Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
Study NCT ID:
NCT04354792
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2020-04-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asymptomatic COVID-19 Infection Among Healthcare Workers
Sponsor:
Kasr El Aini Hospital
Organization:
Study Overview
Official Title:
Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: