Acute Respiratory Failure and COVID-19 in Real Life

NCT04307459 | Completed

• 1 other identifier: 17263/2020
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronavirus Infections; Respiratory Failure; Ventilator Lung

Keywords

sars; acute respiratory failure; CPAP therapy; non invasive ventilation; gas exchange

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• in-hospital mortality

  1 month

• 30 days mortality

  1 month

• 6 months mortality

  6 months

• Intubation rate

  7 days

• Time to Intubation

  7 days

Study Arms (1)

Coronavirus Infection

All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure

Other: standard operating procedures

Interventions

standard operating procedures OTHER

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.

Coronavirus Infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Luigi Sacco University Hospital

Milan, Lombardy, 20157, Italy

Location

Related Publications (1)

• 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.

  PMID: 33040020 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Respiratory Insufficiency; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Respiratory Disease Unit H sacco

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: March 19, 2020
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)