CClinicalTrials.gg
CompletedNCT04354792Updated Jun 17, 2020

Asymptomatic COVID-19 Infection Among Healthcare Workers

An observational study in Immunologic Activity Alteration, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-17.

Sponsored by Kasr El Aini Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Ages
25 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Immunologic Activity Alteration

Browse trials for

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 500 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • pregnant
  • Age over 60 years
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testSerum 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

06

What researchers measure

Primary outcomes

  1. Number of IGg seropositive health care workers

    health care workers who have positive IGg in seum

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

Secondary outcomes

  1. Differentiation between low risk and high risk HCWs

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

    Time frame: 2 months through out duration of study

07

Study locations

1 site
  • Cairo University Hospital
    Cairo, 11559, Egypt
08

References and documents

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. doi: 10.1016/S2213-2600(20)30103-X. PubMed 32105632 ↗
  • 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). doi: 10.2807/1560-7917.ES.2020.25.22.20200604c. PubMed 32183930 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04354792
Lead sponsor
Kasr El Aini Hospital
Responsible party
Ahmed Mukhtar (professor of anesthesia and intensive care, Kasr El Aini Hospital) — Principal investigator
First posted
Apr 21, 2020
Start date
May 1, 2020
Primary completion
Jun 10, 2020
Completion
Jun 10, 2020
Last update
Jun 17, 2020

Study contacts

Ahmed M Mukhtar, M.D
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion