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

Sponsor
Institute of Tropical Medicine, Belgium (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04442165
Collaborator
European and Developing Countries Clinical Trials Partnership (EDCTP) (Other), Instituto Nacional de Saude, Mozambique (Other), Institut de Recherche pour le Developpement (Other), UMC Utrecht (Other)
15,393
1
21.5
716.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    15393 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance
    Actual Study Start Date :
    Dec 15, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. Proportion asymptomatic infections, by age group [12 months]

      Estimate the proportion of infections that are asymptomatic, by age group

    5. SARS-CoV-2 infection annual attack rate (percent) [12 months]

      Estimate the attack rate of SARS-CoV-2 infection during 12 months in peri-urban Maputo

    6. SARS-CoV-2 infection fatality risk [12 months]

      Estimate the SARS-CoV-2 infection fatality of infections detected during a 12 month period in peri-urban Maputo

    7. Infection fatality of SARS-CoV-2 infection. [12 months]

      Estimate the infection fatality of SARS-CoV-2 infection in peri-urban Maputo.

    8. Serial interval number of SARS-CoV-2 infection [12 months]

      Estimate the serial interval number of SARS-CoV-2 infection in peri-urban Maputo.

    9. Reproduction number of SARS-CoV-2 infection [12 months]

      Estimate the reproduction number of SARS-CoV-2 infection in peri-urban Maputo.

    Secondary Outcome Measures

    1. Correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection [12 months]

      Analyze the correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection

    2. Antibody titers against SARS-CoV-2 over time [12 months]

      Measure antibody titers against SARS-CoV-2 over time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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 Exclusion Criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 INS Maputo Mozambique

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Marc-Alain Widdowson, Dr, Institute of Tropical Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of Tropical Medicine, Belgium
    ClinicalTrials.gov Identifier:
    NCT04442165
    Other Study ID Numbers:
    • AfriCoVER
    First Posted:
    Jun 22, 2020
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 23, 2022