COVID-19
Conditions
Brief 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 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.
Interventions
None listed
Sponsors
European and Developing Countries Clinical Trials Partnership (EDCTP)
Instituto Nacional de Saúde, Mozambique
Institut de Recherche pour le Developpement
UMC Utrecht
Institute of Tropical Medicine, Belgium
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month) | 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 | 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 | 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 | 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 | 6 months | Estimate the attack rate of SARS-CoV-2 infection during 6 months in peri-urban Maputo. Crude sero-prevalence among study participants. |
Countries
Mozambique
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cohort Participants Screened/visited Participants, not having self-reported first confirmed COVID-19 episodes | 6,049 |
| Total | 6,049 |
Baseline characteristics
| Characteristic | Cohort Participants | — |
|---|---|---|
| Age, Customized 0-9 years | 1331 Participants | — |
| Age, Customized 10-19 years | 1570 Participants | — |
| Age, Customized 20-29 years | 1128 Participants | — |
| Age, Customized 30-39 years | 644 Participants | — |
| Age, Customized 40-49 years | 519 Participants | — |
| Age, Customized 50-59 years | 406 Participants | — |
| Age, Customized 60-69 years | 318 Participants | — |
| Age, Customized ≥70 years | 133 Participants | — |
| BMI normal | 802 Participants | — |
| BMI obesity | 237 Participants | — |
| BMI overweight | 281 Participants | — |
| BMI underweight | 817 Participants | — |
| BMI unknown | 3912 Participants | — |
| Education higher | 277 Participants | — |
| Education none | 88 Participants | — |
| Education primary | 2646 Participants | — |
| Education secondary | 1735 Participants | — |
| Education unknown | 1303 Participants | — |
| Handwash facility bucket/jar/kettle | 1204 Participants | — |
| Handwash facility none | 3005 Participants | — |
| Handwash facility sink/faucet | 1748 Participants | — |
| Handwash facility unknown | 92 Participants | — |
| Health worker Reported comorbidities no reported comorbidities | 5853 Participants | — |
| Health worker Reported comorbidities reported comorbidities | 196 Participants | — |
| Public transportation bus/train | 2013 Participants | — |
| Public transportation moto taxi/shared taxi | 19 Participants | — |
| Public transportation None | 3948 Participants | — |
| Public transportation unknown | 69 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 3245 Participants | — |
| Sex: Female, Male Male | 2804 Participants | — |
| Sharing bedroom 1-2 pers. | 3311 Participants | — |
| Sharing bedroom 3 or more pers. | 2646 Participants | — |
| Sharing bedroom unknown | 92 Participants | — |
| Sharing toilet with other household no sharing toilet or not recorded | 5153 Participants | — |
| Sharing toilet with other household sharing toilet | 896 Participants | — |
| Smoking (ex) smoker | 251 Participants | — |
| Smoking Non smoker | 5738 Participants | — |
| Smoking unknown | 60 Participants | — |
| Socio-economic quintile highest | 1132 Participants | — |
| Socio-economic quintile Low | 1015 Participants | — |
| Socio-economic quintile Lowest | 836 Participants | — |
| Socio-economic quintile Med | 1063 Participants | — |
| Socio-economic quintile Med/high | 1078 Participants | — |
| Socio-economic quintile unknown | 925 Participants | — |
| Water available in house no | 3804 Participants | — |
| Water available in house unknown | 92 Participants | — |
| Water available in house Yes | 2153 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 92 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 12 months
Population: 92 confirmed cases followed up after 28 days, of whom 54 again after 56 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Persons Followed up | Case (Disease) Fatality Risk (Percent) Due to SARS-CoV-2 | 1 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Persons Followed up | COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month) | 364.5 infections per 1000 person-years |
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
Time frame: 12 months
Population: confirmed COVID-19 cases followed up at day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Persons Followed up | COVID-19 Related Hospitalization Rate Due to SARS-CoV-2 | 0 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Persons Followed up | Percentage Asymptomatic Infections | 86.6 percentage of infections |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Persons Followed up | Percentagge of Participants With SARS-CoV-2 Infection Annually | in June 2021, when 3.0% of participants was vaccinated with at least one dose of vaccine | 34.7 percentage of participants |
| Persons Followed up | Percentagge of Participants With SARS-CoV-2 Infection Annually | in December 2020 | 4.8 percentage of participants |