NCT04670003

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,975

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

January 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

April 8, 2021

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 14, 2020

Last Update Submit

April 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Description of the methods of contamination of patients

    Data and symptomes collected by the web applications self-questionnaire (patient reported outcome)

    2 months

Secondary Outcomes (2)

  • Evaluation in time of the spread of the virus during the 2nd epidemic wave.

    2 months

  • Evaluation in space of the spread of the virus during the 2nd epidemic wave.

    2 months

Study Arms (1)

users

users of web-application

Other: users

Interventions

usersOTHER

Data of users of the web-application

users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All users of the application contaminated with COVID 19 who have not objected to the use of their data

You may qualify if:

  • users of the application
  • not having objected to the use of their data

You may not qualify if:

  • \- user who does not have a complete questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Interrégional de Cancérologie

Le Mans, 72000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Fabrice DENIS, MD

    Institut Interrégional de Cancerologie et Kelindi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 17, 2020

Study Start

January 2, 2021

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

April 8, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations