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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• Severe Acute Respiratory Syndrome

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