Asymptomatic COVID-19 Infection Among Healthcare Workers

Completed

• Conditions: Immunologic Activity Alteration

• Registration Number: NCT04354792
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals

Detailed Description

The proposed study is a cross sectional study that will be carried out among HCWs in three University hospitals namely Kasr Alaini , Ain Shams , and Zagazeg Hospitals, employing a quantitative survey.

II-Study population Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.

Inclusion criteria Age: From 25 to 60 years old Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.

The potential participants will be given an information sheet and time to review this information before informed consent is sought. After the potential participants have agreed to be enrolled in the study, an informed consent will be obtained by the Investigator.

III- Procedures and Data collection:

Serum Collection and Interview A- Detecting Serum IgG against SARS-CoV2

Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization.(5) The sensitivity and specificity reported by the manufacturer for IgM are 88.2% and 99.0% respectively, and for IgG are 97.8% and 97.9%.

B- Structured Interview questionnaire

A structured - interview questionnaire using closed ended question format will be used to obtain information on:

1. Socio-demographic characteristics of the interviewees asking about age, sex, residence, education, occupation, department, Job title, hospital name, medical experience in years, marital status, living with family, and having children or not.

2. History of medical conditions, and history of performing procedures with transmission risk (date, place, type, duration, and frequency),

3. The use of personal protection, i.e., wearing of N95 masks, gloves, and gown, and consistent handwashing.

4. In addition, information will be collected regarding any clinical signs or symptoms in the worker past 3 months, including fever, cough, shortness of breath, or radiographically confirmed pneumonia.

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Study Start: 2020-05-01
• Status Verified: 2020-06
• Primary Completion: 2020-06-10
• Study Completion: 2020-06-10
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age: From 25 to 60 years old
• Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.

Exclusion Criteria

• pregnant
• Age over 60 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of IGg seropositive health care workers	single measurement from each person collected over 2 months	health care workers who have positive IGg in seum

Secondary Outcome Measures

Name	Time	Method
Differentiation between low risk and high risk HCWs	2 months through out duration of study	to know positive IGg persons and IGg negative persons to understand risk factors

Trial Locations

Locations (1)

Cairo University Hospital; 🇪🇬 Cairo, Egypt