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

Sponsor

Egyptian Center for Research and Regenerative Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04424017

Collaborator

Cairo University (Other), National Research Centre, Egypt (Other), Academy of Scientific Research and Technology, Egypt (Other)

1,546

Enrollment

Locations

4.8

Actual Duration (Months)

773

Patients Per Site

162.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID Corona Virus Infection	Biological: Specific anti-SARS-CoV-2 antibodies

Study Design

Study Type:

Observational

Actual Enrollment :

1546 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 7, 2020

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Healthcare workers (HCWs)	Biological: 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).
Healthy blood donors and healthy subjects in blood bank	Biological: 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).
Convalescents	Biological: 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).

Arm

Intervention/Treatment

Healthcare workers (HCWs)

Biological: 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).

Healthy blood donors and healthy subjects in blood bank

Biological: Specific anti-SARS-CoV-2 antibodies

Convalescents

Biological: Specific anti-SARS-CoV-2 antibodies

Outcome Measures

Primary Outcome Measures

Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies [3 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ECRRM	Cairo		Egypt	32
2	Faculty of Medicine, Cairo University	Cairo		Egypt

Sponsors and Collaborators

Egyptian Center for Research and Regenerative Medicine
Cairo University
National Research Centre, Egypt
Academy of Scientific Research and Technology, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Egyptian Center for Research and Regenerative Medicine

ClinicalTrials.gov Identifier:

NCT04424017

Other Study ID Numbers:

COVID-19\004

First Posted:

Jun 9, 2020

Last Update Posted:

Mar 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronavirus Infections

COVID-19

Antibodies

Study Results

No Results Posted as of Mar 9, 2021