Clinical Trials Directory

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UnknownNCT04307459

Acute Respiratory Failure and COVID-19 in Real Life

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

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
University of Milan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERstandard operating proceduresstandard 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.

Timeline

Start date
2020-03-19
Primary completion
2020-09-01
Completion
2020-12-31
First posted
2020-03-13
Last updated
2020-05-13

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04307459. Inclusion in this directory is not an endorsement.