Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage

COVID-19 Clinical Trial

— COVID CALL 15  

Official title:

Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331171
• Other study ID #: WP-2020-02
• Status: Completed
• Start date: March 17, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: April 2021
• Source: Weprom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000000
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All users of the https://www.maladiecoronavirus.fr/ application over the age of 18

Exclusion Criteria:

• not applicable

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Web application users
questionnaire of comorbidity and symptoms completed by the patient on his smartphone

Locations

Country	Name	City	State
France	All French Emergency services	Le Mans

Sponsors (5)

Lead Sponsor	Collaborator
Weprom	Assistance Publique - Hôpitaux de Paris, Direction Générale de l'Offre de Soins, DOCAPOST, Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 days
Primary	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	12 days
Secondary	To assess the evolution over time of the COVID 19 epidemic	the symptoms collected by the application	3 months
Secondary	To assess the evolution over space of the COVID 19 epidemic	the symptoms collected by the application according to ZIP code	3 months
Secondary	To assess symptoms	Descriptive analysis of symptoms collected by web-application	3 months
Secondary	To assess the users population	Descriptive analysis of data collected by web-application	3 months