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Acute Respiratory Failure and COVID-19 in Real Life

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ClinicalTrials.gov Identifier: NCT04307459
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pierachille Santus, MD, PhD, University of Milan

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.


Condition or disease Intervention/treatment
Coronavirus Infections Respiratory Failure Ventilator Lung Other: standard operating procedures

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020


Group/Cohort Intervention/treatment
Coronavirus Infection
All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure
Other: standard operating procedures
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307459


Contacts
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Contact: Pierachille Santus, MD, PhD +390239042801 pierachille.santus@unimi.it
Contact: Elisa Franceschi, MD +390239042277 elisa.franceschi@unimi.it

Locations
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Italy
Luigi Sacco University Hospital Recruiting
Milan, Lombardia, Italy, 20157
Contact: Pierachille Santus, MD, PhD    0239042801    pierachille.santus@unimi.it   
Sub-Investigator: Elisa Franceschi, MD         
Sub-Investigator: Dejan Radovanovic, MD         
Principal Investigator: Pierachille Santus, MD PhD         
Sponsors and Collaborators
University of Milan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pierachille Santus, MD, PhD, Professor, Head of Respiratory Disease Unit H sacco, University of Milan
ClinicalTrials.gov Identifier: NCT04307459    
Other Study ID Numbers: 17263/2020
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierachille Santus, MD, PhD, University of Milan:
sars
acute respiratory failure
CPAP therapy
non invasive ventilation
gas exchange
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Insufficiency
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections