EUROCOV: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED

Sponsor
European Society for Emergency Medicine (EUSEM) Research Network (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04682093
Collaborator
(none)
8,000
5
11.7
1600
136.8

Study Details

Study Description

Brief Summary

This project is an unfunded collaboration of approximately 30 emergency departments across Europe led by the EUSEM research network. It involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected Covid infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Over the past 6 months, the world has faced a novel infection disease outbreak, due to a novel coronavirus, the severe acute respiratory syndrome coronavirus (SARS-CoV2), with a massive impact on healthcare resource.

    In Europe, numbers of confirmed cases continue to rise. Europe is currently one of the regions with the highest number of Covid-19 cases and deaths due to this emergent diseases.

    Most COVID-19 infected patients present with mild to moderate acute respiratory symptoms, including cough, fever, dyspnea and pneumonia. About 20% will present with severe or critical manifestations of the disease, including pneumonia, respiratory failure and acute respiratory distress syndrome (ARDS).

    Anticipating the needs for hospitalization in ward and/or intensive care is crucial.

    Emergency departments are at the front line for triaging patients with suspected Covid-19 and referring them to the appropriate level of care.

    In Europe, the number of ED patients with suspected Covid-19 is variable; rate of hospitalization from ED reaches 40% for this population.

    Risk stratification and management decisions of patients presenting to the ED with suspected COVID-19 is a challenge for emergency physicians.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    8000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)
    Actual Study Start Date :
    Mar 9, 2020
    Anticipated Primary Completion Date :
    Jan 31, 2021
    Anticipated Study Completion Date :
    Feb 28, 2021

    Outcome Measures

    Primary Outcome Measures

    1. hospitalization [30 days]

      hospitalization after ED visit

    2. length of hospital stay [30 days]

      Hospital LOS

    3. in-hospital mortality [30 days]

      Death during hospitalization

    4. ICU admission [30 days]

      ICU admission after ED visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients (>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria

    • Fever >= 38 °C

    • respiratory symptoms (dyspnea, cough, expectorations)

    • any other symptoms suggestive of COVID-19 including digestive signs (diarrhea, anosmia…)

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EUSEM RN Country lead Zagreb Croatia
    2 EUSEM RN Country lead Hämeenlinna Finland
    3 EUSEM RN Country lead Tours France
    4 EUSEM RN Country lead Athens Greece
    5 EUSEM RN Country lead Forlì Italy

    Sponsors and Collaborators

    • European Society for Emergency Medicine (EUSEM) Research Network

    Investigators

    • Principal Investigator: Said LARIBI, MD, PhD, EUSEM Research network chair

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    European Society for Emergency Medicine (EUSEM) Research Network
    ClinicalTrials.gov Identifier:
    NCT04682093
    Other Study ID Numbers:
    • 123456
    First Posted:
    Dec 23, 2020
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by European Society for Emergency Medicine (EUSEM) Research Network
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 24, 2020