Acute Respiratory Failure and COVID-19 in Real Life
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| ClinicalTrials.gov Identifier: NCT04307459 |
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Recruitment Status :
Recruiting
First Posted : March 13, 2020
Last Update Posted : May 13, 2020
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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 |
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.
| 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 |
|---|---|
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Coronavirus Infection
All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure
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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. |
- 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
- in-hospital mortality [ Time Frame: 1 month ]How many patients died during the hospitalization
- 30 days mortality [ Time Frame: 1 month ]How many patients died 30 days after the discharge
- 6 months mortality [ Time Frame: 6 months ]How many patients died 6 months after the discharge
- Intubation rate [ Time Frame: 7 days ]How many patients were intubated during the hospitalization
- Time to Intubation [ Time Frame: 7 days ]How many days/hours from admittance to intubation
- Time to ventilation [ Time Frame: 7 days ]How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
- 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
- Recovery rate [ Time Frame: 1 month ]How many patients were healed from the infection and discharged
- Recurrence rate [ Time Frame: 1 month ]How many patients underwent re-infection after previous recovery from COVID19
- Risk factor for COVID19 [ Time Frame: retrospective ]Assessment of the risk factors for the infection and the admission to the hospital
- Blood tests and outcome [ Time Frame: 1 month ]What serological parameter could be used as predictor of good or negative prognosis.
- Antiviral therapy [ Time Frame: 1 month ]Impact of antiviral therapy on the clinical course of the disease
- Coinfections [ Time Frame: 1 month ]Assessment of bacterial, fungal or other coinfections rate
- Radiological findings [ Time Frame: 1 month ]Impact of radiological findings on the clinical course and the outcome
- Ultrasound findings [ Time Frame: 1 month ]Impact of ultrasound findings on the clinical course and the outcome
- Myocardial injury [ Time Frame: 1 month ]Assessment of the evidence of myocardial injury in covid19+ patients
- Medical management [ Time Frame: 1 month ]impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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
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
| Contact: Pierachille Santus, MD, PhD | +390239042801 | pierachille.santus@unimi.it | |
| Contact: Elisa Franceschi, MD | +390239042277 | elisa.franceschi@unimi.it |
| 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 | |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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sars acute respiratory failure CPAP therapy non invasive ventilation gas exchange |
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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 |