgA antibodies to SARS-CoV-2 using the EUROIMMUN Serology testing platform. Serology testing of Beaumont Health employees will allow an estimation of asymptomatic carriage and help determine level of nosocomial spread of COVID-19 within our institution among its employees. All participants will provide a minimum of 2 blood draws between 2 and 4 weeks apart to determine the presence of antibodies to COVID-19. Participants at medium risk for exposure in their job function at Beaumont will have 3 draws 2-4 weeks apart and people considered the highest risk, those who provide the direct patient care to COVID-19 patients, will be tested 2-4 weeks apart until the pandemic in Michigan is under control (estimated to be 8 blood draws).

  1 year

Secondary Outcomes (11)

• COVID-19 re-infection in participants positive for antibodies to SARS-CoV-2

  1 year

• Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgG antibodies

  1 yr

• Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgG antibodies

  1 yr

• Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgA antibodies

  1 yr

• Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgA antibodies

  1 yr

Study Arms (1)

Beaumont employees

Beaumont employees (employees and affiliated non-employed physicians and advanced practice providers) undergoing serology testing for SARS-CoV-2 antibodies, their immediate family members, and members of other high-risk groups.

Diagnostic Test: EUROIMMUN assay

Interventions

EUROIMMUN assay DIAGNOSTIC_TEST

Serology testing to detect SARS-CoV-2 antibodies

Beaumont employees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Beaumont Health Employees and affiliated non-employed physicians and advanced practice providers Immediate family members of Beaumont Health employees, affiliated non-employed physicians and advance practice providers who have tested positive for SARS-CoV-2 antibodies Members of other high-risk populations as determined by the investigators who are specifically invited by Dr. Sims, Dr. Kennedy or Dr. Maine

You may qualify if:

• Beaumont Health employees and affiliated non-employed physicians and advanced practice providers
• Immediate family members of Beaumont Health employees, affiliated non-employed physicians and advance practice providers who have tested positive for SARS-CoV-2 antibodies
• non-Beaumont employees who are specifically invited to participate in the study by Dr. Sims, Dr. Kennedy, or Dr. Maine
• All ages

You may not qualify if:

• Decisionally impaired
• Individuals symptomatic for COVID-19 \<72 hours prior to testing appointment

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (2)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

Related Publications (2)

• Sims MD, Podolsky RH, Childers KL, Higgins B, Trueman J, Homayouni R, Voss DR, Berkiw-Scenna N, Keil H, Kennedy RH, Maine GN. Dried blood spots are a valid alternative to venipuncture for COVID-19 antibody testing. J Immunol Methods. 2023 Feb;513:113420. doi: 10.1016/j.jim.2022.113420. Epub 2022 Dec 31.

  PMID: 36596443 DERIVED

• Sims MD, Maine GN, Childers KL, Podolsky RH, Voss DR, Berkiw-Scenna N, Oh J, Heinrich KE, Keil H, Kennedy RH, Homayouni R. Coronavirus Disease 2019 (COVID-19) Seropositivity and Asymptomatic Rates in Healthcare Workers Are Associated with Job Function and Masking. Clin Infect Dis. 2021 Jul 30;73(Suppl 2):S154-S162. doi: 10.1093/cid/ciaa1684.

  PMID: 33150375 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Matthew Sims, MD, PhD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: April 10, 2020
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)