Acute Respiratory Failure and COVID-19 in Real Life

• Conditions: Ventilator Lung; Respiratory Failure; Coronavirus Infections
• Interventions: Other: standard operating procedures

• Registration Number: NCT04307459
• Lead Sponsor: University of Milan

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.

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 Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Study Start: 2020-03-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-13
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronavirus Infection	standard operating procedures	All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Luigi Sacco University Hospital; 🇮🇹 Milan, Lombardia, Italy