Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
| Instituto Nacional de Saúde, Mozambique | OTHER_GOV |
| Institut de Recherche pour le Developpement | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month) | Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo | 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 | 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. | 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 | 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. | 6 months |
Not provided
Not provided
Inclusion Criteria:
No Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc-Alain Widdowson, Dr | Institute of Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INS | Maputo | Mozambique |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
During December 2020-March 2022, households of a population cohort in Polana Caniço, Maputo, Mozambique, were visited or phoned biweekly. Residents reporting any respiratory sign, anosmia, or ageusia, was asked to self-administer a nasal swab, for SARS-CoV-2 PCR testing. Of a subset of 1400 participants, dried blood spots were repeatedly collected, three-monthly, from fingerpicks at home.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants Visited | During 11925 household visits in 1561 households 6049 participants were covered |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort Participants | Screened/visited Participants, not having self-reported first confirmed COVID-19 episodes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month) | Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo | Posted | Number | 95% Confidence Interval | infections per 1000 person-years | 12 months |
|
|
As there is no investigational product in this study, adverse events were not monitored/assessed. Death was followed up in COVID cases for 56 days.
As there is no investigational product in this study, adverse events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants Visited | all participants that were visited throughout the study |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brecht Ingelbeen | Insitute of Tropical Medicine | +32(0)33455787 | bingelbeen@itg.be |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2021 | Dec 20, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| UMC Utrecht | OTHER |
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Socio-economic quintile | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Health worker Reported comorbidities | Count of Participants | Participants |
|
| BMI | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Public transportation | Count of Participants | Participants |
|
| Sharing bedroom | Count of Participants | Participants |
|
| Sharing toilet with other household | Count of Participants | Participants |
|
| Handwash facility | Count of Participants | Participants |
|
| Water available in house | Count of Participants | Participants |
|
|
| Primary | 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 | confirmed COVID-19 cases followed up at day 28 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | 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. | 92 confirmed cases followed up after 28 days, of whom 54 again after 56 days | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | 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 | Posted | Number | percentage of infections | 12 months |
|
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| 1 |
| 92 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |