An interventional study of Serologic testing in SARS-CoV 2 and COVID-19, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enrolled participants will have COVID19 IgG antibody testing performed.
Other: Serologic testing
COVID19 IgG antibody testing to be performed
Number of Participants With COVID-19 Antibodies
Presence of IgG antibodies detected
Time frame: 1 month
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
394 invited to participate. 300 elected to participate. 292 completed study.
| Milestone | Serologic Arm |
|---|---|
| Started | 300 |
| Completed | 292 |
| Not completed | 8 |
Presence of IgG antibodies detected
| Participants | Serologic Arm |
|---|---|
| Positive Antibodies | 8 |
| Negative Antibodies | 284 |
Survey of participants to gauge their confidence they will be antibody positive
| Participants | High Confidence of Previous Infection |
|---|---|
| Antibody negative | 26 |
| Antibody positive | 1 |
Collected over Participants were instructed to contact investigators if they developed any adverse events within 1 week of blood draw.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Serologic Arm | 0/292 (0%) | 0/292 (0%) | 0/292 (0%) |
| Age, Categorical(Participants) | Serology Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 284 |
| >=65 years | 8 |
| Age, Continuous(years) | Serology Group |
|---|---|
| Mean | 43 (18 to 75) |
| Sex: Female, Male(Participants) | Serology Group |
|---|---|
| Female | 174 |
| Male | 118 |
| Race and Ethnicity Not Collected(Participants) | Serology Group |
|---|
| Region of Enrollment(participants) | Serology Group |
|---|---|
| United States | 292 |
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Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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