Asymptomatic COVID-19 Infection Among Healthcare Workers

Immunologic Activity Alteration Clinical Trial

Official title:

Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354792
• Other study ID #: N-31-2020
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: June 10, 2020

Study information

• Verified date: June 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 10, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunologic Activity Alteration
• Infection

Intervention

Diagnostic Test:
• Serum SARs COV 2 IGg screening in health care workers
Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization

Locations

Country	Name	City	State
Egypt	Cairo University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10). doi: 10.2807/1560-7917.ES.2020.25.10.2000180. — View Citation

Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of IGg seropositive health care workers	health care workers who have positive IGg in seum	single measurement from each person collected over 2 months
Secondary	Differentiation between low risk and high risk HCWs	to know positive IGg persons and IGg negative persons to understand risk factors	2 months through out duration of study