Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

NCT04383587 | Completed Results

• 1 other identifier: 20-004054
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV 2; COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants With COVID-19 Antibodies

  Presence of IgG antibodies detected

  1 month

Secondary Outcomes (1)

• Ability to Predict Immune Status/Antibody Positivity

  Single point in time prior to COVID-19 Antibody testing

Study Arms (1)

Serologic Arm

OTHER

Enrolled participants will have COVID19 IgG antibody testing performed.

Other: Serologic testing

Interventions

Serologic testing OTHER

COVID19 IgG antibody testing to be performed

Serologic Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Mayo Clinic employee in procedural and surgical area.
• Suspected COVID-19 exposure.
• Completed PCR test twice with negative results.

You may not qualify if:

• \- Refusal to participate in this study.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mark A. Parkulo, MD
• Organization: Mayo Clinic

parkulo.mark@mayo.edu

9049532000

Study Officials

• Mark Parkulo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: May 6, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 31, 2020
• Last Updated: April 13, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)