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Predictors of Respiratory Failure in SARS-Cov-2 Infection

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.
 
ClinicalTrials.gov Identifier: NCT04316949
Recruitment Status : Unknown
Verified April 2020 by Michele Bartoletti, University of Bologna.
Recruitment status was:  Recruiting
First Posted : March 20, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Michele Bartoletti, University of Bologna

Study Description
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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


Condition or disease
SARS-CoV-2 Pneumonia

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictors of Respiratory Failure Requiring ICU Admission Among Hospitalized Patients With SARS-Cov-2 Infection
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Derivation cohort

Derivation cohort: Italian retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from February 20 to March 19 2020.

.
Validation cohort
Validation cohort: European and non-European retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from March 19 to April 18 2020.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Occurence of bacterial superinfection [ Time Frame: 14 days ]
    Incidence of bacterial superinfection among ventilated patients with SARS-CoV-2 pneumonia


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population of the study will include all consecutive hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04316949


Locations
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Italy
University of Bologna - Department of Medical and Surgical Sciences Recruiting
Bologna, Italy, 40138
Contact: Pierluigi Viale, MD    + 39 051 214 3018    pierluigi.viale@unibo.it   
Sponsors and Collaborators
University of Bologna
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michele Bartoletti, Assistant Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT04316949    
Other Study ID Numbers: PREDI-CO
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Participant from other centers may request to analyze the registry for other purposes upon IRB and study group approval

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Infections
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections