Clinical trial NCT04307459: Acute Respiratory Failure and COVID-19 in Real Life
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infections
Respiratory Failure
Ventilator Lung
Keywords: sars
acute respiratory failure
CPAP therapy
non invasive ventilation
gas exchange
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with SARS-CoV2 pulmonary disease admitted to the H. Sacco respiratory unit will be enrolled in the observational study (see exclusion criteria).

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.

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

Primary outcomes:
measure: Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
timeFrame: 1-6 months
Secondary outcomes:
measure: in-hospital mortality
timeFrame: 1 month
measure: 30 days mortality
timeFrame: 1 month
measure: 6 months mortality
timeFrame: 6 months
measure: Intubation rate
timeFrame: 7 days
measure: Time to Intubation
timeFrame: 7 days
measure: Time to ventilation
timeFrame: 7 days
measure: Non invasive to Invasive time
timeFrame: 7 days
measure: Recovery rate
timeFrame: 1 month
measure: Recurrence rate
timeFrame: 1 month
measure: Risk factor for COVID19
timeFrame: retrospective
measure: Blood tests and outcome
timeFrame: 1 month
measure: Antiviral therapy
timeFrame: 1 month
measure: Coinfections
timeFrame: 1 month
measure: Radiological findings
timeFrame: 1 month
measure: Ultrasound findings
timeFrame: 1 month
measure: Myocardial injury
timeFrame: 1 month
measure: Medical management
timeFrame: 1 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Luigi Sacco University Hospital
state: Lombardia
Study officials:
References:
citation: Santus P, Radovanovic D, Saderi L, Marino P, Cogliati C, De Filippis G, Rizzi M, Franceschi E, Pini S, Giuliani F, Del Medico M, Nucera G, Valenti V, Tursi F, Sotgiu G. Severity of respiratory failure at admission and in-hospital mortality in patients with COVID-19: a prospective observational multicentre study. BMJ Open. 2020 Oct 10;10(10):e043651. doi: 10.1136/bmjopen-2020-043651.