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The purpose of this study is to identify healthcare workers with SARS CoV 2 antibodies who have not been previously diagnosed and are presumed COVID-19 negative, then determine the level of immunity in this population which could inform further decisions about widespread antibody testing in a healthcare worker population.
Enrolled participants will complete a survey gauging their level of confidence they will be antibody positive. Participants will then complete serologic testing for SARS CoV 2 IgG antibodies. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between a pre-test confidence level using a Likert scale and actual antibody positivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serologic Arm | Other | Enrolled participants will have COVID19 IgG antibody testing performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serologic testing | Other | COVID19 IgG antibody testing to be performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With COVID-19 Antibodies | Presence of IgG antibodies detected | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Predict Immune Status/Antibody Positivity | Survey of participants to gauge their confidence they will be antibody positive | Single point in time prior to COVID-19 Antibody testing |
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Inclusion Criteria:
Exclusion Criteria:
- Refusal to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Parkulo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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394 invited to participate. 300 elected to participate. 292 completed study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Serologic Arm | Enrolled participants will have COVID19 IgG antibody testing performed. Serologic testing: COVID19 IgG antibody testing performed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Serology Group | Group of participants completing COVID Serologic antibody testing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With COVID-19 Antibodies | Presence of IgG antibodies detected | Posted | Count of Participants | Participants | 1 month |
|
|
Participants were instructed to contact investigators if they developed any adverse events within 1 week of blood draw.
Bleeding, pain, infection, neurologic symptoms
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serologic Arm | Enrolled participants will have COVID19 IgG antibody testing performed. Serologic testing: COVID19 IgG antibody testing to be performed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Parkulo, MD | Mayo Clinic | 9049532000 | parkulo.mark@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2020 | Feb 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Ability to Predict Immune Status/Antibody Positivity | Survey of participants to gauge their confidence they will be antibody positive | Of 292 participants completing the study, 27 responded in a survey (prior to antibody testing) that they had a high confidence (8 or greater on a Likert Scale from 0-10) that they had been previously infected with SARS CoV-2 and would test COVID-19 antibody positive. Antibody results from those 27 participants are listed below. | Posted | Count of Participants | Participants | Single point in time prior to COVID-19 Antibody testing |
|
|
|
| 0 |
| 292 |
| 0 |
| 292 |
| 0 |
| 292 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |