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

Completed

• Conditions: COVID-19

• Registration Number: NCT05465824
• Lead Sponsor: University Hospital, Tours

Brief Summary

Descriptive study of patients with suspected COVID-19 upon ED arrival of European hospitals between March 09 and April 08 2020.

Justification:

Detailed Description

Descriptive study of patients with suspected COVID-19 upon ED arrival of European hospitals between March 09 and April 08 2020.

Justification:

Over the past 3 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
• Primary Completion: 2020-04-08
• Study Completion: 2020-06-01
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7876

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

• No insurance
• patients less than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	through study completion, an average of 30 days	Mortality during hospital management

Trial Locations

Locations (1)

Tours University Hospital; 🇫🇷 Tours, France