Covid19SourceCOVIDNCT04670003
Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application
An observational study of Covid19, run by Weprom at 1 site in France.
Trial summary
A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- users
- How many people
- 4,975 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2021to 30 Mar 2021
- How long will I take part?
- 3 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All users of the application contaminated with COVID 19 who have not objected to the use of their data
Who may be able to join
- users of the application
- not having objected to the use of their data
Who cannot join
- user who does not have a complete questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application: an Observational Study
A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases.
Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts…? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.
- Conditions
- Covid19
- Being tested
- users
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usersOther
Data of users of the web-application
| Study group | Role | What they receive |
|---|---|---|
| users | users of web-application Receives: Other: users |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the methods of contamination of patients
Data and symptomes collected by the web applications self-questionnaire (patient reported outcome)
Measured: 2 months
Secondary outcomes (2)
Evaluation in time of the spread of the virus during the 2nd epidemic wave.
Data and symptomes collected by the web applications self-questionnaire (patient reported outcome)
Measured: 2 months
Evaluation in space of the spread of the virus during the 2nd epidemic wave.
Data and symptomes collected by the web applications self-questionnaire according to ZIP code (patient reported outcome)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Jan 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prospective
- Enrolment
- 4,975 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Kelindi
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, MD, Study director, Institut Interrégional de Cancerologie et Kelindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670003
- Sponsor's protocol ID
- WP-2020-05
- Acronym
- SourceCOVID
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Denis F, Septans AL, Le Goff F, Jeanneau S, Lescure FX. Analysis of COVID-19 Transmission Sources in France by Self-Assessment Before and After the Partial Lockdown: Observational Study. J Med Internet Res. 2021 May 4;23(5):e26932. doi: 10.2196/26932.
PubMed 33878018
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application: an Observational Study
- ClinicalTrials.gov ID
- NCT04670003
- Acronym / sponsor ID
- SourceCOVID / WP-2020-05
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,975 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Kelindi
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 17 Dec 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.
A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases.
Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts…? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users | – | Other: usersusers of web-application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All users of the application contaminated with COVID 19 who have not objected to the use of their data
Key inclusion criteria (2 listed)
- users of the application
- not having objected to the use of their data
Key exclusion criteria (1 listed)
- user who does not have a complete questionnaire
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 |
|---|---|---|
| usersData of users of the web-application | Other | users |
Primary outcome
Description of the methods of contamination of patients
Time frame: 2 months
Data and symptomes collected by the web applications self-questionnaire (patient reported outcome)
2 secondary outcomes
Evaluation in time of the spread of the virus during the 2nd epidemic wave.
Time frame: 2 months
Evaluation in space of the spread of the virus during the 2nd epidemic wave.
Time frame: 2 months
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 8 Apr 2021.
- Derived from this study: PubMed 33878018Denis F, Septans AL, Le Goff F, Jeanneau S, Lescure FX. Analysis of COVID-19 Transmission Sources in France by Self-Assessment Before and After the Partial Lockdown: Observational Study. J Med Internet Res. 2021 May 4;23(5):e26932. doi: 10.2196/26932.
- 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.
Fabrice DENIS, MD study director
Institut Interrégional de Cancerologie et Kelindi
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, run by Weprom at 1 site 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 2 inclusion and 1 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 8 Apr 2021. 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 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?
Description of the methods of contamination of patients (time frame: 2 months). 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 NCT04670003, which also lists 1 linked publication.
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 8 Apr 2021.