NCT04469647

Brief Summary

Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and undetectably. Serology is an antibody test that provides additional information to polymerase chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the population that was infected . Seroconversion is the development of antibodies in the blood which can confirm suspected cases after the fact and reveal who was infected but asymptomatic and never realized it. Antibodies are specific proteins created as the body's response to the infection and this test is essential for detecting infected individuals with few or no symptoms at all.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 19, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 13, 2020

Last Update Submit

July 28, 2020

Conditions

COVID 19

Keywords

COVID 19CoronavirusSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Seroconversion status

    Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.

    6 Months

Secondary Outcomes (3)

  • The proportion of asymptomatic infections among staff who have seroconverted

    6 Months

  • The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH

    6 Months

  • Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers

    6 Months

Study Arms (2)

High-risk

Employees at high-risk of Coronavirus exposure areas (physicians, nurses, respiratory therapists, radiology technologists, lab technologists, housekeepers)

Diagnostic Test: Serology Test

Low-risk

Employees working at lower risk areas such as (administration, HR, Public relations)

Diagnostic Test: Serology Test

Interventions

Serology TestDIAGNOSTIC_TEST

Participants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2). at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test.

High-riskLow-risk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthcare workers, divided into two groups (High-risk and Low-risk).

You may qualify if:

  • Adult.
  • JHAH employee
  • Housekeepers (this group of staff are outsourced at JHAH)

You may not qualify if:

  • \. Any participant exhibiting COVID 19 symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Aramco Healthcare

Dhahran, Eastern Province, 31311, Saudi Arabia

Location

Related Publications (2)

  • Mushcab H, Al-Tawfiq JA, Babgi A, Ghamdi M, Amir A, Sheikh SS, Darwisheh A, AlObaid A, Masuadi E, AlFattani A, Qahtani S, Al Sagheir A. Longevity of Immunoglobulin-G Antibody Response Against Nucleocapsid Protein Against SARS-CoV-2 Among Healthcare Workers. Infect Drug Resist. 2023 May 31;16:3407-3416. doi: 10.2147/IDR.S400365. eCollection 2023.

    PMID: 37283943DERIVED

  • Mushcab H, Al-Tawfiq JA, Ghamdi M, Babgi A, Amir A, Sheikh SS, Darwisheh A, Alobaid A, Jebakumar AZ, Qahtani S, Al Sagheir A. A Cohort Study of Seroprevalence of Antibodies Against SARS-CoV-2 Infection Among Healthcare Workers at a Tertiary Hospital in Saudi Arabia. Infect Drug Resist. 2022 Aug 10;15:4393-4406. doi: 10.2147/IDR.S369755. eCollection 2022.

    PMID: 35974896DERIVED

Related Links

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 14, 2020

Study Start

July 19, 2020

Primary Completion

January 15, 2021

Study Completion

June 15, 2021

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

SA(1)