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

• Conditions: Covid19

• Registration Number: NCT04682093
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-03-09
• Status Verified: 2020-12
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-24
• Primary Completion: 2021-01-31
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
in-hospital mortality	30 days	Death during hospitalization
hospitalization	30 days	hospitalization after ED visit
ICU admission	30 days	ICU admission after ED visit
length of hospital stay	30 days	Hospital LOS

Trial Locations

Locations (1)

EUSEM RN Country lead; 🇮🇹 Forlì, Italy