COVID-19, SARS-CoV 2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERSerologic testing
COVID19 IgG antibody testing to be performed
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years old. * Mayo Clinic employee in procedural and surgical area. * Suspected COVID-19 exposure. * Completed PCR test twice with negative results.
Exclusion criteria
\- Refusal to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With COVID-19 Antibodies | 1 month | Presence of IgG antibodies detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Predict Immune Status/Antibody Positivity | Single point in time prior to COVID-19 Antibody testing | Survey of participants to gauge their confidence they will be antibody positive |
Countries
United States
Participant flow
Recruitment details
394 invited to participate. 300 elected to participate. 292 completed study.
Participants by arm
| Arm | Count |
|---|---|
| Serology Group Group of participants completing COVID Serologic antibody testing | 292 |
| Total | 292 |
Baseline characteristics
| Characteristic | Serology Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 284 Participants | — |
| Age, Continuous | 43 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 292 participants | — |
| Sex: Female, Male Female | 174 Participants | — |
| Sex: Female, Male Male | 118 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 292 |
| other Total, other adverse events | 0 / 292 |
| serious Total, serious adverse events | 0 / 292 |
Outcome results
Primary
Number of Participants With COVID-19 Antibodies
Presence of IgG antibodies detected
Time frame: 1 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serologic Arm | Number of Participants With COVID-19 Antibodies | Positive Antibodies | 8 Participants |
| Serologic Arm | Number of Participants With COVID-19 Antibodies | Negative Antibodies | 284 Participants |
Comparison: Participants were grouped by age (18-35 vs. 36-50 vs. 51-65 vs. \>65), Sex at birth (Female vs. Male). and Occupational Role (Technician vs Anesthesiologist vs Advanced Practice Provider vs. Attendant Aide vs. CRNA vs. OR nurse vs Perfusionist vs Surgeon).p-value: >0.18Fisher Exact
Secondary
Ability to Predict Immune Status/Antibody Positivity
Survey of participants to gauge their confidence they will be antibody positive
Time frame: Single point in time prior to COVID-19 Antibody testing
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serologic Arm | Ability to Predict Immune Status/Antibody Positivity | Antibody positive | 1 Participants |
| Serologic Arm | Ability to Predict Immune Status/Antibody Positivity | Antibody negative | 26 Participants |