Coronavirus InfectionsNCT04307459
Acute Respiratory Failure and COVID-19 in Real Life
An observational study of Coronavirus Infections and Respiratory Failure, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections, Respiratory Failure, Ventilator Lung
- What is being tested?
- standard operating procedures
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 19 Mar 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients that can give written or oral informed consent
- patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection
Who cannot join
- severe cognitive impairment
- absolute contraindication to non invasive ventilation or cpap therapy
- rhinopharyngeal swab negative for SARS-CoV2
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Coronavirus Infections, Respiratory Failure, Ventilator Lung
- Being tested
- standard operating procedures
- Keywords
- sars, acute respiratory failure, CPAP therapy, non invasive ventilation, gas exchange
- Medical subject headings
- Coronavirus Infections, Respiratory Insufficiency, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard operating proceduresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Coronavirus Infection | All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure Receives: Other: standard operating procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome
Measured: 1-6 months
Secondary outcomes (17)
in-hospital mortality
How many patients died during the hospitalization
Measured: 1 month
30 days mortality
How many patients died 30 days after the discharge
Measured: 1 month
6 months mortality
How many patients died 6 months after the discharge
Measured: 6 months
Intubation rate
How many patients were intubated during the hospitalization
Measured: 7 days
Time to Intubation
How many days/hours from admittance to intubation
Measured: 7 days
Time to ventilation
How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
Measured: 7 days
Non invasive to Invasive time
How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
Measured: 7 days
Recovery rate
How many patients were healed from the infection and discharged
Measured: 1 month
Recurrence rate
How many patients underwent re-infection after previous recovery from COVID19
Measured: 1 month
Risk factor for COVID19
Assessment of the risk factors for the infection and the admission to the hospital
Measured: retrospective
Blood tests and outcome
What serological parameter could be used as predictor of good or negative prognosis.
Measured: 1 month
Antiviral therapy
Impact of antiviral therapy on the clinical course of the disease
Measured: 1 month
Coinfections
Assessment of bacterial, fungal or other coinfections rate
Measured: 1 month
Radiological findings
Impact of radiological findings on the clinical course and the outcome
Measured: 1 month
Ultrasound findings
Impact of ultrasound findings on the clinical course and the outcome
Measured: 1 month
Myocardial injury
Assessment of the evidence of myocardial injury in covid19+ patients
Measured: 1 month
Medical management
impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start19 Mar 2020
- Primary completion1 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierachille Santus, MD, PhD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307459
- Sponsor's protocol ID
- 17263/2020
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santus P, Radovanovic D, Saderi L, Marino P, Cogliati C, De Filippis G, Rizzi M, Franceschi E, Pini S, Giuliani F, Del Medico M, Nucera G, Valenti V, Tursi F, Sotgiu G. Severity of respiratory failure at admission and in-hospital mortality in patients with COVID-19: a prospective observational multicentre study. BMJ Open. 2020 Oct 10;10(10):e043651. doi: 10.1136/bmjopen-2020-043651.
PubMed 33040020
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04307459
- Acronym / sponsor ID
- 17263/2020
- Conditions
- Coronavirus Infections, Respiratory Failure, Ventilator Lung
- Keywords
- sars, acute respiratory failure, CPAP therapy, non invasive ventilation, gas exchange
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronavirus Infection | – | Other: standard operating proceduresAll patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Patients that can give written or oral informed consent
- patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection
Key exclusion criteria (3 listed)
- severe cognitive impairment
- absolute contraindication to non invasive ventilation or cpap therapy
- rhinopharyngeal swab negative for SARS-CoV2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard 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. | Other | Coronavirus Infection |
Primary outcome
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
17 secondary outcomes
in-hospital mortality
Time frame: 1 month
30 days mortality
Time frame: 1 month
6 months mortality
Time frame: 6 months
Intubation rate
Time frame: 7 days
Time to Intubation
Time frame: 7 days
Time to ventilation
Time frame: 7 days
Non invasive to Invasive time
Time frame: 7 days
Recovery rate
Time frame: 1 month
Recurrence rate
Time frame: 1 month
Risk factor for COVID19
Time frame: retrospective
Blood tests and outcome
Time frame: 1 month
Antiviral therapy
Time frame: 1 month
Coinfections
Time frame: 1 month
Radiological findings
Time frame: 1 month
Ultrasound findings
Time frame: 1 month
Myocardial injury
Time frame: 1 month
Medical management
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 33040020Santus P, Radovanovic D, Saderi L, Marino P, Cogliati C, De Filippis G, Rizzi M, Franceschi E, Pini S, Giuliani F, Del Medico M, Nucera G, Valenti V, Tursi F, Sotgiu G. Severity of respiratory failure at admission and in-hospital mortality in patients with COVID-19: a prospective observational multicentre study. BMJ Open. 2020 Oct 10;10(10):e043651. doi: 10.1136/bmjopen-2020-043651.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections and Respiratory Failure, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (time frame: 1-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04307459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.