Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316949
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Michele Bartoletti, University of Bologna

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.

Layout table for study information
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


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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location information
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders