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

NCT05228639 | Completed DMC

• 1 other identifier: 80/CNBS/20
• Study Type: observational
• Target: 6,494
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

COVID-19

Keywords

SARS-CoV-2 infection; Epidemiology; Diagnostic; Surveillance; Serosurvey

Outcome Measures

Primary Outcomes (6)

• 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

  15 months

• 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

  15 months

• 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

  month 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

  month 11

• 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

  month 14

• COVID-19 associated mortality

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

  2 years

Secondary Outcomes (2)

• PCR and antibody-negativization

  up to 12 months

• Relatedness of SARS-CoV-2 genome

  15 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

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.

You may qualify if:

• COVID-19 morbidity surveillance
• Individuals of any age admitted to MDH or pregnant attending the Maragra health center meet the COVID-19 case definition as defined above after the project start date.
• Resident of Manhiça DSS area
• Written informed consent from a parent or guardian if a child, and from participant if an adult prior recruitment.
• COVID-19 mortality surveillance • All deaths in children under the age of 5 (including stillbirths), occurring at the health facility or at the community; • In hospital adult deaths occurring at the MDH;
• Resident of Manhiça DSS area;
• Written informed consent from the relative of the dead person.
• COVID-19 population-based serosurveys • Individuals of all age groups residing in Manhiça DSS surveillance area • Signed informed parental permission from a parent or guardian if a child and from participant if an adult.
• Natural history of SARS-CoV-2 infection
• Participants who fulfill eligibility criteria for activity a) and with laboratory-confirmed SARS-CoV-2 infection.
• Clinical presentation and factors associated with SARS-CoV-2 • Participants who fulfill eligibility criteria for activities a) and c).

You may not qualify if:

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

Sponsors & Collaborators

• Centro de Investigacao em Saude de Manhica: lead
• Barcelona Institute for Global Health: collaborator
• Imperial College London: collaborator
• Instituto Nacional de Saúde, Mozambique: collaborator
• Instituto de Biomedina de Valencia, IBV: collaborator
• World Health Organization: collaborator

Study Sites (1)

Centro de investigacao em saude de Manhica

Manhiça, Mozambique

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs to detect SARS-CoV-2, blood, feces, and saliva samples are being collect from the study participants.

MeSH Terms

Conditions

COVID-19; Disease

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 8, 2022
• Study Start: December 1, 2020
• Primary Completion: July 30, 2022
• Study Completion: August 31, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

MO (1)