- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349202
Beaumont Health Large-scale Automated Serologic Testing for COVID-19 (BLAST COVID-19)
Study Overview
Status
Intervention / Treatment
Detailed Description
Beaumont Health is an eight-hospital regional health care system with a total of 3,337 beds, 38,000 employees and 5,000 physicians in Southeast Michigan. In the first 3 weeks of the COVID-19 pandemic within Michigan over 3300 patients tested positive through our system and over 1000 have been admitted for inpatient care. COVID-19 has a wide range of presentations from asymptomatic to multisystem organ failure and death. Spread from asymptomatic individuals has been described in the literature but the extent of this transmission is unclear. Large scale serologic testing can help address this question by detecting antibodies generated after an individual is infected with COVID-19. Healthcare workers have developed COVID-19 but the true infection rate among those who care for COVID-19 patients and whether the infection occurs at work is unknown.
Every day, thousands of Beaumont physicians, nurses, technicians and other caregivers are working under extraordinary stress, doing their very best to care for patients with this highly contagious and potentially deadly virus. They are trying to protect themselves from infection while dealing with personal protective equipment requirements and limited knowledge of who in the hospital environment may be carrying the infection and potentially spreading it among the staff. Caregivers are at greater risk of infection than the public, and when they become sick, it reduces the number of trained personnel available to care for hospitalized patients. Serological testing would give Beaumont's front-line staff, family members and patients peace of mind by determining infection rates in our care units. Knowing the infection rates will demonstrate how effective the use of personal protective equipment has been for staff, whether any flaws exist in the system, and how many clinical staff currently have potentially protective antibodies.
Beaumont Health has 2 EURO Lab Workstations capable of running the SARS-CoV-2 IgG and IgA EUROIMMUN serology assay (referred to as the EUROIMMUN assay hereafter). Each EUROIMMUN assay consists of 2 separate tests; one of which measures IgG (the memory antibody which should give long acting resistance to people who mount an immune response) and the second of which measures IgA (the secretory antibody that should protect against infection through mucous membranes). Researchers can run 5,000 samples a day with each sample being tested for IgA and IgG.
Potential participants (employees and affiliated non-employed physicians and advanced practice providers) will provide informed consent. Researchers will analyze all participants over 2 blood draws between 2 and 4 weeks apart to see if they developed 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). If the participants agree, researchers will bank 0.5 ml of serum for future testing related to COVID-19. An initial questionnaire and subsequent questionnaires with each blood draw will be completed by participants. Biostatistics will analyze the data from the questionnaires and the serology test to determine any links between level of risk associated with the participants job, medical history, and exposure history to development of COVID-19 antibodies. Participants medical records will be monitored for one year to see if they are diagnosed with COVID-19 and if they have a positive PCR test for COVID-19 since they were tested for the presence of antibodies. All employees identified as developing COVID-19 after their antibody levels were tested will be analyzed and a correlation between antibody level and development of COVID-19 will be generated. This will allow an estimation of the protective effect of antibodies relative to people who have no detectable antibodies. Researchers will perform an epidemiologic analysis to identify contacts between staff and patients based on records in the EMR and can cross reference to determine if nosocomial transmission is likely occurring from staff to patients and vice versa. Researchers will also determine if there was any likely exposure to patients with COVID-19 on the same floor or if prior patients in the room had COVID-19. This will also allow researchers to model the rate of spread of the virus within the hospital from unknown sources.
Additional studies on subpopulations of participants will test whether antibody tests on dried blood spots (small drops of blood applied to filter paper, which do not have to be refrigerated) correlate with results obtained from drawing a full vial of blood. Reproducibility, stability, the effect of shipping, inter-lab concordance and any differences between participant-collected and phlebotomist-collected blood spot samples will be tested.
An additional subpopulation study will test immediate family members of participants who test positive for SARS-CoV-2 antibodies to evaluate intra-family spread of the disease. Another subpopulation study will recruit participants from other high-risk populations at the discretion of the investigators.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Michigan
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Royal Oak, Michigan, United States, 48073
- Beaumont Health System
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Royal Oak, Michigan, United States, 48073
- Beaumont Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Decisionally impaired
- Individuals symptomatic for COVID-19 <72 hours prior to testing appointment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Serology testing to detect SARS-CoV-2 antibodies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence COVID antibodies in employees of Beaumont Health
Time Frame: 1 year
|
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).
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 re-infection in participants positive for antibodies to SARS-CoV-2
Time Frame: 1 year
|
Number of participants with positive detection of anti-SARS-CoV-2 antibodies using the EUROIMMUN Serology testing platform, who later develop a COVID-19 infection as documented in Beaumont Health electronic medical records
|
1 year
|
Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgG antibodies
Time Frame: 1 yr
|
Number of participants with positive SARS-CoV-2 serum IgG antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test positive for anti-SARS-CoV-2 IgG antibodies using dried blood spot samples
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1 yr
|
Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgG antibodies
Time Frame: 1 yr
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Number of participants with negative SARS-CoV-2 serum IgG antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test negative for anti-SARS-CoV-2 IgG antibodies using dried blood spot samples
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1 yr
|
Correlation of dried blood spot and standard blood sampling positive for COVID-19 IgA antibodies
Time Frame: 1 yr
|
Number of participants with positive SARS-CoV-2 serum IgA antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test positive for anti-SARS-CoV-2 IgA antibodies using dried blood spot samples
|
1 yr
|
Correlation of dried blood spot and standard blood sampling negative for COVID-19 IgA antibodies
Time Frame: 1 yr
|
Number of participants with negative SARS-CoV-2 serum IgA antibodies using the EUROIMMUN Serology testing platform from standard collection of 1 vial (approximately 5ml) of blood who also test negative for anti-SARS-CoV-2 IgA antibodies using dried blood spot samples
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1 yr
|
Reproducibility of SARS-CoV-2 IgG antibody detection from dried blood spots
Time Frame: 1 yr
|
Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from separate blood spot samples collected on the same day
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1 yr
|
Stability of dried blood spots for SARS-CoV-2 IgG antibody detection
Time Frame: 1 year
|
Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from blood spots collected on the same day but tested after 7 to 28 days of storage
|
1 year
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Effect of shipping on dried blood spot samples for SARS-CoV-2 IgG antibody detection
Time Frame: 1 yr
|
Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from dried blood spot samples processed at Beaumont Health and those shipped to EUROIMMUN (Lubeck, Germany) for testing
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1 yr
|
Accuracy of participant-performed blood spot collection for SARS-CoV-2 IgG antibody detection
Time Frame: 1 yr
|
Number of participants with identical SARS-CoV-2 IgG antibody results using the EUROIMMUN Serology testing platform from dried blood spot samples collected by a phlebotomist and those self-collected by the participant using an instructional information sheet
|
1 yr
|
Ease of participant-performed blood spot collection
Time Frame: 1 yr
|
Ease of following an instructional information sheet to self-collect blood spots will be rated by the participant on a 10 point scale where 1 indicates complete comfort and understanding the collection procedure and 10= extreme difficulty with understand the information sheet and collecting blood spots
|
1 yr
|
Correlation of SARS-CoV-2 antibodies between immediate family members
Time Frame: 1 yr
|
Number of immediate family member participants testing positive for SARS-CoV-2 IgG antibodies using the EUROIMMUN Serology testing platform following a SARS-CoV-2 IgG antibody positive assay in a Beaumont Health employee participant
|
1 yr
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew Sims, MD, PhD, William Beaumont Hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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