COVID-19 Antibodies Among Healthcare Workers

June 10, 2020 updated by: Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez

Prevalence of SARS-CoV-2 Antibodies Among Healthcare Workers in a COVID-19 Unit

Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance to contaminated areas were included. They were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used for antibody detection, and selected participants were subject to real time polymerase chain reaction (qPCR) for SARS-CoV-2.

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario José E. Gonzalez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthcare workes of any category that are 18 years of age or older, who work in the COVID-19 unit at the University Hospital and hve been diagnosing and treating suspected or confirmed cases of COVID-19

Description

Inclusion Criteria:

  • All healthcare workers who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance were included

Exclusion Criteria:

  • Healthcare workers who did not have exposure for more or equal 14 days
  • Healthcare workers who did not wish to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exposed Healthcare workers
Healthcare workers working for 8 weeks in a COVID-19 area
Diagnostic test: COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)
a blood sample is drained for detection of IgG and IgM antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of antibody
Time Frame: through study completion, an average of 8 weeks
presence of IgG and/or IgM against SARS-CoV-2
through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2020

Primary Completion (ACTUAL)

May 30, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IF20-00008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)

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