COVID-19COVID CALL 15NCT04331171
Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage
An observational study of COVID-19, run by Weprom at 1 site in France.
Trial summary
A coronavirus pandemic began on 12/31/2020 with the first Chinese patient. As of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Web application users
- Type of treatment
- Medical device
- How many people
- 12,000,000 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2020to 15 Nov 2020
- How long will I take part?
- 1 Day
- 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: All users of the https://www.maladiecoronavirus.fr/ application over the age of 18
Who may be able to join
- All users of the https://www.maladiecoronavirus.fr/ application over the age of 18
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country.
About this study
A coronavirus pandemic began on 12/31/2020 with the first Chinese patient. As of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. This virus causes a pathology ranging from simple flu symptoms in 80% of cases to acute respiratory distress syndromes requiring resuscitation in 5% of cases and a death rate of 1.4 to 4% of cases.
The arrival in France on 02/25/2020 with an exponential development of the infection (more than 5,000 cases on 03/15/2020) was accompanied by an unprecedented number of calls to the French emergency service call number (15) of worried patients with overload and sometimes saturation of the service that can impact calls and the care of patients really recovering from an emergency.
Read more
We previously developed a Moovcare® web application which showed a 7 months survival benefit by early detection of relapsed lung cancer based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 trial randomized. Another application for detecting and monitoring chemo-induced febrile aplasia appears to show a reduction in the number of hospitalizations for sepsis. Finally, Smokecheck, a self-assessment application for symptoms by smokers, has shown that it improves the detection of symptomatic operable bronchial cancers (9 to 24%, p = 0.04).
The web application https://www.maladiecoronavirus.fr/ was developed with a group of physicians from the Institut Pasteur, Hospitals group of Paris, Hospitals of Lille and Rennes and the ILC Jean Bernard in Le Mans. It makes it possible to guide symptomatic patients and patients who wishing to know what to do (call their general practitioner, teleconsultation, or call emergency service) based on symptoms and predictive factors of severity.
Following the availability of this new tool, we want to assess the impact of the application on the number and relevance of calls to emergency service.
- Conditions
- COVID-19
- Being tested
- Web application users
- Keywords
- M-health, COVID-19, Self-assessment application, epidemiology, symptoms
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web application usersDevice
questionnaire of comorbidity and symptoms completed by the patient on his smartphone
| Study group | Role | What they receive |
|---|---|---|
| Web-application users | questionnaire of comorbidity and symptomes completed by the user on his smartphone Receives: Device: Web application users |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess of the evolution of the number of calls to Emergency service within 12 days after the launch of the application https://www.maladiecoronavirus.fr/
Number of calls to Emergency service after the launch of web application comparded to the days before
Measured: 12 days
To assess of the evolution of the proportion of relevant calls to Emergency service within 12 days after the launch of the application https://www.maladiecoronavirus.fr/
Number of relevants calls to Emergency service after the launch of web application comparded to the days before
Measured: 12 days
Secondary outcomes (4)
To assess the evolution over time of the COVID 19 epidemic
the symptoms collected by the application
Measured: 3 months
To assess the evolution over space of the COVID 19 epidemic
the symptoms collected by the application according to ZIP code
Measured: 3 months
To assess symptoms
Descriptive analysis of symptoms collected by web-application
Measured: 3 months
To assess the users population
Descriptive analysis of data collected by web-application
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start17 Mar 2020
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 12,000,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, Assistance Publique - Hôpitaux de Paris, DOCAPOST, Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, MD, Study director, Jean Bernard Center - LE MANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331171
- Sponsor's protocol ID
- WP-2020-02
- Acronym
- COVID CALL 15
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 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, Fontanet A, Le Douarin YM, Le Goff F, Jeanneau S, Lescure FX. A Self-Assessment Web-Based App to Assess Trends of the COVID-19 Pandemic in France: Observational Study. J Med Internet Res. 2021 Mar 12;23(3):e26182. doi: 10.2196/26182.
PubMed 33709945Galmiche S, Rahbe E, Fontanet A, Dinh A, Benezit F, Lescure FX, Denis F. Implementation of a Self-Triage Web Application for Suspected COVID-19 and Its Impact on Emergency Call Centers: Observational Study. J Med Internet Res. 2020 Nov 23;22(11):e22924. doi: 10.2196/22924.
PubMed 33147165Denis F, Galmiche S, Dinh A, Fontanet A, Scherpereel A, Benezit F, Lescure FX. Epidemiological Observations on the Association Between Anosmia and COVID-19 Infection: Analysis of Data From a Self-Assessment Web Application. J Med Internet Res. 2020 Jun 11;22(6):e19855. doi: 10.2196/19855.
PubMed 32496206
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
- Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage
- ClinicalTrials.gov ID
- NCT04331171
- Acronym / sponsor ID
- COVID CALL 15 / WP-2020-02
- Conditions
- COVID-19
- Keywords
- M-health, COVID-19, Self-assessment application, epidemiology, symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000,000 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Institut Pasteur, Assistance Publique - Hôpitaux de Paris, DOCAPOST, Direction Générale de l'Offre de Soins
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 2 Apr 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 12/31/2020 with the first Chinese patient. As of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. This virus causes a pathology ranging from simple flu symptoms in 80% of cases to acute respiratory distress syndromes requiring resuscitation in 5% of cases and a death rate of 1.4 to 4% of cases.
The arrival in France on 02/25/2020 with an exponential development of the infection (more than 5,000 cases on 03/15/2020) was accompanied by an unprecedented number of calls to the French emergency service call number (15) of worried patients with overload and sometimes saturation of the service that can impact calls and the care of patients really recovering from an emergency.
We previously developed a Moovcare® web application which showed a 7 months survival benefit by early detection of relapsed lung cancer based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 trial randomized. Another application for detecting and monitoring chemo-induced febrile aplasia appears to show a reduction in the number of hospitalizations for sepsis. Finally, Smokecheck, a self-assessment application for symptoms by smokers, has shown that it improves the detection of symptomatic operable bronchial cancers (9 to 24%, p = 0.04).
The web application https://www.maladiecoronavirus.fr/ was developed with a group of physicians from the Institut Pasteur, Hospitals group of Paris, Hospitals of Lille and Rennes and the ILC Jean Bernard in Le Mans. It makes it possible to guide symptomatic patients and patients who wishing to know what to do (call their general practitioner, teleconsultation, or call emergency service) based on symptoms and predictive factors of severity.
Following the availability of this new tool, we want to assess the impact of the application on the number and relevance of calls to emergency service.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-application users | – | Device: Web application usersquestionnaire of comorbidity and symptomes completed by the user on his smartphone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All users of the https://www.maladiecoronavirus.fr/ application over the age of 18
Key inclusion criteria (1 listed)
- All users of the https://www.maladiecoronavirus.fr/ application over the age of 18
Key exclusion criteria (1 listed)
- not applicable
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 |
|---|---|---|
| Web application usersquestionnaire of comorbidity and symptoms completed by the patient on his smartphone | Device | Web-application users |
Primary outcome
To assess of the evolution of the number of calls to Emergency service within 12 days after the launch of the application https://www.maladiecoronavirus.fr/
Time frame: 12 days
Number of calls to Emergency service after the launch of web application comparded to the days before
To assess of the evolution of the proportion of relevant calls to Emergency service within 12 days after the launch of the application https://www.maladiecoronavirus.fr/
Time frame: 12 days
Number of relevants calls to Emergency service after the launch of web application comparded to the days before
4 secondary outcomes
To assess the evolution over time of the COVID 19 epidemic
Time frame: 3 months
To assess the evolution over space of the COVID 19 epidemic
Time frame: 3 months
To assess symptoms
Time frame: 3 months
To assess the users population
Time frame: 3 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 33709945Denis F, Fontanet A, Le Douarin YM, Le Goff F, Jeanneau S, Lescure FX. A Self-Assessment Web-Based App to Assess Trends of the COVID-19 Pandemic in France: Observational Study. J Med Internet Res. 2021 Mar 12;23(3):e26182. doi: 10.2196/26182.
- Derived from this study: PubMed 33147165Galmiche S, Rahbe E, Fontanet A, Dinh A, Benezit F, Lescure FX, Denis F. Implementation of a Self-Triage Web Application for Suspected COVID-19 and Its Impact on Emergency Call Centers: Observational Study. J Med Internet Res. 2020 Nov 23;22(11):e22924. doi: 10.2196/22924.
- Derived from this study: PubMed 32496206Denis F, Galmiche S, Dinh A, Fontanet A, Scherpereel A, Benezit F, Lescure FX. Epidemiological Observations on the Association Between Anosmia and COVID-19 Infection: Analysis of Data From a Self-Assessment Web Application. J Med Internet Res. 2020 Jun 11;22(6):e19855. doi: 10.2196/19855.
- 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
Jean Bernard Center - LE MANS
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 COVID-19, 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 1 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?
To assess of the evolution of the number of calls to Emergency service within 12 days after the launch of the application https://www.maladiecoronavirus.fr/ (time frame: 12 days). 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 NCT04331171, which also lists 3 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 8 Apr 2021.