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
Overview
- Phase
- Not Applicable
- Intervention
- standard operating procedures
- Conditions
- Coronavirus Infections
- Sponsor
- University of Milan
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Status
- Completed
- Last Updated
- 3 days ago
Overview
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.
Investigators
Pierachille Santus, MD, PhD
Professor, Head of Respiratory Disease Unit H sacco
University of Milan
Eligibility Criteria
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
Arms & Interventions
Coronavirus Infection
All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure
Intervention: standard operating procedures
Outcomes
Primary Outcomes
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Time Frame: 1-6 months
Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome
Secondary Outcomes
- Recurrence rate(1 month)
- Risk factor for COVID19(retrospective)
- Ultrasound findings(1 month)
- 6 months mortality(6 months)
- Time to Intubation(7 days)
- Non invasive to Invasive time(7 days)
- in-hospital mortality(1 month)
- Coinfections(1 month)
- Medical management(1 month)
- Recovery rate(1 month)
- Antiviral therapy(1 month)
- 30 days mortality(1 month)
- Intubation rate(7 days)
- Time to ventilation(7 days)
- Blood tests and outcome(1 month)
- Myocardial injury(1 month)
- Radiological findings(1 month)