Covid19ComCorNCT04607941
Study of Socio-demographic Factors, Behaviors and Practices Associated With Infection With SARS-CoV-2 Responsible for COVID-19
An observational study of Covid19, run by Institut Pasteur at 2 sites in France.
Trial summary
The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Questionnaires and Phone interviews
- How many people
- 766,818 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Oct 2020to 30 Sep 2022
- 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: Index cases: People with positive SARS-CoV-2 test identified by the National Health Insurance (CNAM) in the nationwide database SIDEP (COVID-19 diagnosis information system), which is a system that collects data from tests performed in all testing facilities in France. Only people who have given their e-mail address to the CNAM will be contacted. Close subjects: Invited by index cases with whom they live. "Distant" controls: Selected by Ipsos' panel on age, gender and location of residence criteria (to allow for matched case-control analysis) and Health Care Workers.
Who may be able to join
- All participants:
- Aged 18 years or more
- Agreeing to participate in the study
- Index cases:
- Cases identified by the National Health Insurance (CNAM) in the nationwide database SIDEP (COVID-19 diagnosis information system)
- Positive SARS-CoV-2 RT-PCR on nasopharyngeal or throat swab (or another sample which state of the art considers that it indicates an active infection if positive)
Show all 14Show fewer
- "Distant" controls:
- Selected by Ipsos among Ipsos' panel on age, gender and location of residence criteria (to allow for matched case-control analysis)
- Health Care Workers
- Close subjects:
- People who live in the same household as a case and who have been invited to participate by that case
- People who have had a RT-PCR test on nasopharyngeal or throat swab (or another sample which state of the art considers it indicates an active infection if positive) following diagnosis of the index case (following contact tracing recommendations), classified as:
- close cases if test is positive
- close controls if test is negative
Who cannot join
- For all participants:
- People under judicial protection measures ("sauvegarde de justice", "curatelle", "curatelle renforcée", "tutelle", ie various forms of curatorship under French law)
- For related cases, related controls and "distant" controls:
- People with a history of SARS-CoV-2 infection confirmed by RT-PCR or positive testing of anti-SARS-CoV-2 antibodies with serology (for related cases: before the current episode)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of Socio-demographic Factors, Behaviors and Practices Associated With Infection With SARS-CoV-2
The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.
It is a case-control study including :
Read more
- cases identified by the nationwide system of positive SARS-CoV-2 tests (COVID-19 diagnosis information system, SIDEP) (currently limited to qRT-PCR) and invited to participate by the National Health Insurance (CNAM) which hosts the data from the nationwide test system;
- controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories), gender and geographic area (departement);
- cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.
Data will be collected via a self-administered online questionnaire. Some of the participants will be called for a complementary telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.
Read the detailed description
The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.
The study will focus on sociodemographic data (age, gender, location of residence, socio-economic level, etc.), behaviors and practices (adherence to hand-washing, mask-wearing, work habits, meetings, etc.), the places they visit (public transportation, bars, restaurants, sport facilities, etc.).
It is a case-control study including :
- cases identified by the nationwide system of positive SARS-CoV-2 tests (SIDEP) (currently limited to RT-PCR) and invited to participate by CNAM, which hosts the data from the nationwide test system, through a nationwide email campaign sent once a week; cases will be asked if they can tell where they most probably were infected, leading to a detailed description of the circumstances of the contamination, including whether the suspected contamination took place within the household or not.
- controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories up to 68 years old included as expected adherence to an online questionnaire quickly drops beyond that age), gender and geographic area (departement); invitations will be sent every week via email to adapt the profile of recruited controls to the age, gender and geographic profiles of the cases that participated in the previous week;
- cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. Cases will be recommended not to invite the person that they suspect was responsible for their contamination, if a intra-household contamination is suspected. They will indicate the email address of that person to allow sending of an invitation via email. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.
Analysis will also include descriptive analysis:
- Estimation of the proportion of cases infected within the household or outside
- Among the cases with a extra-household contamination suspicion, proportion of cases for whom infection circumstances are known and description of these circumstances
- Proportion of cases for whom no specific circumstance of contamination could be evidenced.
Questionnaires will focus on the 10 days preceding :
- symptom onset (symptomatic cases)
- day of testing (asymptomatic cases)
- day of symptom onset of the first case within a household (people from the same household as cases) or testing of the first case if they are asymptomatic
- questionnaire completion (Ipsos-recruited controls)
Participants will be offered at the end of the online self-administered questionnaire to indicate a phone number. Among those agreeing to do so, a random sample of case-control pairs and cases of particular interest (eg with specific contamination circumstances) will be called within two weeks following the online questionnaire for a more detailed telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.
