COVID-19NCT05077319
Characteristics and Outcome of Patients With COVID-19 in ICUs in South Tyrol
An observational study of COVID-19 and COVID-19 Acute Respiratory Distress Syndrome, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial summary
The investigators retrospectively investigate the epidemiology, clinical characteristics and therapeutic interventions of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID-19 Acute Respiratory Distress Syndrome
- How many people
- 550 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2020to 4 Oct 2021
- 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: Patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure
Who may be able to join
- All patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure
Who cannot join
- SARS-CoV-2 patients admitted to the intensive care units in South Tyrol for other pathologies (i.e., not respiratory failure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Outcome of Patients With COVID-19 Associated Respiratory Failure Treated in South Tyrol, Italy
The investigators retrospectively investigate the epidemiology, clinical characteristics and therapeutic interventions of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy.
Read the detailed description
In this observational, retrospective study the epidemiology, characteristics, therapeutic interventions and outcome of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy, are assessed. Data extracted from the medical patients' records include type and duration of respiratory support (high-flow nasal oxygen, non-invasive ventilation, invasive ventilation), need for tracheostomy, vasopressor needs, antibiotic therapy, corticosteroid treatment, laboratory values (interleukin-6, C-reactive protein, procalcitonin, D-dimer, lymphocyte count), lengths of stay in the ICU and mortality.
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality (dead/alive) at discharge from the ICU is defined as primary outcome
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start5 Mar 2020
- Primary completion20 Sep 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Retrospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria dell'Alto Adige
- Responsible party
- Principal investigator, Simon Rauch, Institute of Mountain Emergency Medicine
- Investigators
- Simon Rauch, MD, PhD, Principal investigator, Institute of Mountain Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077319
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcome of Patients With COVID-19 Associated Respiratory Failure Treated in South Tyrol, Italy
- ClinicalTrials.gov ID
- NCT05077319
- Acronym / sponsor ID
- 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Collaborators
- Azienda Sanitaria dell'Alto Adige
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 14 Oct 2021 (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.
The investigators retrospectively investigate the epidemiology, clinical characteristics and therapeutic interventions of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy.
Detailed description
In this observational, retrospective study the epidemiology, characteristics, therapeutic interventions and outcome of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy, are assessed. Data extracted from the medical patients' records include type and duration of respiratory support (high-flow nasal oxygen, non-invasive ventilation, invasive ventilation), need for tracheostomy, vasopressor needs, antibiotic therapy, corticosteroid treatment, laboratory values (interleukin-6, C-reactive protein, procalcitonin, D-dimer, lymphocyte count), lengths of stay in the ICU and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure
Key inclusion criteria (1 listed)
- All patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure
Key exclusion criteria (1 listed)
- SARS-CoV-2 patients admitted to the intensive care units in South Tyrol for other pathologies (i.e., not respiratory failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Through study completion, an average of 1 year
Mortality (dead/alive) at discharge from the ICU is defined as primary outcome
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 14 Oct 2021.
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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.
Simon Rauch, MD, PhD principal investigator
Institute of Mountain Emergency Medicine
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 COVID-19 and COVID-19 Acute Respiratory Distress Syndrome, run by Institute of Mountain Emergency Medicine 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 1 inclusion and 1 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 14 Oct 2021. 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?
Mortality (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.