Acute Respiratory Failure and COVID-19 in Real Life

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307459
• Other study ID #: 17263/2020
• Status: Recruiting
• Start date: March 19, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: University of Milan
• Contact: Pierachille Santus, MD, PhD
• Phone: +390239042801
• Email: pierachille.santus[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Infection
• Respiratory Failure
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome
• Ventilator Lung

Intervention

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.

Locations

Country	Name	City	State
Italy	Luigi Sacco University Hospital	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

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