- Conditions
- Covid19
- Being tested
- Questionnaires, Phone interviews
- Keywords
- Covid19, behavior, epidemiology, questionnaires
- Medical subject headings
- COVID-19, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Self-administered questionnaires
Phone interviewsOther
A small amount of subjects will be selected at random for phone interviews.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Subjects diagnosed as positive for SARS-CoV-2 infection Receives: Other: Questionnaires; Other: Phone interviews | |
| Close Subjects | Subjects living within the same household as cases:
* close cases if tested positive for SARS-CoV-2 following contact tracing recommendations
* close controls if tested negative for SARS-CoV-2 following contact tracing recommendations Receives: Other: Questionnaires; Other: Phone interviews | |
| Control Subjects | Controls selected within the population to allow for an age, gender and location of residence-matched analysis with cases Receives: Other: Questionnaires; Other: Phone interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the online questionnaire
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places through case-control analyses.
Measured: 1 year
Secondary outcomes (9)
Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the phone interview
Proportion of cases reporting likely contamination circumstances in the family environment
Measured: 1 year
Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the online questionnaire
Proportion of cases reporting likely contamination circumstances in the family environment
Measured: 1 year
Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the phone interview
Proportion of cases reporting likely contamination circumstances in the professional environment
Measured: 1 year
Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the online questionnaire
Proportion of cases reporting likely contamination circumstances in the professional environment
Measured: 1 year
Level of adherence to mask-wearing reported in the phone interview
Proportion of participants reporting adherence to mask-wearing
Measured: 1 year
Level of adherence to mask-wearing reported in the online questionnaire
Proportion of participants reporting adherence to mask-wearing
Measured: 1 year
Level of adherence to hand-washing in the phone interview
Proportion of participants reporting adherence to hand-washing
Measured: 1 year
Level of adherence to hand-washing in the online questionnaire
Proportion of participants reporting adherence to hand-washing
Measured: 1 year
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the phone interview
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places through case-control analyses.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start27 Oct 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 766,818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Health Insurance Fund, IPSOS, Institut de Recherche en Santé Publique, France, Université de Nantes, Assistance Publique - Hôpitaux de Paris, iPLesp
- Responsible party
- Sponsor
- Investigators
- Arnaud Fontanet, Pr, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607941
- Sponsor's protocol ID
- 2020-047
- Other IDs
- 2020-A02560-39
- Acronym
- ComCor
- Status last verified
- Apr 2022
- First submitted
- 20 Oct 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lievre G, Sicsic J, Galmiche S, Charmet T, Fontanet A, Mueller J. Are psychological attitudes towards vaccination an expression of personality? A cross-sectional study on COVID-19 vaccination in France. BMC Public Health. 2025 Jan 17;25(1):209. doi: 10.1186/s12889-025-21364-9.
PubMed 39825254Galmiche S, Charmet T, Rakover A, Cheny O, Omar F, David C, Mailles A, Carrat F, Fontanet A. Risk of SARS-CoV-2 infection in professional settings, shops, shared transport, and leisure activities in France, 2020-2022. BMC Public Health. 2024 Sep 4;24(1):2411. doi: 10.1186/s12889-024-19651-y.
PubMed 39232732Lievre G, Sicsic J, Galmiche S, Charmet T, Fontanet A, Mueller JE. Are the 7C psychological antecedents associated with COVID-19 vaccine behaviours beyond intentions? A cross-sectional study on at-least-one-dose and up-to-date vaccination status, and uptake speed among adults in France. Vaccine. 2024 May 22;42(14):3288-3299. doi: 10.1016/j.vaccine.2024.04.024. Epub 2024 Apr 19.
PubMed 38643038Rakover A, Galmiche S, Charmet T, Cheny O, Omar F, David C, Martin S, Mailles A, Fontanet A. Source of SARS-CoV-2 infection: results from a series of 584,846 cases in France from October 2020 to August 2022. BMC Public Health. 2024 Jan 30;24(1):325. doi: 10.1186/s12889-024-17772-y.
PubMed 38287286Galmiche S, Charmet T, Rakover A, Schaeffer L, Cheny O, von Platen C, Omar F, David C, Mailles A, Carrat F, Fontanet A. Risk of SARS-CoV-2 Infection Among Households With Children in France, 2020-2022. JAMA Netw Open. 2023 Sep 5;6(9):e2334084. doi: 10.1001/jamanetworkopen.2023.34084.
PubMed 37713194Galmiche S, Charmet T, Madec Y, Rakover A, Schaeffer L, Cheny O, Omar F, Martin S, Mailles A, Carrat F, Fontanet A. Reduction of SARS-CoV-2 intra-household child-to-parent transmission associated with ventilation: results from a case-control study. BMC Public Health. 2023 Jun 26;23(1):1240. doi: 10.1186/s12889-023-16144-2.
PubMed 37365557
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Socio-demographic Factors, Behaviors and Practices Associated With Infection With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04607941
- Acronym / sponsor ID
- ComCor / 2020-047
- Conditions
- Covid19
- Keywords
- Covid19, behavior, epidemiology, questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 766,818 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- National Health Insurance Fund, IPSOS, Institut de Recherche en Santé Publique, France, Université de Nantes, Assistance Publique - Hôpitaux de Paris, iPLesp
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 29 Oct 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 objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.
It is a case-control study including :
- cases identified by the nationwide system of positive SARS-CoV-2 tests (COVID-19 diagnosis information system, SIDEP) (currently limited to qRT-PCR) and invited to participate by the National Health Insurance (CNAM) which hosts the data from the nationwide test system;
- controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories), gender and geographic area (departement);
- cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.
Data will be collected via a self-administered online questionnaire. Some of the participants will be called for a complementary telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.
Detailed description
The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.
The study will focus on sociodemographic data (age, gender, location of residence, socio-economic level, etc.), behaviors and practices (adherence to hand-washing, mask-wearing, work habits, meetings, etc.), the places they visit (public transportation, bars, restaurants, sport facilities, etc.).
It is a case-control study including :
- cases identified by the nationwide system of positive SARS-CoV-2 tests (SIDEP) (currently limited to RT-PCR) and invited to participate by CNAM, which hosts the data from the nationwide test system, through a nationwide email campaign sent once a week; cases will be asked if they can tell where they most probably were infected, leading to a detailed description of the circumstances of the contamination, including whether the suspected contamination took place within the household or not.
- controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories up to 68 years old included as expected adherence to an online questionnaire quickly drops beyond that age), gender and geographic area (departement); invitations will be sent every week via email to adapt the profile of recruited controls to the age, gender and geographic profiles of the cases that participated in the previous week;
- cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. Cases will be recommended not to invite the person that they suspect was responsible for their contamination, if a intra-household contamination is suspected. They will indicate the email address of that person to allow sending of an invitation via email. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.
Analysis will also include descriptive analysis:
- Estimation of the proportion of cases infected within the household or outside
- Among the cases with a extra-household contamination suspicion, proportion of cases for whom infection circumstances are known and description of these circumstances
- Proportion of cases for whom no specific circumstance of contamination could be evidenced.
Questionnaires will focus on the 10 days preceding :
- symptom onset (symptomatic cases)
- day of testing (asymptomatic cases)
- day of symptom onset of the first case within a household (people from the same household as cases) or testing of the first case if they are asymptomatic
- questionnaire completion (Ipsos-recruited controls)
Participants will be offered at the end of the online self-administered questionnaire to indicate a phone number. Among those agreeing to do so, a random sample of case-control pairs and cases of particular interest (eg with specific contamination circumstances) will be called within two weeks following the online questionnaire for a more detailed telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Questionnaires, Other: Phone interviewsSubjects diagnosed as positive for SARS-CoV-2 infection |
| Close Subjects | – | Other: Questionnaires, Other: Phone interviewsSubjects living within the same household as cases: * close cases if tested positive for SARS-CoV-2 following contact tracing recommendations * close controls if tested negative for SARS-CoV-2 following contact tracing recommendations |
| Control Subjects | – | Other: Questionnaires, Other: Phone interviewsControls selected within the population to allow for an age, gender and location of residence-matched analysis with cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Index cases: People with positive SARS-CoV-2 test identified by the National Health Insurance (CNAM) in the nationwide database SIDEP (COVID-19 diagnosis information system), which is a system that collects data from tests performed in all testing facilities in France. Only people who have given their e-mail address to the CNAM will be contacted. Close subjects: Invited by index cases with whom they live. "Distant" controls: Selected by Ipsos' panel on age, gender and location of residence criteria (to allow for matched case-control analysis) and Health Care Workers.
