Covid19DynaCovidNCT04701996
Transmission Dynamics of COVID-19 in a Rural Setting of the Democratic Republic of the Congo
An observational study of Covid19, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- serological surveillance
- How many people
- 1,709 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 23 Sep 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- refusal to participation
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Centre de Recherche en Santé de Kimpese
Kimpese
About this study
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- serological surveillance
- Keywords
- serological test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serological surveillanceBiological
serological surveillance, detection of antibodies (Total Ig and IgM) developed against SARS-CoV-2 in a population living in a rural area (Kimpese, DRC)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: serological surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
To create social contact matrices that can be used to parameterise dynamic transmission models.
To assess the change in social mixing patterns following the introduction of COVID-19 related physical distancing measures
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start23 Sep 2020
- Primary completion31 Dec 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,709 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Santé de Kimpese, Institut National de Recherche Biomedicale (INRB)
- Responsible party
- Sponsor
- Investigators
- Raquel Inocencio da Luz, PhD, Principal investigator, Insitute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701996
- Sponsor's protocol ID
- B3002020000141
- Acronym
- DynaCovid
- Status last verified
- Nov 2022
- First submitted
- 6 Jan 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission Dynamics of COVID-19 in a Rural Setting of the Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT04701996
- Acronym / sponsor ID
- DynaCovid / B3002020000141
- Conditions
- Covid19
- Keywords
- serological test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,709 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Centre de Recherche en Santé de Kimpese, Institut National de Recherche Biomedicale (INRB)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Biological: serological surveillancesero-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). |
Who may qualify
- Ages
- 1 month to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- refusal to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serological surveillanceserological surveillance, detection of antibodies (Total Ig and IgM) developed against SARS-CoV-2 in a population living in a rural area (Kimpese, DRC) | Biological | cohort |
Primary outcome
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)
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 secondary outcome
To create social contact matrices that can be used to parameterise dynamic transmission models.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Inocencio da Luz, PhD principal investigator
Insitute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To predict and monitor the transmission of SARS-CoV-2 in a rural Sub Saharan setting. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.