Predictors of Respiratory Failure in SARS-Cov-2 Infection

SARS-CoV-2 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316949
• Other study ID #: PREDI-CO
• Status: Recruiting
• Start date: March 20, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: April 2020
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Respiratory Insufficiency
• SARS-CoV-2 Pneumonia

Locations

Country	Name	City	State
Italy	University of Bologna - Department of Medical and Surgical Sciences	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurence of bacterial superinfection	Incidence of bacterial superinfection among ventilated patients with SARS-CoV-2 pneumonia	14 days