Key inclusion criteria (14 listed)
- Aged 18 years or more
- Agreeing to participate in the study
- Cases identified by the National Health Insurance (CNAM) in the nationwide database SIDEP (COVID-19 diagnosis information system)
- Positive SARS-CoV-2 RT-PCR on nasopharyngeal or throat swab (or another sample which state of the art considers that it indicates an active infection if positive)
- Selected by Ipsos among Ipsos' panel on age, gender and location of residence criteria (to allow for matched case-control analysis)
Key exclusion criteria (4 listed)
- People under judicial protection measures ("sauvegarde de justice", "curatelle", "curatelle renforcée", "tutelle", ie various forms of curatorship under French law)
- People with a history of SARS-CoV-2 infection confirmed by RT-PCR or positive testing of anti-SARS-CoV-2 antibodies with serology (for related cases: before the current episode)
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 |
|---|---|---|
| QuestionnairesSelf-administered questionnaires | Other | Cases, Close Subjects, Control Subjects |
| Phone interviewsA small amount of subjects will be selected at random for phone interviews. | Other | Cases, Close Subjects, Control Subjects |
Primary outcome
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the online questionnaire
Time frame: 1 year
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places through case-control analyses.
9 secondary outcomes
Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the phone interview
Time frame: 1 year
Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the online questionnaire
Time frame: 1 year
Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the phone interview
Time frame: 1 year
Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the online questionnaire
Time frame: 1 year
Level of adherence to mask-wearing reported in the phone interview
Time frame: 1 year
Level of adherence to mask-wearing reported in the online questionnaire
Time frame: 1 year
Level of adherence to hand-washing in the phone interview
Time frame: 1 year
Level of adherence to hand-washing in the online questionnaire
Time frame: 1 year
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the phone interview
Time frame: 1 year
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 6 Apr 2023.
- Derived from this study: PubMed 39825254Lievre G, Sicsic J, Galmiche S, Charmet T, Fontanet A, Mueller J. Are psychological attitudes towards vaccination an expression of personality? A cross-sectional study on COVID-19 vaccination in France. BMC Public Health. 2025 Jan 17;25(1):209. doi: 10.1186/s12889-025-21364-9.
- Derived from this study: PubMed 39232732Galmiche S, Charmet T, Rakover A, Cheny O, Omar F, David C, Mailles A, Carrat F, Fontanet A. Risk of SARS-CoV-2 infection in professional settings, shops, shared transport, and leisure activities in France, 2020-2022. BMC Public Health. 2024 Sep 4;24(1):2411. doi: 10.1186/s12889-024-19651-y.
- Derived from this study: PubMed 38643038Lievre G, Sicsic J, Galmiche S, Charmet T, Fontanet A, Mueller JE. Are the 7C psychological antecedents associated with COVID-19 vaccine behaviours beyond intentions? A cross-sectional study on at-least-one-dose and up-to-date vaccination status, and uptake speed among adults in France. Vaccine. 2024 May 22;42(14):3288-3299. doi: 10.1016/j.vaccine.2024.04.024. Epub 2024 Apr 19.
- Derived from this study: PubMed 38287286Rakover A, Galmiche S, Charmet T, Cheny O, Omar F, David C, Martin S, Mailles A, Fontanet A. Source of SARS-CoV-2 infection: results from a series of 584,846 cases in France from October 2020 to August 2022. BMC Public Health. 2024 Jan 30;24(1):325. doi: 10.1186/s12889-024-17772-y.
- Derived from this study: PubMed 37713194Galmiche S, Charmet T, Rakover A, Schaeffer L, Cheny O, von Platen C, Omar F, David C, Mailles A, Carrat F, Fontanet A. Risk of SARS-CoV-2 Infection Among Households With Children in France, 2020-2022. JAMA Netw Open. 2023 Sep 5;6(9):e2334084. doi: 10.1001/jamanetworkopen.2023.34084.
- Derived from this study: PubMed 37365557Galmiche S, Charmet T, Madec Y, Rakover A, Schaeffer L, Cheny O, Omar F, Martin S, Mailles A, Carrat F, Fontanet A. Reduction of SARS-CoV-2 intra-household child-to-parent transmission associated with ventilation: results from a case-control study. BMC Public Health. 2023 Jun 26;23(1):1240. doi: 10.1186/s12889-023-16144-2.
- 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.
Arnaud Fontanet, Pr principal investigator
Institut Pasteur
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Institut Pasteur at 2 sites in France.
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 14 inclusion and 4 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the online questionnaire (time frame: 1 year). 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 NCT04607941, which also lists 6 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 6 Apr 2023.