Sero-prevalence of Coronavirus Disease 2019 (COVID-19) in Healthcare Workers

NCT ID: NCT04424017

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1546 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-07

Study Completion Date

2020-10-30

Brief Summary

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The medical and paramedical staff of the front-line services are potentially exposed to SARS-CoV-2. Therefore, despite the application of standard protective measures, it is possible that a certain number of these personnel have already contracted SARS-CoV-2, including in its asymptomatic form. Serological testing in this context would be useful for deploying immune healthcare workers as to limit the risk of viral infection and transmission. Therefore, it is of utmost importance to prove that the serological response entails the production of neutralizing antibodies.

Detailed Description

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Conditions

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COVID Corona Virus Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthcare workers (HCWs)

Specific anti-SARS-CoV-2 antibodies

Intervention Type BIOLOGICAL

A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.

All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).

Healthy blood donors and healthy subjects in blood bank

Specific anti-SARS-CoV-2 antibodies

Intervention Type BIOLOGICAL

A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.

All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).

Convalescents

Specific anti-SARS-CoV-2 antibodies

Intervention Type BIOLOGICAL

A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.

All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).

Interventions

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Specific anti-SARS-CoV-2 antibodies

A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.

All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Not previously diagnosed with COVID-19 except for convalescents
* Not currently symptomatic with fever or respiratory symptoms (cough, dyspnea)

Exclusion Criteria

* Patients with fever or respiratory symptoms (cough, dyspnea)
* Refusal to give informed consent, or contraindication to venipuncture.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

National Research Centre, Egypt

OTHER

Sponsor Role collaborator

Academy of Scientific Research and Technology, Egypt

OTHER

Sponsor Role collaborator

Egyptian Center for Research and Regenerative Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ECRRM

Cairo, , Egypt

Site Status

Faculty of Medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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COVID-19\004

Identifier Type: -

Identifier Source: org_study_id

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