COVID-19 Sero-prevalence Health Care Workers Kinshasa

NCT ID: NCT04699058

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2021-12-31

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.

Detailed Description

Rationale:

There is no information on how intense transmission of COVID-19 happens in Kinshasa, partly due to a reduced laboratory capacity for polymerase chain reaction (PCR) confirmation of acute cases, and an aspecific presentation of clinical symptoms. The focus of this COVID-19 seroprevalence study on health care workers and their households, was based on the following rationale. Health care workers (HCW) are among the groups at higher risk as they are directly or indirectly exposed to COVID-19 patients. They also form a group of specific interest as they are in close contact to vulnerable patients at high risk for severe COVID-19. In addition, their illness or absence from work significantly affects the health system's ability to respond to the COVID-19 pandemic and retain its other essential functions. HCW are trained in infection prevention and control (IPC). However, it is likely that at least some of them will get infected either at their workplace(s) or elsewhere. In particular health facilities with limited access to personal protective equipment (PPE) and regular water and sanitation facilities, IPC could even potentially be hampered, resulting in an increased risk of infection transmission among HCW, from HCW to their patients as well as to their household members. Because of this crucial role played by HCW in the transmission chain, it is of utmost importance to assess the proportion of asymptomatic infections among them.

Aim of the study:

This study aims to investigate severe acute respiratory syndrome (SARS-CoV-2) seroprevalence and seroconversion among HCW in Democratic Republic of Congo (DRC) and their household members, including asymptomatic ones, in order to generate insights into the transmission dynamics as well as the clinical presentation of the disease.

Primary objectives

• Determine seroprevalence of SARS-CoV-2 infection among active HCW of hospitals and primary health care units of Kinshasa at T0;
• Determine seroprevalence of SARS-CoV-2 infection among household members of active HCW of hospitals and primary health care units of Kinshasa at T0;
• Determine incidence of SARS-CoV-2 seroconversions among HCW of hospitals and primary health care units of Kinshasa over a 3 months' time period;
• Determine SARS-CoV-2 seroconversion among household members of active HCW of hospitals and primary health care units of Kinshasa over a three months' time period.

Secondary objectives

• Identify work-related risk factors (infrastructural, availability of equipment and behavioral) for seroconversion of HCW;
• Identify socio-demographic and behavioral risk factors for seroconversion of household members;
• Determine the proportion of asymptomatic cases among seroconversions occurred during the study period among HCW as well as among their household members;
• Assess secondary attack rate among household members of symptomatic and asymptomatic HCW.
• To compare the performance of an in-house Luminex platform serologic diagnostic test, commercialized antibody ELISA test and an antibody rapid diagnostic test (RDT) against the gold standard serological test (neutralization) in tropical settings with intense cocirculation of malaria and other infectious diseases

Description: 650 HCW and 1000 household members will be surveyed at 4 time moments. At each moment, a questionnaire is filled exploring the professional and community risk exposure and the appearance of symptoms compatible with a COVID infection. At the same time, a serum sample is taken by the HCW and a 'dried blood spot' is done by the household members. These samples will be analyzed to verify if the participants were exposed to the SARS-CoV2 since the start of the epidemic. The use of a cohort will allow us to describe how the epidemic evolves over a 4 to 6 month period in Kinshasa, but will also make it possible to evaluate how the antibodies are waning or not waning over time.

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

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Health care workers

questionnaire and COVID antibody test

COVID-antibody test

Intervention Type: DIAGNOSTIC_TEST

Questionnaire and COVID-antibody test for all participants

Household members

questionnaire and COVID antibody test

COVID-antibody test

Intervention Type: DIAGNOSTIC_TEST

Questionnaire and COVID-antibody test for all participants

Interventions

COVID-antibody test

Questionnaire and COVID-antibody test for all participants

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

For Both groups:

• Willing to provide written informed consent
• Being sick or having had COVID-19 is not an exclusion criterion

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Veerle Vanlerberghe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veerle Vanlerberghe, PhD

Role: PRINCIPAL_INVESTIGATOR

ITG

Locations

Institut Nationale de recherche Biomédicale

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

Other Identifiers

B3002020000144

Identifier Type: -

Identifier Source: org_study_id