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

COVID-19 Clinical Trial

— MozCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05228639
• Other study ID #: 80/CNBS/20
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: Centro de Investigacao em Saude de Manhica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6494
• Est. completion date: August 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria The study has five components and therefore the inclusion criteria may vary from one component to another.

1. 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.

2. 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.

3. 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.

4. Natural history of SARS-CoV-2 infection

• Participants who fulfill eligibility criteria for activity a) and with laboratory-confirmed SARS-CoV-2 infection.

5. Clinical presentation and factors associated with SARS-CoV-2 • Participants who fulfill eligibility criteria for activities a) and c). Exclusion Criteria

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Mozambique	Centro de investigacao em saude de Manhica	Manhica

Sponsors (6)

Lead Sponsor	Collaborator
Centro de Investigacao em Saude de Manhica	Barcelona Institute for Global Health, Imperial College London, Instituto de Biomedina de Valencia, IBV, Instituto Nacional de Saúde, Mozambique, World Health Organization

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	COVID-19 associated mortality	Factors associated with acute COVID-19, sero-positivity and COVID-19 associated mortality	2 years
Secondary	PCR and antibody-negativization	Median time (weeks or months) to PCR and antibody-negativization in symptomatic PCR-confirmed acute COVID-19 individuals	up to 12 months
Secondary	Relatedness of SARS-CoV-2 genome	Monophyletic groups of closely related SARS-CoV-2 genome	15 months