COVID-19NCT05175963
Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection
An observational study of COVID-19 and SARS-CoV2 Infection, run by Farzanah Laher at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV2 Infection
- How many people
- 512 participants
- Where
- 1 siteSouth Africa
- Study dates
- 22 Apr 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any HCWs of any staff category at the study hospitals
Who may be able to join
- HCWs of any staff category at the study hospitals.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Chris Hani Baragwanath Academic Hospital
Johannesburg, GP, 2192
About this study
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.
- Conditions
- COVID-19, SARS-CoV2 Infection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2020
Secondary outcomes (7)
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.
Measured: 2020
To do sero-epidemiology assessment.
To undertake serial sero-epidemiology studies on prevalence of SARS-CoV-2 antibodies among HCW.
Measured: 2022
To analyse immune responses to SARS-CoV-2 infection.
To analyse immune responses (humoral and cell mediated) to SARS-CoV-2 infection.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start22 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farzanah Laher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Farzanah Laher, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175963
- Sponsor's protocol ID
- 200405
- Status last verified
- May 2024
- First submitted
- 2 Jan 2022
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection
- ClinicalTrials.gov ID
- NCT05175963
- Acronym / sponsor ID
- 200405
- Conditions
- COVID-19, SARS-CoV2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Farzanah LaherUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any HCWs of any staff category at the study hospitals
Key inclusion criteria (1 listed)
- HCWs of any staff category at the study hospitals.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the prevalence of symptomatic and asymptomatic SARS-CoV-2 infections among HCW.
Time frame: 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.
7 secondary outcomes
To define the duration of viral "shedding".
Time frame: 2020
To do sero-epidemiology assessment.
Time frame: 2022
To analyse immune responses to SARS-CoV-2 infection.
Time frame: 2022
To investigate the possibility of viral re-infection in this population during the study period.
Time frame: 2022
To establish if common cold coronaviruses (CCCV) immunity confers protection against SARS-CoV-2 infection or disease severity
Time frame: 2022
To evaluate COVID-19 vaccine effectiveness (VE) amongst HCWs, against any PCR-confirmed SARS-CoV-2 infection.
Time frame: 2022
To measure humoral and cell mediated immune responses to COVID-19 vaccines stratified by previous SARS-CoV-2 infection.
Time frame: 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV2 Infection, run by Farzanah Laher at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of symptomatic and asymptomatic SARS-CoV-2 infections among HCW. (time frame: 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.