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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04629183
Acronym
CODED
Enrollment
742
Registered
2020-11-16
Start date
2020-10-10
Completion date
2021-02-11
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

emergency department, admission, discharge, risk

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.

Interventions

OTHERintegrated clinical evaluation

30-day follow-up (telephone/database query) to define outcome Patients will receive standard care, independent of study participation.

Sponsors

University of Turin, Italy
CollaboratorOTHER
A.O.U. Città della Salute e della Scienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
composite outcome30 daysdeath (any cause), hospital admission (any cause)

Secondary

MeasureTime frameDescription
death (COVID-19)30 daysdeath for COVID-19
death (other disease)30 daysdeath for disease other than COVID-19
hospital admission (COVID-19)30 dayssubsequent hospital admission for COVID-19
hospital admission (other disease)30 dayssubsequent hospital admission for disease other than COVID-19

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026