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.
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 Type
OBSERVATIONAL
Enrollment
50
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.
Luigi Sacco University Hospital
Milan, Lombardy, Italy
RECRUITINGReal 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
Time frame: 1-6 months
in-hospital mortality
How many patients died during the hospitalization
Time frame: 1 month
30 days mortality
How many patients died 30 days after the discharge
Time frame: 1 month
6 months mortality
How many patients died 6 months after the discharge
Time frame: 6 months
Intubation rate
How many patients were intubated during the hospitalization
Time frame: 7 days
Time to Intubation
How many days/hours from admittance to intubation
Time frame: 7 days
Time to ventilation
How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Time frame: 7 days
Non invasive to Invasive time
How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Time frame: 7 days
Recovery rate
How many patients were healed from the infection and discharged
Time frame: 1 month
Recurrence rate
How many patients underwent re-infection after previous recovery from COVID19
Time frame: 1 month
Risk factor for COVID19
Assessment of the risk factors for the infection and the admission to the hospital
Time frame: retrospective
Blood tests and outcome
What serological parameter could be used as predictor of good or negative prognosis.
Time frame: 1 month
Antiviral therapy
Impact of antiviral therapy on the clinical course of the disease
Time frame: 1 month
Coinfections
Assessment of bacterial, fungal or other coinfections rate
Time frame: 1 month
Radiological findings
Impact of radiological findings on the clinical course and the outcome
Time frame: 1 month
Ultrasound findings
Impact of ultrasound findings on the clinical course and the outcome
Time frame: 1 month
Myocardial injury
Assessment of the evidence of myocardial injury in covid19+ patients
Time frame: 1 month
Medical management
impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.
Time frame: 1 month
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