NCT04422587

Brief Summary

This research aims to improve our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 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. A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However, virological tests do not currently allow rapid results for COVID-19. Research project of investigatory aims to develop a predictive model of the risk of being COVID-19 positive for patients admitted to the emergency room for acute dyspnea.

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
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

June 5, 2020

Last Update Submit

November 4, 2020

Conditions

Keywords

COVID-19diagnostic strategyacute dyspnea

Outcome Measures

Primary Outcomes (1)

  • Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea

    demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor

    inclusion day

Secondary Outcomes (3)

  • Describe the characteristics of patients admitted to reCOP units according to their virological status

    30 days

  • Virological status

    30 days

  • Mortality status

    30 days

Study Arms (1)

RECOP unit patient

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.

Other: RECOP unit patient

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.

RECOP unit patient

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 15 years 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

  • Paul-Henri Auboiroux, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

March 13, 2020

Primary Completion

June 5, 2020

Study Completion

June 7, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations