COVID-19 Sero-prevalence Health Care Workers Kinshasa (PRESTACOV)

• ClinicalTrials.gov Identifier: NCT04699058
• Recruitment Status: Completed
• First Posted: January 7, 2021
• Last Update Posted: December 2, 2022
• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborator: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
• Information provided by (Responsible Party): Veerle Vanlerberghe, Institute of Tropical Medicine, Belgium

Study Description

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.

Condition or disease	Intervention/treatment
SARS-CoV Infection; Seroprevalence	Diagnostic Test: COVID-antibody test

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1200 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: Sero-prevalence and Sero-conversion Study of Health Care Workers and Their Households, Democratic Republic of the Congo
• Actual Study Start Date: July 17, 2020
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 31, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Health care workers; questionnaire and COVID antibody test	Diagnostic Test: COVID-antibody test; Questionnaire and COVID-antibody test for all participants
Household members; questionnaire and COVID antibody test	Diagnostic Test: COVID-antibody test; Questionnaire and COVID-antibody test for all participants

Outcome Measures

Primary Outcome Measures :

1. COVID antibody prevalence in Health care workers (serological test) [ Time Frame: Month 2 ]
   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
2. COVID antibody prevalence in Household members (serological test) [ Time Frame: Month 2 ]
   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
3. Seroconversion COVID Health care workers (serological test) [ Time Frame: Month 6 ]
   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
4. Seroconversion COVID household members (serological test) [ Time Frame: Month 6 ]
   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

Secondary Outcome Measures :

1. work-related exposure evaluated through a questionnaire and summarized as a score [ Time Frame: Month 6 ]
   the higher the score, the more exposed to the work-related risk factors (infrastructural, availability of equipment and behavioral); the higher the association is of a seroconversion with a higher score, the higher is the work-related exposure a risk factor for seroconversion.
2. behavioural risk factors (questionnaire), summarized as a score [ Time Frame: Month 6 ]
   the higher the score, the more exposed to risk behaviours (mobility, household); the higher the association is of a seroconversion with a higher score, the higher is the behaviour-related exposure a risk factor for seroconversion.

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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

Exclusion criteria: not giving consent

Contacts and Locations

Locations

Congo, The Democratic Republic of the

Institut Nationale de recherche Biomédicale

Kinshasa, Congo, The Democratic Republic of the

Sponsors and Collaborators

Institute of Tropical Medicine, Belgium

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

Investigators

• Principal Investigator: Veerle Vanlerberghe, PhD; ITG

More Information

• Responsible Party: Veerle Vanlerberghe, Principal Investigator, Institute of Tropical Medicine, Belgium
• ClinicalTrials.gov Identifier: NCT04699058
• Other Study ID Numbers: B3002020000144
• First Posted: January 7, 2021
• Last Update Posted: December 2, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: COVID-19 related information (sero-prevalence, individual status of infection, etc.) will not be made available openly to avoid stigmatisation, they will be made available upon request using a data sharing agreement to assure confidentiality for the individuals.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Antibodies; Immunologic Factors; Physiological Effects of Drugs