Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique

NCT04442165 | Completed Results

• 1 other identifier: AfriCoVER
• Study Type: observational
• Target: 6,049
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Instituto Nacional de Saúde, Mozambique: collaborator
• Institut de Recherche pour le Developpement: collaborator
• UMC Utrecht: collaborator

Study Sites (1)

INS

Maputo, Mozambique

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Nasal swabs (for all possible Covid-19cases) * Dried Blood Spots (only in a subset of the population, 2400 individuals)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Brecht Ingelbeen
• Organization: Insitute of Tropical Medicine

bingelbeen@itg.be

+32(0)33455787

Study Officials

• Marc-Alain Widdowson, Dr

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: December 15, 2020
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: March 6, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-02

Locations

MO (1)