Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection

Completed

• Conditions: COVID-19; SARS-CoV2 Infection

• Registration Number: NCT05175963
• Lead Sponsor: Farzanah Laher

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-22
• Study First Submitted: 2022-01-02
• Study First Submitted QC: 2022-01-02
• Study First Posted: 2022-01-04
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

Inclusion Criteria

• HCWs of any staff category at the study hospitals.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the prevalence of symptomatic and asymptomatic SARS-CoV-2 infections among HCW.	2020	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chris Hani Baragwanath Academic Hospital; 🇿🇦 Johannesburg, GP, South Africa