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NCT04425889 Clinical Trial

COVID-19 Antibodies Among Healthcare Workers

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04425889
Other study ID # IF20-00008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 5, 2020
Est. completion date June 1, 2020

Study information
Verified date June 2020
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date June 1, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Mexico Hospital Universitario José E. Gonzalez Monterrey Nuevo Leon

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of antibody presence of IgG and/or IgM against SARS-CoV-2 through study completion, an average of 8 weeks
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