Italian Web-based Cross-sectional Survey on COVID-19

NCT04471701 | Completed

• 1 other identifier: EPICOVID19_2020
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV Infection; Survey, Family Life; Epidemic Disease; Self-Assessment

Keywords

SARS-CoV-2;COVID-19;voluntary respondents;web-based survey

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Interventions

Environmental exposure and clinical features BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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/).

You may qualify if:

• age of \>=18 years;
• access to a mobile phone, computer, or tablet with internet connectivity;
• on-line consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Biomedical Technologies-National Research Council, Italy: lead
• National Research Council, Institute of Clinical Physiology, Italy: collaborator
• Institute of Neuroscience-National Research Council: collaborator
• University of Milan: collaborator
• Italian Society of Gerontology and Geriatrics: collaborator
• Italian Society for Infectious and Tropical Diseases: collaborator

Study Sites (1)

Institute of Biomedical Technologies-National Research Council

Segrate, MI, 20090, Italy

Location

Related Publications (4)

• Prinelli F, Trevisan C, Noale M, Franchini M, Giacomelli A, Cori L, Jesuthasan N, Incalzi RA, Maggi S, Adorni F; EPICOVID19 Working Group. Sex- and gender-related differences linked to SARS-CoV-2 infection among the participants in the web-based EPICOVID19 survey: the hormonal hypothesis. Maturitas. 2022 Apr;158:61-69. doi: 10.1016/j.maturitas.2021.11.015. Epub 2021 Dec 4.

  PMID: 35241240 DERIVED

• Prinelli F, Bianchi F, Drago G, Ruggieri S, Sojic A, Jesuthasan N, Molinaro S, Bastiani L, Maggi S, Noale M, Galli M, Giacomelli A, Antonelli Incalzi R, Adorni F, Cibella F; EPICOVID19 Working Group. Association Between Smoking and SARS-CoV-2 Infection: Cross-sectional Study of the EPICOVID19 Internet-Based Survey. JMIR Public Health Surveill. 2021 Apr 28;7(4):e27091. doi: 10.2196/27091.

  PMID: 33668011 DERIVED

• Trevisan C, Noale M, Prinelli F, Maggi S, Sojic A, Di Bari M, Molinaro S, Bastiani L, Giacomelli A, Galli M, Adorni F, Antonelli Incalzi R, Pedone C; EPICOVID19 Working Group. Age-Related Changes in Clinical Presentation of Covid-19: the EPICOVID19 Web-Based Survey. Eur J Intern Med. 2021 Apr;86:41-47. doi: 10.1016/j.ejim.2021.01.028. Epub 2021 Jan 29.

  PMID: 33579579 DERIVED

• Adorni F, Prinelli F, Bianchi F, Giacomelli A, Pagani G, Bernacchia D, Rusconi S, Maggi S, Trevisan C, Noale M, Molinaro S, Bastiani L, Fortunato L, Jesuthasan N, Sojic A, Pettenati C, Tavio M, Andreoni M, Mastroianni C, Antonelli Incalzi R, Galli M. Self-Reported Symptoms of SARS-CoV-2 Infection in a Nonhospitalized Population in Italy: Cross-Sectional Study of the EPICOVID19 Web-Based Survey. JMIR Public Health Surveill. 2020 Sep 18;6(3):e21866. doi: 10.2196/21866.

  PMID: 32650305 DERIVED

Related Links

• Institutional web-site of ITB-CNR
• Rapid COVID-19 Screening Based on Self-Reported Symptoms: Psychometric Assessment and Validation of the EPICOVID19 Short Diagnostic Scale
• Self-Reported Symptoms of SARS-CoV-2 Infection in a Nonhospitalized Population in Italy: Cross-Sectional Study of the EPICOVID19 Web-Based Survey

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Environmental Exposure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Environmental Pollution; Public Health; Environment and Public Health

Study Officials

• Federica Prinelli, PhD

  Institute of Biomedical Technologies-National Research Council

  PRINCIPAL INVESTIGATOR

• Fulvio Adorni, MPH

  Institute of Biomedical Technologies-National Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 15, 2020
• Study Start: April 13, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: April 7, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)