Italian Web-based Cross-sectional Survey on COVID-19 (EPICOVID19)
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|ClinicalTrials.gov Identifier: NCT04471701|
Recruitment Status : Completed
First Posted : July 15, 2020
Last Update Posted : April 7, 2022
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.
|Condition or disease||Intervention/treatment|
|Covid19 SARS-CoV Infection Survey, Family Life Epidemic Disease Self-Assessment||Behavioral: Environmental exposure and clinical features|
|Study Type :||Observational|
|Actual Enrollment :||200000 participants|
|Official Title:||Italian Web-based EPICOVID19 Cross-sectional Survey|
|Actual Study Start Date :||April 13, 2020|
|Actual Primary Completion Date :||February 28, 2021|
|Actual Study Completion Date :||February 28, 2021|
- Behavioral: Environmental exposure and clinical features
Environmental exposures and clinical features are measured by means of a self-administered 38-item on-line questionnaire containing mainly mandatory and closed questions divided into six sections: i) socio-demographic data; ii) clinical evaluation; iii) personal characteristics and health status; iv) housing conditions; v) lifestyle; and vi) behaviours following the lockdown.
- Number of participants (%) with COVID-19-like symptoms [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471701
|Institute of Biomedical Technologies-National Research Council|
|Segrate, MI, Italy, 20090|
|Principal Investigator:||Federica Prinelli, PhD||Institute of Biomedical Technologies-National Research Council|
|Principal Investigator:||Fulvio Adorni, MPH||Institute of Biomedical Technologies-National Research Council|