Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection

• Sponsor: Shabir Madhi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05175963
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 24.2
• Patients Per Site Per Month: 41.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; SARS-CoV2 Infection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Surveillance Among Healthcare Workers for SARS-Coronavirus-2 Infection
• Actual Study Start Date: Apr 22, 2020
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. To do sero-epidemiology assessment. [2022]

   To undertake serial sero-epidemiology studies on prevalence of SARS-CoV-2 antibodies among HCW.

3. To analyse immune responses to SARS-CoV-2 infection. [2022]

   To analyse immune responses (humoral and cell mediated) to SARS-CoV-2 infection.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• HCWs of any staff category at the study hospitals.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chris Hani Baragwanath Academic Hospital	Johannesburg	GP	South Africa	2192

Sponsors and Collaborators

• Shabir Madhi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shabir Madhi, Professor, University of Witwatersrand, South Africa
• ClinicalTrials.gov Identifier: NCT05175963
• Other Study ID Numbers: 200405
• First Posted: Jan 4, 2022
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19

Study Results

No Results Posted as of Jan 4, 2022