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

Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zagreb, Croatia
        • EUSEM RN Country lead
      • Hämeenlinna, Finland
        • EUSEM RN Country lead
      • Tours, France
        • EUSEM RN Country lead
      • Athens, Greece
        • EUSEM RN Country lead
      • Forlì, Italy
        • EUSEM RN Country lead

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- Adult patients (>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalization
Time Frame: 30 days
hospitalization after ED visit
30 days
length of hospital stay
Time Frame: 30 days
Hospital LOS
30 days
in-hospital mortality
Time Frame: 30 days
Death during hospitalization
30 days
ICU admission
Time Frame: 30 days
ICU admission after ED visit
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

February 28, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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