Skip to main content
OpenTrials
Completed

NCT Number: NCT04442165

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

INS

Maputo, Mozambique

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Exclusion Criteria

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Institut de Recherche pour le Developpement
  • Instituto Nacional de Saúde, Mozambique
  • UMC Utrecht

Registry information

Official study title

Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance

Acronym: AfriCoVER

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.