COVID-19 Sero-prevalence Health Care Workers Kinshasa

NCT04699058 | Completed

• 1 other identifier: B3002020000144
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cohort study, in which the investigators will follow-up 650 health care workers (HCW) and a selection of their households (of COVID positive and COVID negative HCW) at baseline and in three follow-up surveys, with 4 to 6 weeks of time interval. The investigators will select HCW from different wards and different health care structures in 5 communes of Kinshasa. Additionally, in the first survey among HCW, the investigators will test with different diagnostic platform to evaluate the performance of serological tests in the African setting and the effect of malaria infection on the performance of tests. An amendment is added to the protocol, stating an additional 2 surveys in april/June 2021 and October/November 2021 to evaluate impact of second wave and of vaccination campaign.

Conditions

SARS-CoV Infection; Seroprevalence

Outcome Measures

Primary Outcomes (4)

• COVID antibody prevalence in Health care workers (serological test)

  Antibody detection through ELISA and Luminex multiplex platform to estimate seroprevalence of SARS-CoV-2 infection among active HCW of hospitals and primary health care units of Kinshasa

  Month 2

• COVID antibody prevalence in Household members (serological test)

  Antibody detection through Luminex multiplex platform to estimate of SARS-CoV-2 infection among household members of active HCW of hospitals and primary health care units of Kinshasa

  Month 2

• Seroconversion COVID Health care workers (serological test)

  Serial antibody detection through Luminex multiplex platform to estimate incidence of SARS-CoV-2 seroconversions among HCW of hospitals and primary health care units of Kinshasa over a 5 months' time period

  Month 6

• Seroconversion COVID household members (serological test)

  Serial antibody detection through Luminex multiplex platform to estimate incidence of SARS-CoV-2 seroconversion among household members of active HCW of hospitals and primary health care units of Kinshasa over a five months' time period

  Month 6

Secondary Outcomes (2)

• work-related exposure evaluated through a questionnaire and summarized as a score

  Month 6

• behavioural risk factors (questionnaire), summarized as a score

  Month 6

Study Arms (2)

Health care workers

questionnaire and COVID antibody test

Diagnostic Test: COVID-antibody test

Household members

questionnaire and COVID antibody test

Diagnostic Test: COVID-antibody test

Interventions

COVID-antibody test DIAGNOSTIC_TEST

Questionnaire and COVID-antibody test for all participants

Health care workers; Household members

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Health care workers: All staff working in health care facilities of the selected health zones of Kinshasa: Lingwala, Bandalungwa, Limete, Ndjili and Lemba. Household members: All household members of participating Health care workers. Household members can be defined as the members of a household, which consists of a person or group of persons who live together in the same house, share the same housekeeping arrangements and usually eat meals together.

You may qualify if:

• For Both groups:
• Willing to provide written informed consent
• Health care workers
• Health care worker (all categories from specialist doctors to allied and auxiliary health workers) of the selected health services
• foreseen to be employed (or place of internship) for the next three months in he selected health facility
• Household members
• Willing not to change the residence during the study period
• Household member of included Health care workers

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator

Study Sites (1)

Institut Nationale de recherche Biomédicale

Kinshasa, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

\- For health care workers: Blood sample : a fingerprick , and one clotted blood tube to obtain serum (of 5 ml) \- For Household members: Dried Blood spots: a fingerprick to collect minimum 3 - max 6 whole bloodspots

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Veerle Vanlerberghe, PhD

  ITG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 7, 2021
• Study Start: July 17, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)