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Predicting Death and ICU Admission in COVID-19 Patients in ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04371562
Recruitment Status : Completed
First Posted : May 1, 2020
Last Update Posted : May 5, 2020
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:

INTRODUCTION. The novel coronavirus designated SARS-CoV-2, has determined an international outbreak of respiratory illness named Covid-19. Patients with Covid-19 present primarily with fever, myalgia or fatigue, and dry cough. Based on available data from 5% to 10% among hospitalized patients will require ICU admission.

In this context of overflow of critically ill patients, it is mandatory to establish clear and objective criteria to assess and predict a Covid-19 patient's need for ICU admission, and potentially predict death occurrence. Early Warning Scores (EWS) are used in hospitalized patients to predict clinical deterioration. Several study demonstrate the utility of EWS in ED to predict patient outcome.

AIM. The objective of this study is to evaluate five EWSs, to predict the need for ICU admission and the mortality in patients admitted in ED with COVID-19.

METHODS. This is a single-center, retrospective observational study. We will review the clinical records of all the patients consecutively admitted to our ED for Covid-19 over a three-weeks period (March 1 to 21, 2020). We will exclude from study cohort patients aged <18 years old and pregnant women, and patients already on oro-tracheal intubation at ED arrival. Based on clinical records five EWS will be calculated: NEWS, NEWS2, qSOFA, MEWS, REMS.

Study endpoints. The primary study endpoints will be death at 7 days, and need for ICU at 7 days, since ED admission. As secondary endpoints we will evaluate need for ICU and death at 24 and 48 hours since ED admission.

Statistical Analysis Receiver operating characteristic (ROC) curve analysis will be used to evaluate the overall performance of the selected EWSs in predicting the defined adverse outcomes. According to Youden's index we will estimate the optimal cut-off points and corresponding sensitivity and specificity at selected score threshold values. The comparison between the ROC AUCs will be made according to DeLong method.

Condition or disease

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predicting ICU Admission and Death for COVID-19 Patients in the Emergency Department. Comparison of Five Scoring Systems.
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : April 15, 2020

Primary Outcome Measures :
  1. 7-day death [ Time Frame: 7 day ]
    Death by seven day from ED access

  2. 7-day ICU [ Time Frame: 7 day ]
    Admission to ICU by seven day from ED access

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive COVID-19 patients admitted to ED

Inclusion Criteria:

  • COVID 19 confirmed patients.

Exclusion Criteria:

  • <18 years
  • Pregnant women
  • Asymptomatic and normal x-ray findings subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04371562

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Marcello Covino
Roma, RM, Italy, 0068
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Study Chair: Francesco Franceschi, MD PhD Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma

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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Identifier: NCT04371562    
Other Study ID Numbers: 0017055/20
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Early -Warning Scores