CI

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ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT04371562
NCT04371562N/ACompleted

Predicting ICU Admission and Death for COVID-19 Patients in the Emergency Department. Comparison of Five Scoring Systems.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·observational·Posted May 1, 2020·Updated May 5, 2020

In Brief

An observational study for COVID. Completed, enrolled 300 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 1, 2020
Enrollment StartMar 1, 2020
Primary CompletionMar 31, 2020
Study CompletionApr 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.2 years ago