Acute Respiratory Failure and COVID-19 in Real Life

Sponsor

University of Milan (Other)

Overall Status

Unknown status

CT.gov ID

NCT04307459

Collaborator

(none)

Enrollment

Location

9.4

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infections Respiratory Failure Ventilator Lung	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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 19, 2020

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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