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COVID-19MozCOVIDNCT05228639

COVID-19 Surveillance in Rural Mozambique for Prompt and Effective Response

An observational study of COVID-19, run by Centro de Investigacao em Saude de Manhica at 1 site in Mozambique.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Extraordinary times require extraordinary measures. The current COVID-19 pandemic is the paradigmatic example of how infectious diseases may menace the world's health and economy, and particularly contribute to enhancing current inequities in health-related to wealth. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
COVID-19
How many people
6,494 participants
Where
1 siteMozambique
Study dates
1 Dec 2020to 31 Aug 2022
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Manhiça district has a total population of 204,357 and 47.061 households and 27.560 children under five years. Each person living within the DSS study area is issued a unique Permanent Identification number that describes the geographic localization of his/her household. Some demographic indicators in 2015 are: a birth cohort of 3,946, life expectancy at birth 51 years, neonatal, infant, and under-five mortalities are 22.5/1,000 live births, 55.8 and 99.0, respectively. Children under the age of five represent 18% (29,700) of the total population.

Who may be able to join

None listed.

Who cannot join

  • Participation in an interventional clinical trial at the time of enrollment.

Trial locations and contacts

1 site in 1 country.

Mozambique1 site

  • Centro de investigacao em saude de Manhica

    Manhiça

Other trials in Mozambique

About this study

Official title: Coronavirus Disease 2019 Surveillance in Manhiça District Southern Mozambique for a Prompt and Effective Response Against the Epidemic

Extraordinary times require extraordinary measures. The current COVID-19 pandemic is the paradigmatic example of how infectious diseases may menace the world's health and economy, and particularly contribute to enhancing current inequities in health-related to wealth. The main goal of the proposed study is to understand the epidemiology and natural history of COVID-19 in a rural area in Southern Mozambique

Read the detailed description

Although Mozambique has so far had few confirmed cases of COVID19, it is unknown if low testing rates and other factors such as the warm climatic conditions may explain the apparently low spread of the virus. The present proposal aims to rapidly gain an understanding of the epidemic curve and natural history of SARS-CoV-2 in a rural area in southern Mozambique through a series of epidemiological indicators obtained at both the health facility and community levels, so as to provide evidence-based recommendations for managing and mitigating the COVID19 epidemic. Age-specific incidence of severe COVID-19 obtained at health facilities during a period of 15 months together with seroprevalence data obtained from the community will be used to determine SARS-CoV-2 reproduction number and effects of interventions through mathematical modeling. Viral, serological, and clinical progression will be assessed in a longitudinal cohort of symptomatic SARS-CoV-2 infected individuals. Community awareness of COVID-19 and of project aims will be fostered through engagement activities among community leaders and members. COVID-19 surveillance capacities in Mozambique will be strengthened by developing SARS-CoV-2 diagnostic approaches (molecular testing and an innovative immunoassay to detect antibodies against the virus), as well as SARS-CoV-2 genome sequencing approaches to identify transmission chains. Finally, the project will pursue the creation of a bank of serum, virus materials, and data which will be open for immediate public health purposes, including the development of point-of-care diagnostic tests. This project will be coordinated by the Manhiça Health Research Centre (Mozambique) in conjunction with the Barcelona Institute for Global Health (Spain), which will lead the transfer of molecular and immunological tools to the Mozambican research center. Imperial College will provide the modeling expertise to derive metrics of transmission, and INS the expertise to conduct quality control of laboratory determinations as well as dissemination and networking with the Ministry of Health in Mozambique. Four WPs will comprise the main research tasks, including COVID-19 surveillance (WP1), Laboratory determinations (WP2), Contact tracing and community awareness (WP3), Modelling (WP4), as well as two cross-cutting WPs related to Capacity-building (WP5) and Scientific coordination, management, networking \& dissemination (WP6). We expect this 21-month project will increase the level of preparedness, alertness, and response in Mozambique

Conditions
COVID-19
Keywords
SARS-CoV-2 infection, Epidemiology, Diagnostic, Surveillance, Serosurvey
Medical subject headings
COVID-19, Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age-specific positivity rate of SARS-CoV-2 infection

    Positivity rate by age-group (0-9, 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, >=70 years) of SARS-CoV-2 infection among acute respiratory syndrome individuals during 15 months

    Measured: 15 months

  2. Age-specific Incidence of SARS-CoV-2 infection

    Incidence by age-group (0-9. 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, >=70 years) of SARS-CoV-2 infection among acute respiratory syndrome individuals during 15 months

    Measured: 15 months

  3. Community Age-specific seroprevalence

    Seroprevalence by age-group (0-19, 20-39, 40-59, >=60 years) of IgM and IgG against SARS-CoV-2 at baseline andd after 15 months

    Measured: month 5

  4. Community Age-specific seroprevalence

    Seroprevalence by age-group (0-19, 20-39, 40-59, >=60 years) of IgM and IgG against SARS-CoV-2 at baseline andd after 15 months

    Measured: month 11

  5. Community Age-specific seroprevalence

    Seroprevalence by age-group (0-19, 20-39, 40-59, >=60 years) of IgM and IgG against SARS-CoV-2 at baseline andd after 15 months

    Measured: month 14

  6. COVID-19 associated mortality

    Factors associated with acute COVID-19, sero-positivity and COVID-19 associated mortality

    Measured: 2 years

Secondary outcomes (2)

  1. PCR and antibody-negativization

    Median time (weeks or months) to PCR and antibody-negativization in symptomatic PCR-confirmed acute COVID-19 individuals

    Measured: up to 12 months

  2. Relatedness of SARS-CoV-2 genome

    Monophyletic groups of closely related SARS-CoV-2 genome

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start1 Dec 2020
  3. Primary completion30 Jul 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
6,494 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05228639
Sponsor's protocol ID
80/CNBS/20
Acronym
MozCOVID
Status last verified
Aug 2023
First submitted
4 Feb 2022
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Centro de Investigacao em Saude de Manhica at 1 site in Mozambique.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age-specific positivity rate of SARS-CoV-2 infection (time frame: 15 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05228639.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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