Asymptomatic COVID-19 Infection Among Healthcare Workers

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

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

Study Overview

• Status: Completed
• Conditions: Immunologic Activity Alteration
• Intervention / Treatment: Diagnostic test: Serum SARs COV 2 IGg screening in health care workers

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • Cairo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Ahmed M Mukhtar, M.D, Cairo University

Publications and helpful links

General Publications

• 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.
• 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):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180. Erratum In: Euro Surveill. 2020 Jun;25(22):

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): June 10, 2020
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: N-31-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No