跳至主要内容
临床试验/NCT05228639
NCT05228639已完成不适用

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

Centro de Investigacao em Saude de Manhica1 个研究点 分布在 1 个国家目标入组 6,494 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,494
试验地点
1
主要终点
COVID-19 associated mortality

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

COVID-19 associated mortality

时间窗: 2 years

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

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

时间窗: 15 months

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

Age-specific Incidence of SARS-CoV-2 infection

时间窗: 15 months

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

Community Age-specific seroprevalence

时间窗: month 14

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

次要结局

  • PCR and antibody-negativization(up to 12 months)
  • Relatedness of SARS-CoV-2 genome(15 months)

研究者

发起方
Centro de Investigacao em Saude de Manhica
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验