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CompletedNCT04424017Updated Mar 9, 2021

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

An observational study in COVID and Corona Virus Infection, sponsored by Egyptian Center for Research and Regenerative Medicine. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by Egyptian Center for Research and Regenerative Medicine · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,546
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • COVID
  • Corona Virus Infection
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In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 1,546 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

This is the only study on the registry with Egyptian Center for Research and Regenerative Medicine as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with fever or respiratory symptoms (cough, dyspnea)
  • Refusal to give informed consent, or contraindication to venipuncture.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,546 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthcare workers (HCWs)

    Biological: Specific anti-SARS-CoV-2 antibodies

  • Healthy blood donors and healthy subjects in blood bank

    Biological: Specific anti-SARS-CoV-2 antibodies

  • Convalescents

    Biological: Specific anti-SARS-CoV-2 antibodies

Interventions

  • BiologicalSpecific 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).

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What researchers measure

Primary outcomes

  1. Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies

    Time frame: 3 Months

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Study locations

2 sites
  • ECRRM
    Cairo, 32, Egypt
  • Faculty of Medicine, Cairo University
    Cairo, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04424017
Lead sponsor
Egyptian Center for Research and Regenerative Medicine
Collaborators
Cairo University, National Research Centre, Egypt, Academy of Scientific Research and Technology, Egypt
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
Jun 7, 2020
Primary completion
Oct 30, 2020
Completion
Oct 30, 2020
Last update
Mar 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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