Covid19 Clinical Trial
— EPICOVID19Official title:
Italian Web-based EPICOVID19 Cross-sectional Survey
Verified date | September 2021 |
Source | Institute of Biomedical Technologies-National Research Council, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200000 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age of >=18 years; - access to a mobile phone, computer, or tablet with internet connectivity; - on-line consent to participate in the study. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Biomedical Technologies-National Research Council | Segrate | MI |
Lead Sponsor | Collaborator |
---|---|
Institute of Biomedical Technologies-National Research Council, Italy | Institute of Neuroscience-National Research Council, Italian Society for Infectious and Tropical Diseases, Italian Society of Gerontology and Geriatrics, National Research Council, Institute of Clinical Physiology, Italy, University of Milan |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants (%) with COVID-19-like symptoms | 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. |
3 months (July 2020) after initial data collection (April 2020) | |
Primary | Number of participants (%) with SARS-CoV-2 nasopharyngeal swab (NPS) test positivity | 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). |
3 months (July 2020) after initial data collection (April 2020) |
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