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

November 10, 2022 updated by: Institute of Tropical Medicine, Belgium

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The sero-surveillance will start in a cohort of 800 adults (18-50y). In case of an established outbreak, this sample will be extended to 800 pre-school children (0-5y), 800 schoolchildren (6-17y) and elderly (50+y). Human interactions will be quantified for the rural context of Kimpese in four age categories, pre-school children (0-5y), schoolchildren (6-17y), adults (18-50y) and elderly (50+). A sample of 300 persons in each age group will be selected.

The study site will be the Health Demographic Surveillance System (HDSS) in the health district of Kimpese, Kongo-Central province, DRC, managed 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. CRSK is the partner involved in the study and from the core database the cohort population for the study will be selected using two stage sampling. In stage one 20 villages will be randomly selected from the HDSS database using population size as sampling weight. In stage two a random sample of 40 eligible individuals will be drawn in each of the selected villages.

In the cohort, a blood sample will be collected for serology (sero-surveillance). When an individual presents seroconversion, the household attack rate will be explored. Information on symptoms and one serum sample of each household member, irrespective of age, will be requested during the next follow-up visit. Any study subject reporting symptoms or presenting with a fever, will be referred to the Institut Médical Evangélique (IME) hospital for appropriate medical care.

A social mixing survey will be carried out to assess human contact behaviour, in an extended cohort involving four age groups (0-5 years; 6-17 years; 18-50 years; >50 years old), sampled from the overall population in rural Kimpese.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1709

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal to participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
serological surveillance, detection of antibodies (Total Ig and IgM) developed against SARS-CoV-2 in a population living in a rural area (Kimpese, DRC)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To predict and monitor the transmission of SARS-CoV-2 in a rural Sub Saharan setting.
Time Frame: 1 year
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.
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To create social contact matrices that can be used to parameterise dynamic transmission models.
Time Frame: 1 year
To assess the change in social mixing patterns following the introduction of COVID-19 related physical distancing measures
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To identify risk factors of SARS-CoV-2 infection in a rural Sub Saharan setting
Time Frame: 1 year
The combination of sero-surveillance and social mixing results will provide elements for 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Tropical Medicine, Belgium

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Centre de Recherche en Santé de Kimpese

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raquel Inocencio da Luz, PhD, Insitute of Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B3002020000141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on serological surveillance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings