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临床试验/NCT04442165
NCT04442165已完成不适用

Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance

Institute of Tropical Medicine, Belgium1 个研究点 分布在 1 个国家目标入组 6,049 人开始时间: 2020年12月15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
6,049
试验地点
1
主要终点
COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month)

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

COVID-19 Disease Incidence Rate (Symptomatic Infections Per Month)

时间窗: 12 months

Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo

COVID-19 Related Hospitalization Rate Due to SARS-CoV-2

时间窗: 12 months

Estimate the hospitalization rate related to SARS-CoV-2 over a 12 month period in peri-urban Maputo

Case (Disease) Fatality Risk (Percent) Due to SARS-CoV-2

时间窗: 12 months

Estimate the COVID-19 case fatality of cases detected during a 12 month period in peri-urban Maputo. A part of the cases (92) was followed up until 28 days, a part (54) until 56 days.

Percentage Asymptomatic Infections

时间窗: 12 months

Estimate the percentage of infections that are asymptomatic.This percentage is not available by age group. The percentage comes from combining 2 measures: the incidence rates (per age groups) with the overal incidence rate of SARS-CoV-2 infection in the first 6 months of the study, inferred from the change in sero-prevalence

Percentagge of Participants With SARS-CoV-2 Infection Annually

时间窗: 6 months

Estimate the attack rate of SARS-CoV-2 infection during 6 months in peri-urban Maputo. Crude sero-prevalence among study participants.

次要结局

未报告次要终点

研究者

发起方
Institute of Tropical Medicine, Belgium
申办方类型
Other
责任方
Sponsor

研究点 (1)

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