Predictors of Respiratory Failure in SARS-Cov-2 Infection

NCT ID: NCT04316949

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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SARS-CoV-2 Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Michele Bartoletti

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Bologna - Department of Medical and Surgical Sciences

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Pierluigi Viale, MD

Role: primary

+ 39 051 214 3018

References

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Bartoletti M, Giannella M, Scudeller L, Tedeschi S, Rinaldi M, Bussini L, Fornaro G, Pascale R, Pancaldi L, Pasquini Z, Trapani F, Badia L, Campoli C, Tadolini M, Attard L, Puoti M, Merli M, Mussini C, Menozzi M, Meschiari M, Codeluppi M, Barchiesi F, Cristini F, Saracino A, Licci A, Rapuano S, Tonetti T, Gaibani P, Ranieri VM, Viale P; PREDICO study group. Development and validation of a prediction model for severe respiratory failure in hospitalized patients with SARS-CoV-2 infection: a multicentre cohort study (PREDI-CO study). Clin Microbiol Infect. 2020 Nov;26(11):1545-1553. doi: 10.1016/j.cmi.2020.08.003. Epub 2020 Aug 8.

Reference Type DERIVED
PMID: 32781244 (View on PubMed)

Other Identifiers

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PREDI-CO

Identifier Type: -

Identifier Source: org_study_id

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