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Italian Web-based Cross-sectional Survey on COVID-19 (EPICOVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04471701
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : July 16, 2020
Sponsor:
Collaborators:
National Research Council, Institute of Clinical Physiology, Italy
Institute of Neuroscience-National Research Council
University of Milan
Italian Society of Geriatrics and Gerontology
Italian Society of Infectious and Tropical Diseases
Information provided by (Responsible Party):
Institute of Biomedical Technologies-National Research Council, Italy

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Italian Web-based EPICOVID19 Cross-sectional Survey
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.


  2. 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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
EPICOVID19 is a national Italian internet-based survey that targets adult volunteers (males and females >=18 years old) living in Italy during the lockdown (started in Italy on 9 March 2020). In order to enrol as many subjects as possible, the survey was promoted using social media (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/).
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Federica Prinelli, PhD +39 0226422629 federica.prinelli@itb.cnr.it
Contact: Fulvio Adorni, MPH +39 0226422629 fulvio.adorni@itb.cnr.it

Locations
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Italy
Institute of Biomedical Technologies-National Research Council Recruiting
Segrate, MI, Italy, 20090
Contact: Federica Prinelli, PhD    +39 0226422629    federica.prinelli@itb.cnr.it   
Contact: Fulvio Adorni, MPH    +39 0226422629    fulvio.adorni@itb.cnr.it   
Sponsors and Collaborators
Institute of Biomedical Technologies-National Research Council, Italy
National Research Council, Institute of Clinical Physiology, Italy
Institute of Neuroscience-National Research Council
University of Milan
Italian Society of Geriatrics and Gerontology
Italian Society of Infectious and Tropical Diseases
Investigators
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Principal Investigator: Federica Prinelli, PhD Institute of Biomedical Technologies-National Research Council
Principal Investigator: Fulvio Adorni, MPH Institute of Biomedical Technologies-National Research Council
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institute of Biomedical Technologies-National Research Council, Italy
ClinicalTrials.gov Identifier: NCT04471701    
Other Study ID Numbers: EPICOVID19_2020
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Biomedical Technologies-National Research Council, Italy:
SARS-CoV-2;COVID-19;voluntary respondents;web-based survey
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases