Risk Stratification of COVID-19 Patients Discharged From the Emergency Department

Completed

• Conditions: Covid19

• Registration Number: NCT04629183
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief Summary

Risk stratification of COVID-19 patients is essential to define their appropriate treatment setting. So far, available studies have focused on morbidity and mortality prediction in patients admitted to hospital. In the Emergency Department (ED), decision on home discharge versus hospital admission for COVID-19 is cumbersome. While facing a dramatic second wave of SARS-CoV-2, shortage of hospital beds has further increased the challenge.

The present study will prospectively evaluate the clinical outcomes of patients discharged from the ED. Stratification will be based on a composite of demographic, clinical and lung imaging variables. Results will be used to develop standardized decision rules for safe home discharge of patients with COVID-19 evaluated in the ED.

Detailed Description

Patients with inclusion criteria and without exclusion criteria, evaluated in the participating EDs, will be enrolled in the study. Patients will undergo standard medical evaluation by the attending physician(s), following local guidelines and best medical practice, independent of participation to the study.

The following data will be recorded, when available:

* Demographic/clinical: age, gender, symptoms (type, time from onset), comorbidities, Glasgow Coma Scale score, respiratory rate, peripheral oxygen saturation

* Biochemical: urea, creatinine, C-reactive protein, procalcitonin, lactate dehydrogenase, white blood cell count, lymphocyte count, d-dimer

* Lung ultrasonography: site/type of B lines, consolidations, pleural effusion

* Radiology: chest X-ray result, chest CT result

Upon discharge, patients will be encouraged to contact emergency medical services or return the ED if needed, in case of clinical worsening.

The following endpoint will be assessed at 30 days after ED discharge, through standardized telephone interview and healthcare/other database query: any further hospital admission (for COVID-19 or other disease), death (for COVID-19 or other disease), respiratory failure/ventilation/intensive care admission (only for hospitalized COVID-19 patients).

Data analysis will focus on the outcome incidence in the study cohort, stratified by a composite of demographic/clinical, biochemical and imaging variables. A key stratification tool will be the 4C mortality score (BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3339). Additional integration of study variables will be evaluated to improve stratification and prediction.

Study Timeline

• Study Start: 2020-10-10
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Primary Completion: 2021-01-11
• Study Completion: 2021-02-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 742

Inclusion Criteria

• symptomatic COVID-19 confirmed by treating physician
• positive nasopharyngeal swab for SARS-CoV-2 (performed during the ED visit or within last 14 days)
• First ED visit for suspected or confirmed COVID-19 (within last 30 days)
• Home discharge from ED based on treating physician's or patient's decision

Exclusion Criteria

• Age <18 years
• Nursing home resident
• Already on home oxygen therapy
• Previous ED visit for suspected or confirmed COVID-19 (within last 30 days)
• Informed consent denial
• Follow-up not feasible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite outcome	30 days	death (any cause), hospital admission (any cause)

Secondary Outcome Measures

Name	Time	Method
death (COVID-19)	30 days	death for COVID-19
death (other disease)	30 days	death for disease other than COVID-19
hospital admission (COVID-19)	30 days	subsequent hospital admission for COVID-19
hospital admission (other disease)	30 days	subsequent hospital admission for disease other than COVID-19

Trial Locations

Locations (7)

A.O.U. Careggi, Medicina e Chirurgia d'Urgenza e Accettazione; 🇮🇹 Firenze, Italy

A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette, S.C. Medicina d'Urgenza U (MECAU); 🇮🇹 Torino, Italy

Ospedale Maria Vittoria, D.E.A.; 🇮🇹 Torino, Piemonte, Italy

Ospedale U. Parini, Medicina e Chirurgia d'accettazione e Urgenza (MeCAU); 🇮🇹 Aosta, Italy

Ospedale San Giovanni Bosco, Medicina e Chirurgia d'accettazione e urgenza (MeCAU); 🇮🇹 Torino, Italy

A.O.U.C. Azienda Ospedaliero-Universitaria Careggi, D.E.A.; 🇮🇹 Firenze, Toscana, Italy

A.O. S. Croce e Carle, Medicina e Chirurgia d'Urgenza; 🇮🇹 Cuneo, Italy