Covid19EPICOVID19NCT04471701
Italian Web-based Cross-sectional Survey on COVID-19
An observational study of Covid19 and SARS-CoV Infection, run by Institute of Biomedical Technologies-National Research Council, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection, Survey, Family Life
- What is being tested?
- Environmental exposure and clinical features
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 200,000 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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/).
Who may be able to join
- age of >=18 years;
- access to a mobile phone, computer, or tablet with internet connectivity;
- on-line consent to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedical Technologies-National Research Council
Segrate, MI, 20090
About this study
Official title: Italian Web-based EPICOVID19 Cross-sectional Survey
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Environmental exposure and clinical features
- Keywords
- SARS-CoV-2;COVID-19;voluntary respondents;web-based survey
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental exposure and clinical featuresBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 months (July 2020) after initial data collection (April 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start13 Apr 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biomedical Technologies-National Research Council, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Institute of Clinical Physiology, Italy, Institute of Neuroscience-National Research Council, University of Milan, Italian Society of Gerontology and Geriatrics, Italian Society for Infectious and Tropical Diseases
- Responsible party
- Sponsor
- Investigators
- Federica Prinelli, PhD, Principal investigator, Institute of Biomedical Technologies-National Research CouncilFulvio Adorni, MPH, Principal investigator, Institute of Biomedical Technologies-National Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471701
- Sponsor's protocol ID
- EPICOVID19_2020
- Acronym
- EPICOVID19
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35241240Prinelli 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.
PubMed 33668011Trevisan 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.
PubMed 33579579Adorni 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.
PubMed 32650305
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Web-based EPICOVID19 Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT04471701
- Acronym / sponsor ID
- EPICOVID19 / EPICOVID19_2020
- Keywords
- SARS-CoV-2;COVID-19;voluntary respondents;web-based survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200,000 participants (actual)
- Lead sponsor
- Institute of Biomedical Technologies-National Research Council, ItalyUniversity, hospital or other
- Collaborators
- National Research Council, Institute of Clinical Physiology, Italy, Institute of Neuroscience-National Research Council, University of Milan, Italian Society of Gerontology and Geriatrics, Italian Society for Infectious and Tropical Diseases
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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/).
Key inclusion criteria (3 listed)
- age of >=18 years;
- access to a mobile phone, computer, or tablet with internet connectivity;
- on-line consent to participate in the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental exposure and clinical featuresEnvironmental 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. | Behavioural | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 35241240Prinelli 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.
- Derived from this study: PubMed 33668011Prinelli 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.
- Derived from this study: PubMed 33579579Trevisan 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.
- Derived from this study: PubMed 32650305Adorni 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.
- Rapid COVID-19 Screening Based on Self-Reported Symptoms: Psychometric Assessment and Validation of the EPICOVID19 Short Diagnostic ScaleLink provided by the sponsor.
- Self-Reported Symptoms of SARS-CoV-2 Infection in a Nonhospitalized Population in Italy: Cross-Sectional Study of the EPICOVID19 Web-Based SurveyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federica Prinelli, PhD principal investigator
Institute of Biomedical Technologies-National Research Council
Fulvio Adorni, MPH principal investigator
Institute of Biomedical Technologies-National Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV Infection, run by Institute of Biomedical Technologies-National Research Council, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants (%) with COVID-19-like symptoms (time frame: 3 months (July 2020) after initial data collection (April 2020)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471701, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.