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NCT Number: NCT04307459

Acute Respiratory Failure and COVID-19 in Real Life

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.

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Key information

Conditions

Coronavirus Infections Coronaviridae Infections Infections Nidovirales Infections RNA Virus Infections Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Ventilator Lung Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luigi Sacco University Hospital

Milan, Lombardy, 20157, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard operating procedures

Other

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.

Primary outcomes

  1. 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

  1. in-hospital mortality

    Time frame: 1 month

    How many patients died during the hospitalization

  2. 30 days mortality

    Time frame: 1 month

    How many patients died 30 days after the discharge

  3. 6 months mortality

    Time frame: 6 months

    How many patients died 6 months after the discharge

  4. Intubation rate

    Time frame: 7 days

    How many patients were intubated during the hospitalization

  5. Time to Intubation

    Time frame: 7 days

    How many days/hours from admittance to intubation

  6. Time to ventilation

    Time frame: 7 days

    How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy

  7. Non invasive to Invasive time

    Time frame: 7 days

    How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation

  8. Recovery rate

    Time frame: 1 month

    How many patients were healed from the infection and discharged

  9. Recurrence rate

    Time frame: 1 month

    How many patients underwent re-infection after previous recovery from COVID19

  10. Risk factor for COVID19

    Time frame: retrospective

    Assessment of the risk factors for the infection and the admission to the hospital

  11. Blood tests and outcome

    Time frame: 1 month

    What serological parameter could be used as predictor of good or negative prognosis.

  12. Antiviral therapy

    Time frame: 1 month

    Impact of antiviral therapy on the clinical course of the disease

  13. Coinfections

    Time frame: 1 month

    Assessment of bacterial, fungal or other coinfections rate

  14. Radiological findings

    Time frame: 1 month

    Impact of radiological findings on the clinical course and the outcome

  15. Ultrasound findings

    Time frame: 1 month

    Impact of ultrasound findings on the clinical course and the outcome

  16. Myocardial injury

    Time frame: 1 month

    Assessment of the evidence of myocardial injury in covid19+ patients

  17. Medical management

    Time frame: 1 month

    impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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