Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682093
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
European Society for Emergency Medicine (EUSEM) Research Network

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
Covid19

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.

Layout table for study information
Study Type : Observational
Estimated 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 : March 9, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021



Primary Outcome Measures :
  1. hospitalization [ Time Frame: 30 days ]
    hospitalization after ED visit

  2. length of hospital stay [ Time Frame: 30 days ]
    Hospital LOS

  3. in-hospital mortality [ Time Frame: 30 days ]
    Death during hospitalization

  4. ICU admission [ Time Frame: 30 days ]
    ICU admission after ED visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

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): NCT04682093


Locations
Layout table for location information
Croatia
EUSEM RN Country lead
Zagreb, Croatia
Finland
EUSEM RN Country lead
Hämeenlinna, Finland
France
EUSEM RN Country lead
Tours, France
Greece
EUSEM RN Country lead
Athens, Greece
Italy
EUSEM RN Country lead
Forlì, Italy
Sponsors and Collaborators
European Society for Emergency Medicine (EUSEM) Research Network
Investigators
Layout table for investigator information
Principal Investigator: Said LARIBI, MD, PhD EUSEM Research network chair
Publications:

Layout table for additonal information
Responsible Party: European Society for Emergency Medicine (EUSEM) Research Network
ClinicalTrials.gov Identifier: NCT04682093    
Other Study ID Numbers: 123456
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020

Layout table for additional information
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:
Covid19
Emergencies
epidemiology
prognosis