NCT04354792

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

April 16, 2020

Last Update Submit

June 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Differentiation between low risk and high risk HCWs

    2 months through out duration of study

Interventions

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

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Age: From 25 to 60 years old
  • Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.

You may not qualify if:

  • pregnant
  • Age over 60 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospital

Cairo, 11559, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 32105632BACKGROUND
  • 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.

    PMID: 32183930BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum SARsCOV-2 IGg to assess immunological state of HCWs

Study Officials

  • Ahmed M Mukhtar, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of anesthesia and intensive care

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 21, 2020

Study Start

May 1, 2020

Primary Completion

June 10, 2020

Study Completion

June 10, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations