NCT04371328

Brief Summary

This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units. The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units. This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,860

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 13, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

April 29, 2020

Last Update Submit

October 6, 2021

Conditions

Keywords

COVID 19aspecific respiratory symptomatology

Outcome Measures

Primary Outcomes (1)

  • Describe the characteristics of patients admitted to reCOP units according to their virological status vis-à-vis COVID-19

    The virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking

    30 days

Secondary Outcomes (1)

  • Develop a predictive model of the risk of being COVID for patients admitted to the emergency room for dyspnea

    0 days

Other Outcomes (2)

  • Virological status

    30 days

  • Mortality status

    30 days

Interventions

All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified. 30 days after inclusion, virological status and mortality will be collect

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial

You may qualify if:

  • All patients over the age of 15 admitted to the RECOP unit for dyspnea

You may not qualify if:

  • Patient admitted to shock for respiratory distress requiring immediate respiratory support.
  • Patient under justice safeguard

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

EmergenciesCOVID-19

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Frédéric Balen, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 1, 2020

Study Start

March 13, 2020

Primary Completion

June 5, 2020

Study Completion

June 30, 2020

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations