COVID-19 Clinical Trial
Official title:
Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection
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 |
Verified date | May 2024 |
Source | University of Witwatersrand, South Africa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
South Africa | Chris Hani Baragwanath Academic Hospital | Johannesburg | GP |
Lead Sponsor | Collaborator |
---|---|
Farzanah Laher |
South Africa,
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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