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Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea (EPRICOD)

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ClinicalTrials.gov Identifier: NCT04422587
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment
Emergencies Other: RECOP unit patient

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1860 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Month
Official Title: Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea
Actual Study Start Date : March 13, 2020
Actual Primary Completion Date : June 5, 2020
Actual Study Completion Date : June 7, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea [ Time Frame: inclusion day ]
    demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor


Secondary Outcome Measures :
  1. Describe the characteristics of patients admitted to reCOP units according to their virological status [ Time Frame: 30 days ]
    The COVID-19 virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking

  2. Virological status [ Time Frame: 30 days ]
    Virological status will be collected by a phone call at the patient

  3. Mortality status [ Time Frame: 30 days ]
    Mortality status will be collected by a phone call at the patient



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422587


Locations
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France
University Hospital of Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Paul-Henri Auboiroux, MD University Hospital of Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04422587    
Other Study ID Numbers: RC31/20/0149
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
COVID-19
diagnostic strategy
acute dyspnea
Additional relevant MeSH terms:
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Dyspnea
Emergencies
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory