Italian Web-based EPICOVID19 Cross-sectional Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200,000
- 试验地点
- 1
- 主要终点
- Number of participants (%) with COVID-19-like symptoms
研究概览
简要总结
The outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that started in late December 2019 in the Hubei province of China caused millions of cases worldwide in just a few months, and evolved into a real pandemic.
However, only approximately 20% of SARS-CoV-2 infected patients required intensive on sub-intensice medical care and the remained experience mild or subclinical form of the disease that did not require hospital admission and a relatively high percentage (40 to 45%) remained asymptomatic.
Understanding the occurrence of SARS-CoV-2-like infectious in a large non-hospitalized population, when the epidemic peak was occurring in Italy, is of paramount importance but data are scarce.
The goal of this research project is to estimate the number of suspected cases of COVID-19 and to investigate the role of the potential factors associated with SARS-CoV-2 infection in a large Italian sample of respondents living in Italy during the lockdown (started in Italy on 9 March 2020).
EPICOVID19 is an Italian countrywide self-administered cross-sectional web-based survey on adult volunteers launched on April 13, 2020.
The on-line questionnaire has been developed starting from the available literature and implemented using an open source platform focusing on beahvioural and clinical features of participants.
详细描述
The COVID-19 pandemic is posing an unprecedented threat worldwide, which have been experiencing widespread transmission of the virus in the community for several weeks.
During the epidemic peak, epidemiological surveillance strategies were mainly based on the testing of symptomatic patients with serious diseases requiring hospitalization and intensive or sub-intensive medical care. This has underestimated the real spread of the infection in the mild symptomatic (paucisymptomatic) or asymptomatic individuals or in specific group of persons with limited access to testing.
EPICOVID19 was developed and launched to accomplish the following objectives: i) to estimate the number of suspected cases of COVID-19 in the general population, and ii) to investigate the role of the potential factors associated with SARS-CoV-2 infection in adult volunteers living in Italy during the lockdown.
EPICOVID19 is a national Italian anonymous self-administered internet-based survey that was carried out using a cross-sectional research design in a convenience sample of adult volunteers (18+ years old) living in Italy during the lockdown. The survey was launched on 13 April 2020.
In order to enrol as many subjects as possible, the link to the electronic survey was uploaded, shared and disseminated via several channels: e-mails, social media platforms (Facebook, Twitter, Instagram, Whatsapp), press releases, internet pages, local radio and TV stations, and institutional websites that called upon volunteers to contact the study website https://epicovid19.itb.cnr.it/.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age of >=18 years;
- •access to a mobile phone, computer, or tablet with internet connectivity;
- •on-line consent to participate in the study.
排除标准
- •age of <18 years;
- •without access to a mobile phone, computer, or tablet with internet connectivity;
- •not provide on-line consent to participate in the study.
结局指标
主要结局
Number of participants (%) with COVID-19-like symptoms
时间窗: 3 months (July 2020) after initial data collection (April 2020)
Measured by using answers on the Clinical evaluation section of the questionnaire: Fever \> 37.5 °C for at least 3 consecutive days; cough; sore throat/rhinorrea; headache; myalgia; olfactory/taste disorders; shortness of breath; chest pain; tachycardia; gastrointestinal disorders; conjunctivitis. Variables on symptomatology will be created by considering each symtom singularly and by combining them using a priori definition (e.g. WHO) and a posteriori approach (based on EPICOVID19 data). Logistic regression models will be applied to assess the measurements of association between exposures of interest and COVID-19-like symptoms by estimating the aOR and 95%CI.
Number of participants (%) with SARS-CoV-2 nasopharyngeal swab (NPS) test positivity
时间窗: 3 months (July 2020) after initial data collection (April 2020)
Measured by using answers collected thorugh the on-line questionnaire about molecular NPS tests results. Logistic regression models will be applied to assess the measurements of association between exposures of interest and SARS-CoV-2 NPS positivity versus negativity by estimating the odds ratios (aOR) and 95% Confidence Intervals (CI).
次要结局
未报告次要终点