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NCT05175963 Clinical Trial

Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection

COVID-19 Clinical Trial

Official title:
Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05175963
Other study ID # 200405
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 22, 2020
Est. completion date April 30, 2022

Study information
Verified date May 2024
Source University of Witwatersrand, South Africa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 512
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - HCWs of any staff category at the study hospitals. Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
South Africa Chris Hani Baragwanath Academic Hospital Johannesburg GP

Sponsors (1)
Lead Sponsor Collaborator
Farzanah Laher

Country where clinical trial is conducted

South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary To do sero-epidemiology assessment. To undertake serial sero-epidemiology studies on prevalence of SARS-CoV-2 antibodies among HCW. 2022
Secondary To analyse immune responses to SARS-CoV-2 infection. To analyse immune responses (humoral and cell mediated) to SARS-CoV-2 infection. 2022
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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