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Clinical Trials/NCT04316949
NCT04316949
Unknown
Not Applicable

Predictors of Respiratory Failure Requiring ICU Admission Among Hospitalized Patients With SARS-Cov-2 Infection

University of Bologna1 site in 1 country350 target enrollmentMarch 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS-CoV-2 Pneumonia
Sponsor
University of Bologna
Enrollment
350
Locations
1
Primary Endpoint
Respiratory failure
Last Updated
6 years ago

Overview

Brief Summary

The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia.

A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy

Detailed Description

The study will compared patients with and without respiratory failure in order to find risk factors for need for ICU admission. A simple score based on risk factors will be created from a multicenter Italian cohort and validated in a multicenter international cohort.

Registry
clinicaltrials.gov
Start Date
March 20, 2020
End Date
May 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Bologna
Responsible Party
Principal Investigator
Principal Investigator

Michele Bartoletti

Assistant Professor

University of Bologna

Eligibility Criteria

Inclusion Criteria

  • Hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
  • Age \> 17 years

Exclusion Criteria

  • Invasive mechanical ventilation within 12 hours from hospital admission

Outcomes

Primary Outcomes

Respiratory failure

Time Frame: 14 days

Composite of ICU admission or SpO2\<92% with 100% FiO2 of oxygen treatment (reservoir mask or CPAP or NIV), respiratory rate \>30 bpm, respiratory distress

Secondary Outcomes

  • Occurence of bacterial superinfection(14 days)

Study Sites (1)

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