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NCT Number: NCT04629183

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Maria Vittoria, D.E.A., Turin, Piedmont, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

integrated clinical evaluation

Other

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

Other names: lung ultrasonosgraphy, chest radiography (standard care, clinical decision), blood testing (standard care, clinical decision)

Primary outcomes

  1. composite outcome

    Time frame: 30 days

    death (any cause), hospital admission (any cause)

Secondary outcomes

  1. death (COVID-19)

    Time frame: 30 days

    death for COVID-19

  2. death (other disease)

    Time frame: 30 days

    death for disease other than COVID-19

  3. hospital admission (COVID-19)

    Time frame: 30 days

    subsequent hospital admission for COVID-19

  4. hospital admission (other disease)

    Time frame: 30 days

    subsequent hospital admission for disease other than COVID-19

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Collaborators

  • University of Turin, Italy

Registry information

Acronym: CODED

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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