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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04422587
Other study ID # RC31/20/0149
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2020
Est. completion date June 7, 2020

Study information

Verified date November 2020
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1860
Est. completion date June 7, 2020
Est. primary completion date June 5, 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - All patients over 15 years admitted to the RECOP unit for dyspnea Exclusion Criteria: - Patient admitted to shock for respiratory distress requiring immediate respiratory support. - Patient under justice safeguard

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France University Hospital of Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Describe the characteristics of patients admitted to reCOP units according to their virological status The COVID-19 virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking 30 days
Secondary Virological status Virological status will be collected by a phone call at the patient 30 days
Secondary Mortality status Mortality status will be collected by a phone call at the patient 30 days
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