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NCT04424017 Clinical Trial

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

COVID Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04424017
Other study ID # COVID-19\004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 7, 2020
Est. completion date October 30, 2020

Study information
Verified date March 2021
Source Egyptian Center for Research and Regenerative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1546
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Egypt ECRRM Cairo
Egypt Faculty of Medicine, Cairo University Cairo

Sponsors (4)
Lead Sponsor Collaborator
Egyptian Center for Research and Regenerative Medicine Academy of Scientific Research and Technology, Egypt, Cairo University, National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Describe the serological status of individuals in the study by presence of specific anti-SARS-CoV-2 antibodies 3 Months
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