Trial Outcomes & Findings for Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique (NCT NCT04442165)

NCT ID: NCT04442165

Last Updated: 2025-03-06

Results Overview

Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo

• Recruitment status: COMPLETED
• Target enrollment: 6049 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-03-06

Participant Flow

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.

Participant milestones

Measure	All Participants Visited During 11925 household visits in 1561 households 6049 participants were covered
Overall Study STARTED	6049
Overall Study Participants Undergoing a Nasal Swab	579
Overall Study Participants Undergoing Dry Blood Spot Collection	1412
Overall Study COMPLETED	6049
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cohort Participants n=6049 Participants Screened/visited Participants, not having self-reported first confirmed COVID-19 episodes
Age, Customized 0-9 years	1331 Participants n=6049 Participants
Age, Customized 10-19 years	1570 Participants n=6049 Participants
Age, Customized 20-29 years	1128 Participants n=6049 Participants
Age, Customized 30-39 years	644 Participants n=6049 Participants
Age, Customized 40-49 years	519 Participants n=6049 Participants
Age, Customized 50-59 years	406 Participants n=6049 Participants
Age, Customized 60-69 years	318 Participants n=6049 Participants
Age, Customized ≥70 years	133 Participants n=6049 Participants
Sex: Female, Male Female	3245 Participants n=6049 Participants
Sex: Female, Male Male	2804 Participants n=6049 Participants
Socio-economic quintile Lowest	836 Participants n=6049 Participants
Socio-economic quintile Low	1015 Participants n=6049 Participants
Socio-economic quintile Med	1063 Participants n=6049 Participants
Socio-economic quintile Med/high	1078 Participants n=6049 Participants
Socio-economic quintile highest	1132 Participants n=6049 Participants
Socio-economic quintile unknown	925 Participants n=6049 Participants
Education none	88 Participants n=6049 Participants
Education primary	2646 Participants n=6049 Participants
Education secondary	1735 Participants n=6049 Participants
Education higher	277 Participants n=6049 Participants
Education unknown	1303 Participants n=6049 Participants
Health worker Reported comorbidities reported comorbidities	196 Participants n=6049 Participants
Health worker Reported comorbidities no reported comorbidities	5853 Participants n=6049 Participants
BMI underweight	817 Participants n=6049 Participants
BMI normal	802 Participants n=6049 Participants
BMI overweight	281 Participants n=6049 Participants
BMI obesity	237 Participants n=6049 Participants
BMI unknown	3912 Participants n=6049 Participants
Smoking Non smoker	5738 Participants n=6049 Participants
Smoking (ex) smoker	251 Participants n=6049 Participants
Smoking unknown	60 Participants n=6049 Participants
Public transportation None	3948 Participants n=6049 Participants
Public transportation bus/train	2013 Participants n=6049 Participants
Public transportation moto taxi/shared taxi	19 Participants n=6049 Participants
Public transportation unknown	69 Participants n=6049 Participants
Sharing bedroom 1-2 pers.	3311 Participants n=6049 Participants
Sharing bedroom 3 or more pers.	2646 Participants n=6049 Participants
Sharing bedroom unknown	92 Participants n=6049 Participants
Sharing toilet with other household sharing toilet	896 Participants n=6049 Participants
Sharing toilet with other household no sharing toilet or not recorded	5153 Participants n=6049 Participants
Handwash facility sink/faucet	1748 Participants n=6049 Participants
Handwash facility bucket/jar/kettle	1204 Participants n=6049 Participants
Handwash facility none	3005 Participants n=6049 Participants
Handwash facility unknown	92 Participants n=6049 Participants
Water available in house Yes	2153 Participants n=6049 Participants
Water available in house no	3804 Participants n=6049 Participants
Water available in house unknown	92 Participants n=6049 Participants

PRIMARY outcome

Timeframe: 12 months

Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo

Outcome measures

Measure	Persons Followed up n=6049 Participants During 11925 household visits in 1561 households, covering 6049 participants
COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month)	364.5 infections per 1000 person-years Interval 352.8 to 376.1

PRIMARY outcome

Timeframe: 12 months

Population: confirmed COVID-19 cases followed up at day 28

Estimate the hospitalization rate related to SARS-CoV-2 over a 12 month period in peri-urban Maputo

Outcome measures

Measure	Persons Followed up n=85 Participants During 11925 household visits in 1561 households, covering 6049 participants
COVID-19 Related Hospitalization Rate Due to SARS-CoV-2	0 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 92 confirmed cases followed up after 28 days, of whom 54 again after 56 days

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.

Outcome measures

Measure	Persons Followed up n=92 Participants During 11925 household visits in 1561 households, covering 6049 participants
Case (Disease) Fatality Risk (Percent) Due to SARS-CoV-2	1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Persons Followed up n=85 Participants During 11925 household visits in 1561 households, covering 6049 participants
Percentage Asymptomatic Infections	86.6 percentage of infections

PRIMARY outcome

Timeframe: 6 months

Estimate the attack rate of SARS-CoV-2 infection during 6 months in peri-urban Maputo. Crude sero-prevalence among study participants.

Outcome measures

Measure	Persons Followed up n=1412 Participants During 11925 household visits in 1561 households, covering 6049 participants
Percentagge of Participants With SARS-CoV-2 Infection Annually in December 2020	4.8 percentage of participants Interval 1.1 to 8.6
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 Interval 20.2 to 49.3

Adverse Events

All Participants Visited

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brecht Ingelbeen

Insitute of Tropical Medicine

Phone: +32(0)33455787

Email: bingelbeen@itg.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place