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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: integrated clinical evaluation

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 Type: Observational
• Enrollment (Actual): 742

Contacts and Locations

Study Locations

• Italy
  • Aosta, Italy
    • Ospedale U. Parini, Medicina e Chirurgia d'accettazione e Urgenza (MeCAU)
  • Cuneo, Italy, 12100
    • A.O. S. Croce e Carle, Medicina e Chirurgia d'Urgenza
  • Firenze, Italy
    • A.O.U. Careggi, Medicina e Chirurgia d'Urgenza e Accettazione
  • Torino, Italy, 10126
    • A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette, S.C. Medicina d'Urgenza U (MECAU)
  • Torino, Italy
    • Ospedale San Giovanni Bosco, Medicina e Chirurgia d'accettazione e urgenza (MeCAU)
  • Piemonte
    • Torino, Piemonte, Italy, 10128
      • Ospedale Maria Vittoria, D.E.A.
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • A.O.U.C. Azienda Ospedaliero-Universitaria Careggi, D.E.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (>18 years) subjected to a first ED visit for physician-confirmed COVID-19, discharged from the ED based on attending physician's or patient's decision (independent from study participation). Patients will provide their informed consent to participation (thus allowing clinical data recording and 30-day follow-up).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite outcome	death (any cause), hospital admission (any cause)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death (COVID-19)	death for COVID-19	30 days
death (other disease)	death for disease other than COVID-19	30 days
hospital admission (COVID-19)	subsequent hospital admission for COVID-19	30 days
hospital admission (other disease)	subsequent hospital admission for disease other than COVID-19	30 days

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Collaborators: University of Turin, Italy
• Investigators: Principal Investigator: Fulvio Morello, MD, PhD, A.O.U. Città della Salute e Della Scienza di Torino

Publications and helpful links

General Publications

• Knight SR, Ho A, Pius R, Buchan I, Carson G, Drake TM, Dunning J, Fairfield CJ, Gamble C, Green CA, Gupta R, Halpin S, Hardwick HE, Holden KA, Horby PW, Jackson C, Mclean KA, Merson L, Nguyen-Van-Tam JS, Norman L, Noursadeghi M, Olliaro PL, Pritchard MG, Russell CD, Shaw CA, Sheikh A, Solomon T, Sudlow C, Swann OV, Turtle LC, Openshaw PJ, Baillie JK, Semple MG, Docherty AB, Harrison EM; ISARIC4C investigators. Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. BMJ. 2020 Sep 9;370:m3339. doi: 10.1136/bmj.m3339. Erratum In: BMJ. 2020 Nov 13;371:m4334.
• Pivetta E, Goffi A, Tizzani M, Locatelli SM, Porrino G, Losano I, Leone D, Calzolari G, Vesan M, Steri F, Arianna A, Capuano M, Gelardi M, Silvestri G, Dutto S, Avolio M, Cavallo R, Bartalucci A, Paglieri C, Morello F, Richiardi L, Maule MM, Lupia E, on behalf of the Molinette MedUrg Group on Lung Ultrasound. Lung ultrasound for the diagnosis of SARS-CoV-2 pneumonia in the Emergency Department. https://doi.org/10.1016/j.annemergmed.2020.10.008
• Liu RB, Tayal VS, Panebianco NL, Tung-Chen Y, Nagdev A, Shah S, Pivetta E, Henwood PC, Nelson MJ, Moore CL. Ultrasound on the Frontlines of COVID-19: Report From an International Webinar. Acad Emerg Med. 2020 Jun;27(6):523-526. doi: 10.1111/acem.14004. Epub 2020 Jun 9. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): February 11, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: emergency department; risk; discharge; admission
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Emergencies
• Other Study ID Numbers: COVID-ED-IntRisk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No