Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV2 Infection

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• South Africa
  • GP
    • Johannesburg, GP, South Africa, 2192
      • Chris Hani Baragwanath Academic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Any HCWs of any staff category at the study hospitals

Description

Inclusion Criteria:

• HCWs of any staff category at the study hospitals.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To define the duration of viral "shedding".	To define the duration of "shedding" (using molecular based PCR methods) of SARS-CoV-2 in HCW who are identified to be infected with the virus.	2020
To do sero-epidemiology assessment.	To undertake serial sero-epidemiology studies on prevalence of SARS-CoV-2 antibodies among HCW.	2022
To analyse immune responses to SARS-CoV-2 infection.	To analyse immune responses (humoral and cell mediated) to SARS-CoV-2 infection.	2022
To investigate the possibility of viral re-infection in this population during the study period.	To investigate the possibility of viral re-infection during the different pandemic waves 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	To establish if common cold coronaviruses (CCCV) immunity confers protection against SARS-CoV-2 infection or disease severity by measuring antibodies to CCCV.	2022
To evaluate COVID-19 vaccine effectiveness (VE) amongst HCWs, against any PCR-confirmed SARS-CoV-2 infection.	To evaluate COVID-19 vaccine effectiveness (VE) amongst HCWs, against any PCR-confirmed SARS-CoV-2 infection.	2022
To measure humoral and cell mediated immune responses to COVID-19 vaccines stratified by previous SARS-CoV-2 infection.	To measure humoral and cell mediated immune responses to COVID-19 vaccines stratified by previous SARS-CoV-2 infection.	2022

Collaborators and Investigators

• Sponsor: Farzanah Laher

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: 200405

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No