COVID-19AfriCoVERNCT04442165
Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique
An observational study of COVID-19, run by Institute of Tropical Medicine, Belgium at 1 site in Mozambique.
Trial summary
A population-based COVID19 surveillance in a household cohort will be set-up using an existing Household demographic surveillance system (HDSS). From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 6,049 participants
- Where
- 1 siteMozambique
- Study dates
- 15 Dec 2020to 29 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The Polana Caniço-HDSS (Health- and Demographic Surveillance System) has been established since 2017. In total, 2108 households (defined as residents of the same building, sharing a cooking area) have been enrolled in the HDSS. All members residing in the household for at least 3 months (infants, children, adults, elderly) are enrolled in the HDSS. All households in the HDSS (2108 during the last round, in 2019) consenting to participate in the study will be visited biweekly by a trained HDSS interviewer, following the same procedures as in routine HDSS rounds, specified in the HDSS protocol (Instituto Nacional de Saude, 2016). We assume the same number of households will consent to participate as in other HDSS rounds.
Who may be able to join
- Any individual enrolled in the Polana Caniço-HDSS: All members residing in the household for at least 3 months (infants, children, adults, elderly), regardless of age, underlying conditions, medical history, infection or disease status or history
- Able and willing to provide written informed consent: by the household head for the surveillance; by each selected participant for the sero-survey.
- No Exclusion Criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance
A population-based COVID19 surveillance in a household cohort will be set-up using an existing Household demographic surveillance system (HDSS). From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus, during 12 months. Demographic, epidemiological and clinical data of possible cases and of the source population will be recorded at baseline.
An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.
Read the detailed description
The investigators will use the established HDSS to set up population-based COVID19 surveillance in a household cohort. From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus by PCR, during 12 months. These cases will be identified through bi-weekly household visits, through an alert system involving community leaders and HDSS interviewers, or when presenting with symptoms at healthcare centres or the referral hospital. Demographic, epidemiological and clinical data (comorbidities, medication, obesity, HIV, TB, smoking) of possible cases and of the source population will be recorded at baseline; recent illness, potential risk exposure of each household member (including duration and type) to SARS-CoV-2 positive individuals, uptake of measures to reduce exposure/transmission, and barriers to the uptake of such measures, will be recorded/updated during every household visit.
An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month)
Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo
Measured: 12 months
COVID-19 Related Hospitalization Rate Due to SARS-CoV-2
Estimate the hospitalization rate related to SARS-CoV-2 over a 12 month period in peri-urban Maputo
Measured: 12 months
Case (Disease) Fatality Risk (Percent) Due to SARS-CoV-2
Estimate the COVID-19 case fatality of cases detected during a 12 month period in peri-urban Maputo.
A part of the cases (92) was followed up until 28 days, a part (54) until 56 days.
Measured: 12 months
Percentage Asymptomatic Infections
Estimate the percentage of infections that are asymptomatic.This percentage is not available by age group. The percentage comes from combining 2 measures: the incidence rates (per age groups) with the overal incidence rate of SARS-CoV-2 infection in the first 6 months of the study, inferred from the change in sero-prevalence
Measured: 12 months
Percentagge of Participants With SARS-CoV-2 Infection Annually
Estimate the attack rate of SARS-CoV-2 infection during 6 months in peri-urban Maputo. Crude sero-prevalence among study participants.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start15 Dec 2020
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies 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
- 6,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Instituto Nacional de Saúde, Mozambique, Institut de Recherche pour le Developpement, UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Marc-Alain Widdowson, Dr, Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442165
- Sponsor's protocol ID
- AfriCoVER
- Acronym
- AfriCoVER
- Status last verified
- Feb 2025
- First submitted
- 16 Jun 2020
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance
- ClinicalTrials.gov ID
- NCT04442165
- Acronym / sponsor ID
- AfriCoVER / AfriCoVER
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,049 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Instituto Nacional de Saúde, Mozambique, Institut de Recherche pour le Developpement, UMC Utrecht
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A population-based COVID19 surveillance in a household cohort will be set-up using an existing Household demographic surveillance system (HDSS). From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus, during 12 months. Demographic, epidemiological and clinical data of possible cases and of the source population will be recorded at baseline.
An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.
Detailed description
The investigators will use the established HDSS to set up population-based COVID19 surveillance in a household cohort. From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus by PCR, during 12 months. These cases will be identified through bi-weekly household visits, through an alert system involving community leaders and HDSS interviewers, or when presenting with symptoms at healthcare centres or the referral hospital. Demographic, epidemiological and clinical data (comorbidities, medication, obesity, HIV, TB, smoking) of possible cases and of the source population will be recorded at baseline; recent illness, potential risk exposure of each household member (including duration and type) to SARS-CoV-2 positive individuals, uptake of measures to reduce exposure/transmission, and barriers to the uptake of such measures, will be recorded/updated during every household visit.
An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Polana Caniço-HDSS (Health- and Demographic Surveillance System) has been established since 2017. In total, 2108 households (defined as residents of the same building, sharing a cooking area) have been enrolled in the HDSS. All members residing in the household for at least 3 months (infants, children, adults, elderly) are enrolled in the HDSS. All households in the HDSS (2108 during the last round, in 2019) consenting to participate in the study will be visited biweekly by a trained HDSS interviewer, following the same procedures as in routine HDSS rounds, specified in the HDSS protocol (Instituto Nacional de Saude, 2016). We assume the same number of households will consent to participate as in other HDSS rounds.
Key inclusion criteria (3 listed)
- Any individual enrolled in the Polana Caniço-HDSS: All members residing in the household for at least 3 months (infants, children, adults, elderly), regardless of age, underlying conditions, medical history, infection or disease status or history
- Able and willing to provide written informed consent: by the household head for the surveillance; by each selected participant for the sero-survey.
- No Exclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month)
Time frame: 12 months
Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo
COVID-19 Related Hospitalization Rate Due to SARS-CoV-2
Time frame: 12 months
Estimate the hospitalization rate related to SARS-CoV-2 over a 12 month period in peri-urban Maputo
Case (Disease) Fatality Risk (Percent) Due to SARS-CoV-2
Time frame: 12 months
Estimate the COVID-19 case fatality of cases detected during a 12 month period in peri-urban Maputo. A part of the cases (92) was followed up until 28 days, a part (54) until 56 days.
Percentage Asymptomatic Infections
Time frame: 12 months
Estimate the percentage of infections that are asymptomatic.This percentage is not available by age group. The percentage comes from combining 2 measures: the incidence rates (per age groups) with the overal incidence rate of SARS-CoV-2 infection in the first 6 months of the study, inferred from the change in sero-prevalence
Percentagge of Participants With SARS-CoV-2 Infection Annually
Time frame: 6 months
Estimate the attack rate of SARS-CoV-2 infection during 6 months in peri-urban Maputo. Crude sero-prevalence among study participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Marc-Alain Widdowson, Dr principal investigator
Institute 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 COVID-19, run by Institute of Tropical Medicine, Belgium at 1 site in Mozambique.
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 3 inclusion and 0 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 6 Mar 2025. 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 Mozambique. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month) (time frame: 12 months). The study lists 5 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 6 Mar 2025.