NCT05175963

Brief Summary

This study aims to investigate the epidemiology of SARS-CoV-2 infection among: i) HCW who triage patients with suspected SARS-CoV-2 infection and provide care to COVID-19 patients; and ii) laboratory personnel who test clinical samples for SARS-CoV-2 infection. After the second wave of the pandemic enrolment will be widen to any person working at the study hospitals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

January 2, 2022

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the prevalence of symptomatic and asymptomatic SARS-CoV-2 infections among HCW.

    To determine the prevalence of symptomatic and asymptomatic PCR-confirmed SARS-CoV-2 infections among HCW using a systematic sampling strategy, coupled with investigation when clinically indicated.

    2020

Secondary Outcomes (7)

  • To define the duration of viral "shedding".

    2020

  • To do sero-epidemiology assessment.

    2022

  • To analyse immune responses to SARS-CoV-2 infection.

    2022

  • To investigate the possibility of viral re-infection in this population during the study period.

    2022

  • To establish if common cold coronaviruses (CCCV) immunity confers protection against SARS-CoV-2 infection or disease severity

    2022

  • +2 more secondary outcomes

Study Arms (5)

High Risk

Nurses (auxiliary nurses, enrolled nurses and professional nurses), medical doctors (interns, medical officers, registrars and consultants) and auxiliary/para-medical staff involved in the care of patients admitted for respiratory illnesses at Chris Hani Baragwanath Academic Hospital (CHBAH). This will include staff that have been assigned to work in: Internal Medicine: Staff working in the Ambulatory and Emergency Department, staff in the "pneumonia-admission" ward (ward 24), and staff in the COVID-19 confirmed case wards. Paediatrics: Staff involved in-hospital care of patients admitted to the dedicated "pneumonia ward" and COVID-19 cases wards. Intensive Care Unit: All medical staff working in the intensive care unit.

Low Risk

Nursing and medical-doctor staff that are working in the neonatal high-care and intensive care unit; who are likely to be at lower risk from SARS-CoV-2 acquisition in the health-care facility compared to their peers listed in Group 1.

Intermediate Risk

A third group, with a likely intermediate risk for hospital-facility based SARS-CoV-2 infection, are: VIDA staff involved in sample collection related to COVID-19, and laboratory personnel that will be involved in sample collection at VIDA. Nurses and medical doctors from the Obstetrics \& Gynaecology.

Mixed Risk

In 2021 with an eminent 3rd wave spreading across the country an additional group will be included comprising of any person working at CHBAH even if not in direct contact with patients.

TND group

Any person working at CHBAH or Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) and Helen Joseph Hospital (HJH) even if not in direct contact with patients.

Eligibility Criteria

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

Any HCWs of any staff category at the study hospitals

You may qualify if:

  • HCWs of any staff category at the study hospitals.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chris Hani Baragwanath Academic Hospital

Johannesburg, GP, 2192, South Africa

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 2, 2022

First Posted

January 4, 2022

Study Start

April 22, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations