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

Covid19 Clinical Trial

— CODED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629183
• Other study ID #: COVID-ED-IntRisk
• Status: Completed
• Start date: October 10, 2020
• Est. completion date: February 11, 2021

Study information

• Verified date: July 2021
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: February 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Emergencies

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale U. Parini, Medicina e Chirurgia d'accettazione e Urgenza (MeCAU)	Aosta
Italy	A.O. S. Croce e Carle, Medicina e Chirurgia d'Urgenza	Cuneo
Italy	A.O.U. Careggi, Medicina e Chirurgia d'Urgenza e Accettazione	Firenze
Italy	A.O.U.C. Azienda Ospedaliero-Universitaria Careggi, D.E.A.	Firenze	Toscana
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 San Giovanni Bosco, Medicina e Chirurgia d'accettazione e urgenza (MeCAU)	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino	University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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, — View Citation

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. Ep — View Citation

Pivetta E, Goffi A, Tizzani M, Locatelli SM, Porrino G, Losano I, Leone D, Calzolari G, Vesan M, Steri F, Ardito 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; Molinette MedUrg Group on Lung Ultrasound. Lung Ultrasonography for the Diagnosis of SARS-CoV-2 Pneumonia in the Emergency Department. Ann Emerg Med. 2021 Apr;77(4):385-394. doi: 10.1016/j.annemergmed.2020.10.008. Epub 2020 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcome	death (any cause), hospital admission (any cause)	30 days
Secondary	death (COVID-19)	death for COVID-19	30 days
Secondary	death (other disease)	death for disease other than COVID-19	30 days
Secondary	hospital admission (COVID-19)	subsequent hospital admission for COVID-19	30 days
Secondary	hospital admission (other disease)	subsequent hospital admission for disease other than COVID-19	30 days