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Asymptomatic COVID-19 Infection Among Healthcare Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354792
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mukhtar, Kasr El Aini Hospital

Study Description
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Brief Summary:
To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals

Condition or disease Intervention/treatment
Immunologic Activity Alteration 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 Design
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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : June 10, 2020
Actual Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
serum SARsCOV-2 IGg to assess immunological state of HCWs

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354792


Locations
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Egypt
Cairo University Hospital
Cairo, Egypt, 11559
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Ahmed M Mukhtar, M.D Cairo University
More Information
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Publications:

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Responsible Party: Ahmed Mukhtar, professor of anesthesia and intensive care, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04354792    
Other Study ID Numbers: N-31-2020
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections