A Prospective Household Study of SARS-CoV-2, Influenza, and Respiratory Syncytial Virus Community Burden, Transmission Dynamics and Viral Interaction in South Africa (the PHIRST-C Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Describe the symptomatic fraction of SARS-CoV-2 infections among individuals in household cohort in an rural and urban setting, South Africa 2020/2021.
研究概览
简要总结
The study aims to characterize the community burden (including the clinical features) and transmissibility of SARS-CoV-2 within the context of a functional antibody response. In addition,the study will assess the effect of the interaction of SARS-CoV-2 with influenza virus and RSV on disease severity and transmission dynamics. A household-level prospective cohort study will be conducted in one rural and one urban community located in Mpumalanga Province and North West Province, respectively. The study will be conducted for 12 months of intensive follow up (July 2020 to August 2021) with a post-intensive follow-up continuing for a further 16 months (until December 2022). Two hundred households; 1,000 study participants of all ages; will be randomly selected from a list of 327 hoseholds that participated and successfully completed a 10-months follow-up period in a study similar to that currently proposed, but directed at community burden and transmission dynamics of influenza, respiratory syncytial virus and other respiratory pathogens. Each household and household member will be enumerated and the HIV infection status and the level of immunosuppression of HIV-infected individuals will be assessed. Each household member will be followed twice per week during the intense follow-up period (12 months) of the study. During this period upper respiratory tract samples will be collected irrespective of presence of symptoms and data on key symptoms, healthcare seeking, hospitalization and death will be captured at each follow up visit. Respiratory samples will be tested by reverse transcriptase real-time polymerase chain reaction (rRT-PCR) for SARS-CoV-2, influenza and RSV, and selected samples will be cultured and sequenced. An infection risk questionnaire will be administered to all study participants at enrollment and every month thereafter. Sera will be collected at enrollment and every 2 months during the 12-month intense follow-up period from all participants. In addition, sera will be collected every 2 months for a further 6 months following the 12-month intense follow-up period from study participants that tested positive for SARS-CoV-2 by rRT-PCR on respiratory specimens at 14, 16 and 18 months and from all study participants at 18 months. Sera will be tested for the presence of SARS-CoV-2, influenza and RSV antibodies. Wearable proximity sensors will be deployed for 8-12 days in each household over the 6-month intense follow-up period.
详细描述
Background and justification: On 31 December 2019, the World Health Organization (WHO) was alerted to a cluster of pneumonia cases of unknown etiology in patients in Wuhan City, Hubei Province of China, which, one week later, was attributed to a novel coronavirus (severe acute respiratory syndrome coronavirus 2: SARS-CoV-2). Given its rapid spread globally, WHO declared that the outbreak of SARS-CoV-2 met pandemic criteria on 11th March 2020. By mid-April 2020 more than 2.5 million cases and more than 170,000 deaths have been laboratory-confirmed in 210 countries and territories.
Influenza virus is responsible for elevated morbidity and mortality globally every year. In South Africa annual seasonal influenza epidemics occur during the winter months (May-October, with peak transmission in June-July) and result in an estimated 19 million symptomatic infections, 128,000 severe cases and 11,000 deaths on average every year.
Human respiratory syncytial virus (RSV) is the commonest cause of childhood acute lower respiratory tract infection, especially among infants <3 months of age. In South Africa RSV circulates throughout the year with peak transmission occurring usually during February-April. Nonetheless, from systematic virologic surveillance data delayed RSV transmission is expected to occur in South Africa in 2020. This has the potential to result in concomitant SARS-CoV-2, influenza and RSV peak transmission in the country.
HIV incidence remains high in South Africa. Similarly, rates of pulmonary tuberculosis (PTB), with concomitant damage to lung tissue, remain persistently high despite concerted national efforts. HIV and PTB infections have been associated with an increased risk of severe illness (i.e., hospitalization and death) following infection with common respiratory pathogens, including influenza and RSV, even among individuals on antiretroviral therapy.
Understanding the community burden, transmissibility potential and clinical features of illness associated with SARS-CoV-2 infection is critical to inform the design and duration of containment and mitigation measures, both locally and globally. An accurate estimation of risk factors for community transmission, acquisition and duration of infectiousness is crucial to inform guidance for public health measures to limit transmission as well as models for epidemic forecasting for this and potential future epidemics. Moreover, factors specific to South and sub-Saharan Africa (SSA) such as HIV, tuberculosis, high proportion of the population who are children, malnutrition, and limited healthcare resources have the potential to impact both the transmission dynamics, progression and prognosis of SARS-CoV-2 disease; as well as the burden on the healthcare system and society.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Households/individuals that consent to participate to the study; and that are planning to reside in the selected community for the duration of the study.
- •Provide at least one serum sample in the intensive follow up period, for individuals five years and older and
- •Households should have at least 3 or more.
排除标准
- •Households that:
- •Non-eligible households will be households that were not randomly selected, that were selected but did not consent to participate to the study or, that have >20% of household members who do not consent for inclusion in the study.
结局指标
主要结局
Describe the symptomatic fraction of SARS-CoV-2 infections among individuals in household cohort in an rural and urban setting, South Africa 2020/2021.
时间窗: 14 months
The proportion of SARS-CoV2 infection that are symptomatic. This will be stratified by age, underlying conditions, HIV infection.
Describe the incidence of infection by PCR and serology in a household cohort in a rural and urban setting, South Africa 2020/21
时间窗: 14 months
The number of new cases of symptomatic illness recorded by symptoms reported cohort over the 14 months of follow-up. Including estimating a person time to follow-up incident rate
Describe the incidence illness by PCR and/or serology in a household cohort in a rural and urban setting, South Africa 2020/21
时间窗: 14 months
Describe the incidence of infection by PCR and serology in a household cohort over 14 months of follow-up, in a rural and urban setting, South Africa 2020/21
Describe the household secondary infection risk of SARS-CoV-2 infection among individuals in a household cohort in an rural and urban setting, South Africa 2020/2021.
时间窗: 14 months
The number of secondary cases in a household divided by the total number of susceptible gives the secondary attack risk during the 14months of follow-up. This will be explored by underlying conditions, age and HIV status
Describe the serial interval for SARS-CoV-2 in households over 14 months of follow-up in an urban and rural setting, South Africa 2020/2021
时间窗: 14 months
Calculate the time between successive cases in a each household as documented by onset of symptoms and/or PCR positive test.
Describe the duration of shedding of SARS-CoV-2 in a household cohort in an rural and urban setting, South Africa 2020/2021.
时间窗: 14 month
The duration of PCR positive SARS-CoV-2 infection in individual over 14 months of follow-up, including describing the interval by age, HIV status and underlying conditions.
次要结局
未报告次要终点