Acute Respiratory Failure and COVID-19 in Real Life

Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation

In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe.

No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19).

The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infections; Respiratory Failure; Ventilator Lung
• Intervention / Treatment: Other: standard operating procedures

Detailed Description

All consecutive adult COVID-19 patients admitted to our Respiratory Unit will be enrolled. All demographic, anthropometric, laboratory, radiological, clinical and microbiological data will be collected and analyzed according to the primary and secondary outcomes (see the dedicated section).

During the hospitalization, patients will be treated according to the standard operating procedure of our Respiratory Unit, such as arterial gas analysis, Rx, pharmacological treatment, ventilation. This study is purely observational and no randomization will be performed.

After discharge, patients a 7 days, 30 days and 6 months follow up will be assessed.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20157
      • Luigi Sacco University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with SARS-CoV2 pulmonary disease admitted to the H. Sacco respiratory unit will be enrolled in the observational study (see exclusion criteria).

Description

Inclusion Criteria:

• Patients that can give written or oral informed consent
• patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection

Exclusion Criteria:

• severe cognitive impairment
• absolute contraindication to non invasive ventilation or cpap therapy
• rhinopharyngeal swab negative for SARS-CoV2

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronavirus Infection; All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure	Other: standard operating procedures; standard operating procedures represented by continuous positive airway pressure (CPAP) therapy or non invasive ventilation, pharmacological treatment as antiviral and antibiotic drugs, bronchodilators, xanthines, enteral nutrition, hydration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection	Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome	1-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in-hospital mortality	How many patients died during the hospitalization	1 month
30 days mortality	How many patients died 30 days after the discharge	1 month
6 months mortality	How many patients died 6 months after the discharge	6 months
Intubation rate	How many patients were intubated during the hospitalization	7 days
Time to Intubation	How many days/hours from admittance to intubation	7 days
Time to ventilation	How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy	7 days
Non invasive to Invasive time	How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation	7 days
Recovery rate	How many patients were healed from the infection and discharged	1 month
Recurrence rate	How many patients underwent re-infection after previous recovery from COVID19	1 month
Risk factor for COVID19	Assessment of the risk factors for the infection and the admission to the hospital	retrospective
Blood tests and outcome	What serological parameter could be used as predictor of good or negative prognosis.	1 month
Antiviral therapy	Impact of antiviral therapy on the clinical course of the disease	1 month
Coinfections	Assessment of bacterial, fungal or other coinfections rate	1 month
Radiological findings	Impact of radiological findings on the clinical course and the outcome	1 month
Ultrasound findings	Impact of ultrasound findings on the clinical course and the outcome	1 month
Myocardial injury	Assessment of the evidence of myocardial injury in covid19+ patients	1 month
Medical management	impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.	1 month

Collaborators and Investigators

• Sponsor: University of Milan

Publications and helpful links

General Publications

• Santus P, Radovanovic D, Saderi L, Marino P, Cogliati C, De Filippis G, Rizzi M, Franceschi E, Pini S, Giuliani F, Del Medico M, Nucera G, Valenti V, Tursi F, Sotgiu G. Severity of respiratory failure at admission and in-hospital mortality in patients with COVID-19: a prospective observational multicentre study. BMJ Open. 2020 Oct 10;10(10):e043651. doi: 10.1136/bmjopen-2020-043651.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: non invasive ventilation; acute respiratory failure; gas exchange; CPAP therapy; sars
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; Respiratory Insufficiency; Coronavirus Infections; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: 17263/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No