NCT04424017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,546

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

June 8, 2020

Last Update Submit

March 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

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

    3 Months

Study Arms (3)

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

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).

ConvalescentsHealthcare workers (HCWs)Healthy blood donors and healthy subjects in blood bank

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ECRRM

Cairo, 32, Egypt

Location

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 9, 2020

Study Start

June 7, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations