Acute Respiratory Failure and COVID-19 in Real Life

University of Milan

Status: Unknown

Conditions: Respiratory Failure; Ventilator Lung; Coronavirus Infections

Treatments: Other: standard operating procedures

Study type: Observational

Funder types: Other

Identifiers

NCT04307459

17263/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Coronavirus Infection

Description:

All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure

Treatment:

Other: standard operating procedures