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OpenTrials
Completed

NCT Number: NCT04354792

Asymptomatic COVID-19 Infection Among Healthcare Workers

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

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University Hospital

Cairo, 11559, Egypt

About this study

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:

  • 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.
  • History of medical conditions, and history of performing procedures with transmission risk (date, place, type, duration, and frequency),
  • The use of personal protection, i.e., wearing of N95 masks, gloves, and gown, and consistent handwashing.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum SARs COV 2 IGg screening in health care workers

Diagnostic Test

Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization

Primary outcomes

  1. Number of IGg seropositive health care workers

    Time frame: single measurement from each person collected over 2 months

    health care workers who have positive IGg in seum

Secondary outcomes

  1. Differentiation between low risk and high risk HCWs

    Time frame: 2 months through out duration of study

    to know positive IGg persons and IGg negative persons to understand risk factors

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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