Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

Not Applicable

Completed

• Conditions: SARS-CoV 2; COVID-19
• Interventions: Other: Serologic testing

• Registration Number: NCT04383587
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-12
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-31
• Results First Submitted: 2022-02-23
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Results First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serologic Arm	Serologic testing	Enrolled participants will have COVID19 IgG antibody testing performed.

Primary Outcome Measures

Name	Time	Method
Number of Participants With COVID-19 Antibodies	1 month	Presence of IgG antibodies detected

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States