NCT04629183

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 742 (actual)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
OTHER	integrated clinical evaluation	30-day follow-up (telephone/database query) to define outcome Patients will receive standard care, independent of study participation.

Timeline

• Start date: 2020-10-10
• Primary completion: 2021-01-11
• Completion: 2021-02-11
• First posted: 2020-11-16
• Last updated: 2021-07-21

Locations

7 sites across 1 country: Italy