Transmission Dynamics of COVID-19 in a Rural Setting of the Democratic Republic of the Congo

NCT04701996 | Completed

• 1 other identifier: B3002020000141
• Study Type: observational
• Target: 1,709
• Locations: 1 country
• Sites: 1

Brief Summary

A fixed cohort of adults in rural Kimpese will be followed up every two months since they are assumed to be at above average risk of contracting COVID-19. Every two months these individuals will be interviewed with a focus on COVID-19 related symptoms and possible exposure to the disease and have their temperature recorded. A social mixing survey will also be carried out to assess human contact behaviour. The data generated will help inform mathematical modelling that can predict which proportion of the population per age group is likely to get infected once COVID-19 is introduced in this rural population, and the epidemic size if no intervention, as well as when targeted interventions are introduced. During the outbreak, physical distancing measures could be implemented. The monitoring of social contacts, again using a social-mixing survey, will contribute to the understanding of the impact of such measures in a rural context on transmission of SARS-CoV-2. The results from the seroprevalence over time, will be used to refine and validate the predictions from the modelling results, (re)calibrate the model where needed, and test hypotheses on transmission-dynamics of COVID-19. In case of an established epidemic of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the Health Zone of Kimpese, the sero-surveillance will be extended from an assumed high risk cohort to a representative sample of the overall population. Moreover, support to the COVID-19 control measures will be provided by the study team. The national guidelines recommend household transmission investigation for the first 100 confirmed laboratory cases. During the household visit, information on symptoms and one serum sample will be requested of all household members of the index case. If household members are present with symptoms and fever, the COVID-19 outbreak team of Kimpese will provide diagnostic testing and medical care.

Conditions

Covid19

Keywords

serological test

Outcome Measures

Primary Outcomes (2)

• To predict and monitor the transmission of SARS-CoV-2 in a rural Sub Saharan setting.

  qualitative and quantitative monitoring of antibody response against SARS-CoV-2. Wantai SARS CoV-2 (Ig + IgM) is used for the detection of total Ig and IgM antibodies against SARS-CoV-2. This assay allows for qualitative (antibodies present or absent) and quantitative detection of antibodies. The amount of colour intensity is measured and is proportional to the amount of antibody captured inside the wells, and to the sample respectively (quantitative result)

  1 year

• To inform intervention strategies targeted at limiting the spread of COVID-19 in a rural Sub Saharan setting.

  To combine all information to inform dynamic transmission model that can simulate the spread of SARS-CoV-2 and the effect of intervention strategies to inform public health policy.

  1 year

Secondary Outcomes (1)

• To create social contact matrices that can be used to parameterise dynamic transmission models.

  1 year

Other Outcomes (1)

• To identify risk factors of SARS-CoV-2 infection in a rural Sub Saharan setting

  1 year

Study Arms (1)

cohort

sero-surveillance will start in a cohort of 800 adults (18-50y). In case of an established outbreak, this sample will be extended to 400 children (0-17y) and 400 elderly (50+y).

Biological: serological surveillance

Interventions

serological surveillance BIOLOGICAL

serological surveillance, detection of antibodies (Total Ig and IgM) developed against SARS-CoV-2 in a population living in a rural area (Kimpese, DRC)

cohort

Eligibility Criteria

• Age: 1 Month - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study site will be the Health Demographic Surveillance System (HDSS) in the health district of Kimpese, Kongo-Central province, DRC, managed by Centre de Recherche en Santé de Kimpese (CRSK). Each village, household and household member is listed in the HDSS database, each household has been geo-referenced. The HDSS has enrolled a cohort of 60 000 inhabitants in 11 rural health areas of the district. Up to now, this area has not declared any COVID-19 cases. The IME hospital of Kimpese has been designated for the hospitalisation and medical care of COVID-19 suspect and confirmed cases and the outbreak response team has been established

You may qualify if:

• In order to be eligible for the sero-survey, study participants must meet the following criteria:
• Resident of the Kimpese HDSS demographic surveillance area
• Adults 18-50 years old
• When SARS-CoV-2 transmission is confirmed, all ages will be eligible to participate
• Willing and able to provide written informed consent
• In order to be eligible for the social-mixing survey, study participants must meet the following criteria:
• Resident of the Kimpese HDSS demographic surveillance area
• Willing and able to provide written informed consent

You may not qualify if:

• refusal to participation

Sponsors & Collaborators

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

Study Sites (1)

Centre de Recherche en Santé de Kimpese

Kimpese, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Raquel Inocencio da Luz, PhD

  Insitute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: September 23, 2020
• Primary Completion: December 31, 2021
• Study Completion: September 30, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

DE (1)