Predictors of Respiratory Failure in SARS-Cov-2 Infection
1 other identifier
observational
350
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedStudy Start
First participant enrolled
March 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedApril 7, 2020
April 1, 2020
1 month
March 19, 2020
April 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Respiratory failure
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
14 days
Secondary Outcomes (1)
Occurence of bacterial superinfection
14 days
Study Arms (2)
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.
Eligibility Criteria
The population of the study will include all consecutive hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
You may qualify if:
- Hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
- Age \> 17 years
You may not qualify if:
- Invasive mechanical ventilation within 12 hours from hospital admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bologna - Department of Medical and Surgical Sciences
Bologna, 40138, Italy
Related Publications (1)
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.
PMID: 32781244DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 19, 2020
First Posted
March 20, 2020
Study Start
March 20, 2020
Primary Completion
April 30, 2020
Study Completion
May 31, 2020
Last Updated
April 7, 2020
Record last verified: 2020-04