<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04471701</url>
  </required_header>
  <id_info>
    <org_study_id>EPICOVID19_2020</org_study_id>
    <nct_id>NCT04471701</nct_id>
  </id_info>
  <brief_title>Italian Web-based Cross-sectional Survey on COVID-19</brief_title>
  <acronym>EPICOVID19</acronym>
  <official_title>Italian Web-based EPICOVID19 Cross-sectional Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Biomedical Technologies-National Research Council, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Council, Institute of Clinical Physiology, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Neuroscience-National Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Italian Society of Gerontology and Geriatrics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Italian Society for Infectious and Tropical Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Biomedical Technologies-National Research Council, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that started in&#xD;
      late December 2019 in the Hubei province of China caused millions of cases worldwide in just&#xD;
      a few months, and evolved into a real pandemic.&#xD;
&#xD;
      However, only approximately 20% of SARS-CoV-2 infected patients required intensive on&#xD;
      sub-intensice medical care and the remained experience mild or subclinical form of the&#xD;
      disease that did not require hospital admission and a relatively high percentage (40 to 45%)&#xD;
      remained asymptomatic.&#xD;
&#xD;
      Understanding the occurrence of SARS-CoV-2-like infectious in a large non-hospitalized&#xD;
      population, when the epidemic peak was occurring in Italy, is of paramount importance but&#xD;
      data are scarce.&#xD;
&#xD;
      The goal of this research project is to estimate the number of suspected cases of COVID-19&#xD;
      and to investigate the role of the potential factors associated with SARS-CoV-2 infection in&#xD;
      a large Italian sample of respondents living in Italy during the lockdown (started in Italy&#xD;
      on 9 March 2020).&#xD;
&#xD;
      EPICOVID19 is an Italian countrywide self-administered cross-sectional web-based survey on&#xD;
      adult volunteers launched on April 13, 2020.&#xD;
&#xD;
      The on-line questionnaire has been developed starting from the available literature and&#xD;
      implemented using an open source platform focusing on beahvioural and clinical features of&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The COVID-19 pandemic is posing an unprecedented threat worldwide, which have been&#xD;
      experiencing widespread transmission of the virus in the community for several weeks.&#xD;
&#xD;
      During the epidemic peak, epidemiological surveillance strategies were mainly based on the&#xD;
      testing of symptomatic patients with serious diseases requiring hospitalization and intensive&#xD;
      or sub-intensive medical care. This has underestimated the real spread of the infection in&#xD;
      the mild symptomatic (paucisymptomatic) or asymptomatic individuals or in specific group of&#xD;
      persons with limited access to testing.&#xD;
&#xD;
      EPICOVID19 was developed and launched to accomplish the following objectives: i) to estimate&#xD;
      the number of suspected cases of COVID-19 in the general population, and ii) to investigate&#xD;
      the role of the potential factors associated with SARS-CoV-2 infection in adult volunteers&#xD;
      living in Italy during the lockdown.&#xD;
&#xD;
      EPICOVID19 is a national Italian anonymous self-administered internet-based survey that was&#xD;
      carried out using a cross-sectional research design in a convenience sample of adult&#xD;
      volunteers (18+ years old) living in Italy during the lockdown. The survey was launched on 13&#xD;
      April 2020.&#xD;
&#xD;
      In order to enrol as many subjects as possible, the link to the electronic survey was&#xD;
      uploaded, shared and disseminated via several channels: e-mails, social media platforms&#xD;
      (Facebook, Twitter, Instagram, Whatsapp), press releases, internet pages, local radio and TV&#xD;
      stations, and institutional websites that called upon volunteers to contact the study website&#xD;
      https://epicovid19.itb.cnr.it/.&#xD;
&#xD;
      The EPICOVID19 study was established as a collaboration of a working work including&#xD;
      epidemiologists, clinicians, biostatisticians, and public health professionals to improve&#xD;
      SARS-CoV-2-related knowledge. The steering group tested the survey for a period of 2 weeks&#xD;
      before starting to share the public link to the general population on April 13, 2020. The&#xD;
      participants are asked to complete the self-administered 38-item questionnaire, which&#xD;
      contained mainly mandatory and closed questions that is divided into six sections.&#xD;
&#xD;
      EPICOVID19 was designed by the steering group after a literature review of existing research&#xD;
      into COVID-19. To guarantee the maximal comparability to other large epidemiological studies,&#xD;
      several questions was chosen based on standardized and validated questionnaires. The survey&#xD;
      was adapted to the national context and implemented using the European Commission's&#xD;
      open-source official EUSurvey management tool (https://ec.europa.eu/eusurvey).&#xD;
&#xD;
      The survey includes an introductory page briefly describing the rational and the aims of the&#xD;
      study, the consortium, and the option to provide or not the consent to participate.&#xD;
&#xD;
      The first section of the questionnaire investigates the socio-demographic characteristics of&#xD;
      the respondents: sex at birth, birth year, ethnicity, user's postal code and municipality of&#xD;
      residence, educational level, employment status, and current (or last) occupation.&#xD;
&#xD;
      The second section of the questionnaire investigates the clinical features: SARS-CoV-2&#xD;
      infection-like symptoms and the month of onset of the first symptoms, pre-existing diseases,&#xD;
      other conditions to refer, vaccines, past and current use of medication and supplements, and,&#xD;
      for females only, use of contraception or hormone replacement therapy at menopause, and&#xD;
      number of completed pregnancies, when applicable. Data about close contact with confirmed or&#xD;
      suspected cases, contacts with general practitioner and/or national emergency numbers,&#xD;
      molecular tests and results (if available), hospitalization for confirmed or suspected&#xD;
      SARS-CoV-2-like infection, and other possible risk conditions to refer, are also collected.&#xD;
&#xD;
      The third section of the questionnaire is focused on the personal characteristics and health&#xD;
      status of respondents: questions about self-perceived health status and risk perception .&#xD;
&#xD;
      The fourth section investigates the housing conditions: population density in the area of&#xD;
      residence, self-reported traffic intensity in the area of residence, number of rooms, number&#xD;
      of co-habitants, and presence of at-risk co-habitants.&#xD;
&#xD;
      The fifth section focuses on lifestyles: daily mean number of contacts, smoking habit, and&#xD;
      frequency of weekly physical activity.&#xD;
&#xD;
      The sixth section investigates the behaviours following the lockdown: job conditions, number&#xD;
      of times of going out per week, and use of public transportation.&#xD;
&#xD;
      The Ethics Committee of the Istituto Nazionale per le Malattie Infettive I.R.C.C.S. Lazzaro&#xD;
      Spallanzani (Protocol No. 70, 12/4/2020) approved the EPICOVID19 study protocol. When they&#xD;
      first accessed the on-line platform, the participants were informed of the purpose of the&#xD;
      study, the data to be collected, and the method of storage. The data were handled and stored&#xD;
      in accordance with the European Union General Data Protection Regulation (EU GDPR) 2016/679&#xD;
      (http://gdpr-info.eu/), and data transfer was safeguarded by means of encrypting/decrypting&#xD;
      and password protection. The study was conducted according to the Declaration of Helsinki.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants (%) with COVID-19-like symptoms</measure>
    <time_frame>3 months (July 2020) after initial data collection (April 2020)</time_frame>
    <description>Measured by using answers on the Clinical evaluation section of the questionnaire: Fever &gt; 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.&#xD;
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).&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants (%) with SARS-CoV-2 nasopharyngeal swab (NPS) test positivity</measure>
    <time_frame>3 months (July 2020) after initial data collection (April 2020)</time_frame>
    <description>Measured by using answers collected thorugh the on-line questionnaire about molecular NPS tests results.&#xD;
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).</description>
  </primary_outcome>
  <enrollment type="Actual">200000</enrollment>
  <condition>Covid19</condition>
  <condition>SARS-CoV Infection</condition>
  <condition>Survey, Family Life</condition>
  <condition>Epidemic Disease</condition>
  <condition>Self-Assessment</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Environmental exposure and clinical features</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        EPICOVID19 is a national Italian internet-based survey that targets adult volunteers (males&#xD;
        and females &gt;=18 years old) living in Italy during the lockdown (started in Italy on 9&#xD;
        March 2020). In order to enrol as many subjects as possible, the survey was promoted using&#xD;
        social media (Facebook, Twitter, Instagram, Whatsapp), press releases, internet pages,&#xD;
        local radio and TV stations, and institutional websites that called upon volunteers to&#xD;
        contact the study website (https://epicovid19.itb.cnr.it/).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of &gt;=18 years;&#xD;
&#xD;
          -  access to a mobile phone, computer, or tablet with internet connectivity;&#xD;
&#xD;
          -  on-line consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age of &lt;18 years;&#xD;
&#xD;
          -  without access to a mobile phone, computer, or tablet with internet connectivity;&#xD;
&#xD;
          -  not provide on-line consent to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federica Prinelli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Biomedical Technologies-National Research Council</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fulvio Adorni, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Biomedical Technologies-National Research Council</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Biomedical Technologies-National Research Council</name>
      <address>
        <city>Segrate</city>
        <state>MI</state>
        <zip>20090</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://epicovid19.itb.cnr.it/</url>
    <description>Institutional web-site of ITB-CNR</description>
  </link>
  <link>
    <url>https://www.mdpi.com/2076-393X/8/4/669</url>
    <description>Missed Opportunities of Flu Vaccination in Italian Target Categories: Insights from the Online EPICOVID 19 Survey</description>
  </link>
  <link>
    <url>https://www.jmir.org/2021/1/e23897/</url>
    <description>Rapid COVID-19 Screening Based on Self-Reported Symptoms: Psychometric Assessment and Validation of the EPICOVID19 Short Diagnostic Scale</description>
  </link>
  <link>
    <url>https://www.mdpi.com/2076-393X/8/3/471</url>
    <description>The Association between Influenza and Pneumococcal Vaccinations and SARS-Cov-2 Infection: Data from the EPICOVID19 Web-Based Survey</description>
  </link>
  <link>
    <url>https://publichealth.jmir.org/2020/3/e21866/</url>
    <description>Self-Reported Symptoms of SARS-CoV-2 Infection in a Nonhospitalized Population in Italy: Cross-Sectional Study of the EPICOVID19 Web-Based Survey</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2;COVID-19;voluntary respondents;web-based survey</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04471701
org study id: EPICOVID19_2020
nct id: NCT04471701
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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/.

      The EPICOVID19 study was established as a collaboration of a working work including
      epidemiologists, clinicians, biostatisticians, and public health professionals to improve
      SARS-CoV-2-related knowledge. The steering group tested the survey for a period of 2 weeks
      before starting to share the public link to the general population on April 13, 2020. The
      participants are asked to complete the self-administered 38-item questionnaire, which
      contained mainly mandatory and closed questions that is divided into six sections.

      EPICOVID19 was designed by the steering group after a literature review of existing research
      into COVID-19. To guarantee the maximal comparability to other large epidemiological studies,
      several questions was chosen based on standardized and validated questionnaires. The survey
      was adapted to the national context and implemented using the European Commission's
      open-source official EUSurvey management tool (https://ec.europa.eu/eusurvey).

      The survey includes an introductory page briefly describing the rational and the aims of the
      study, the consortium, and the option to provide or not the consent to participate.

      The first section of the questionnaire investigates the socio-demographic characteristics of
      the respondents: sex at birth, birth year, ethnicity, user's postal code and municipality of
      residence, educational level, employment status, and current (or last) occupation.

      The second section of the questionnaire investigates the clinical features: SARS-CoV-2
      infection-like symptoms and the month of onset of the first symptoms, pre-existing diseases,
      other conditions to refer, vaccines, past and current use of medication and supplements, and,
      for females only, use of contraception or hormone replacement therapy at menopause, and
      number of completed pregnancies, when applicable. Data about close contact with confirmed or
      suspected cases, contacts with general practitioner and/or national emergency numbers,
      molecular tests and results (if available), hospitalization for confirmed or suspected
      SARS-CoV-2-like infection, and other possible risk conditions to refer, are also collected.

      The third section of the questionnaire is focused on the personal characteristics and health
      status of respondents: questions about self-perceived health status and risk perception .

      The fourth section investigates the housing conditions: population density in the area of
      residence, self-reported traffic intensity in the area of residence, number of rooms, number
      of co-habitants, and presence of at-risk co-habitants.

      The fifth section focuses on lifestyles: daily mean number of contacts, smoking habit, and
      frequency of weekly physical activity.

      The sixth section investigates the behaviours following the lockdown: job conditions, number
      of times of going out per week, and use of public transportation.

      The Ethics Committee of the Istituto Nazionale per le Malattie Infettive I.R.C.C.S. Lazzaro
      Spallanzani (Protocol No. 70, 12/4/2020) approved the EPICOVID19 study protocol. When they
      first accessed the on-line platform, the participants were informed of the purpose of the
      study, the data to be collected, and the method of storage. The data were handled and stored
      in accordance with the European Union General Data Protection Regulation (EU GDPR) 2016/679
      (http://gdpr-info.eu/), and data transfer was safeguarded by means of encrypting/decrypting
      and password protection. The study was conducted according to the Declaration of Helsinki.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of participants (%) with COVID-19-like symptoms
time frame: 3 months (July 2020) after initial data collection (April 2020)
description: 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.
measure: Number of participants (%) with SARS-CoV-2 nasopharyngeal swab (NPS) test positivity
time frame: 3 months (July 2020) after initial data collection (April 2020)
description: 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).
intervention type: Behavioral
intervention name: Environmental exposure and clinical features
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Federica Prinelli, PhD
role: Principal Investigator
affiliation: Institute of Biomedical Technologies-National Research Council
last name: Fulvio Adorni, MPH
role: Principal Investigator
affiliation: Institute of Biomedical Technologies-National Research Council
facility: 
country: Italy
url: http://epicovid19.itb.cnr.it/
description: Institutional web-site of ITB-CNR
url: https://www.mdpi.com/2076-393X/8/4/669
description: Missed Opportunities of Flu Vaccination in Italian Target Categories: Insights from the Online EPICOVID 19 Survey
url: https://www.jmir.org/2021/1/e23897/
description: Rapid COVID-19 Screening Based on Self-Reported Symptoms: Psychometric Assessment and Validation of the EPICOVID19 Short Diagnostic Scale
url: https://www.mdpi.com/2076-393X/8/3/471
description: The Association between Influenza and Pneumococcal Vaccinations and SARS-Cov-2 Infection: Data from the EPICOVID19 Web-Based Survey
url: https://publichealth.jmir.org/2020/3/e21866/
description: Self-Reported Symptoms of SARS-CoV-2 Infection in a Nonhospitalized Population in Italy: Cross-Sectional Study of the EPICOVID19 Web-Based Survey
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
sharing ipd: No