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

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.

Study Overview

• Status: Completed
• Conditions: COVID; Corona Virus Infection
• Intervention / Treatment: Biological: Specific anti-SARS-CoV-2 antibodies

• Study Type: Observational
• Enrollment (Actual): 1546

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 32
    • ECRRM
  • Cairo, Egypt
    • Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Age-stratified sample from general population with 3 subgroups:

1. Healthcare workers (HCWs), comprising frontline doctors, nurses, health attendants, and receptionists.
2. Healthy blood donors and healthy subjects in blood bank or laboratory (routine examinations as pre-employment, likely to be representative of the general population
3. Convalescents

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies	3 Months

Collaborators and Investigators

• Sponsor: Egyptian Center for Research and Regenerative Medicine
• Collaborators: Cairo University; National Research Centre, Egypt; Academy of Scientific Research and Technology, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: COVID-19\004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No