Covid19CATCOVID-AIRNCT04668196
Noninvasive Respiratory Support in COVID-19 (CATCOVID-AIR)
An observational study of Covid19 and Acute Respiratory Failure, run by Hospital Universitari Vall d'Hebron Research Institute at 10 sites in Spain.
Trial summary
COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Acute Respiratory Failure, Corona Virus Infection
- What is being tested?
- High-flow nasal cannula treatment, Continuous positive airway pressure (CPAP) treatment and Noninvasive ventilation treatment
- Type of treatment
- Medical device
- How many people
- 367 participants
- Where
- 10 sitesSpain
- Study dates
- 22 May 2020to 25 Jan 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: COVID19 patients treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP, or noninvasive ventilation), initiated outside the intensive care unit.
Who may be able to join
- COVID-19 pneumonia confirmed with polymerase chain reaction (PCR).
- Acute respiratory failure.
- Treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP or noninvasive ventilation), initiated outside the intensive care unit.
- Age > 18 years
Who cannot join
- Acute respiratory failure not related to COVID-19
- Hypercapnic acute respiratory failure
- Early intolerance to treatment
- Nosocomial infection
- Pregnant woman
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar, Parc de Salut Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Dr.Josep Trueta
Girona, 17007
Hospital General de Granollers
Granollers, Barcelona, 08402
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Fundació Althaia
Manresa, Barcelona, 08243
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitari Mútua Terrassa
Terrassa, Bardelona, 08221
About this study
Official title: Noninvasive Respiratory Support Outside the Intensive Care Unit in COVID-19 Pneumonia: a Multicentric Study (CATCOVID-AIR)
COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.
Read the detailed description
Multicenter, retrospective, longitudinal study in consecutive adult COVID-19 patients with acute respiratory failure, requiring noninvasive respiratory support (NIRS) outside the intensive care unit (ICU) in 10 hospitals in Catalonia (Spain). Demographic, laboratory, clinical and noninvasive respiratory support data will be collected and analyzed according to the primary outcome (death or endotracheal intubation at day 28) and secondary outcomes (see the dedicated section).
During the hospitalization, patients were treated according to the standard procedures of the participating centers. This study is observational and no randomization have been performed.
Patients were followed up to either 28-days or hospital discharge if still hospitalized at day 28 from NIRS initiation.
- Conditions
- Covid19, Acute Respiratory Failure, Corona Virus Infection
- Being tested
- High-flow nasal cannula treatment, Continuous positive airway pressure (CPAP) treatment, Noninvasive ventilation treatment
- Keywords
- Noninvasive ventilation, High-flow nasal cannula, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Tract Diseases, Coronavirus Infection
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome, Respiratory Insufficiency, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula treatmentDevice
Standard operating procedures represented by hihg-flow nasal cannula oxygen therapy
Continuous positive airway pressure (CPAP) treatmentDevice
Standard operating procedures represented by continuous positive airway pressure (CPAP) therapy
Noninvasive ventilation treatmentDevice
Standard operating procedures represented by noninvasive ventilation treatment
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal cannula treatment | Not described Receives: Device: High-flow nasal cannula treatment | |
| Continuous positive airway pressure (CPAP) treatment | Not described Receives: Device: Continuous positive airway pressure (CPAP) treatment | |
| Noninvasive ventilation treatment | Not described Receives: Device: Noninvasive ventilation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Death or endotracheal intubation
Measured: 28 days within noninvasive respiratory support initiation
Secondary outcomes (4)
28-day mortality
Measured: 28 days within noninvasive respiratory support initiation
Hospital mortality
Any death during hospital stay
Measured: Until 28 days from noninvasive respiratory support initiation
Endotracheal intubation
Measured: 28 days within noninvasive respiratory support initiation
Duration of hospital stay
Time between admission and discharge from hospital or death in hospital
Measured: Until 28 days from noninvasive respiratory support initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start22 May 2020
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
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 Covid19Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- 367 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Barcelona Institute for Global Health
- Responsible party
- Sponsor
- Investigators
- Júlia Sampol, MD, Study chair, Hospital Universitari Vall d'Hebron Research InstituteSergi Marti, MD PhD, Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668196
- Sponsor's protocol ID
- PR(AG)265/2020
- Acronym
- CATCOVID-AIR
- Status last verified
- Apr 2021
- First submitted
- 11 Dec 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marti S, Carsin AE, Sampol J, Pallero M, Aldas I, Marin T, Lujan M, Lalmolda C, Sabater G, Bonnin-Vilaplana M, Penacoba P, Martinez-Llorens J, Tarrega J, Bernadich O, Cordoba-Izquierdo A, Lozano L, Mendez S, Velez-Segovia E, Prina E, Eizaguirre S, Balana-Corbero A, Ferrer J, Garcia-Aymerich J. Higher mortality and intubation rate in COVID-19 patients treated with noninvasive ventilation compared with high-flow oxygen or CPAP. Sci Rep. 2022 Apr 20;12(1):6527. doi: 10.1038/s41598-022-10475-7.
PubMed 35444251
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Respiratory Support Outside the Intensive Care Unit in COVID-19 Pneumonia: a Multicentric Study (CATCOVID-AIR)
- ClinicalTrials.gov ID
- NCT04668196
- Acronym / sponsor ID
- CATCOVID-AIR / PR(AG)265/2020
- Conditions
- Covid19, Acute Respiratory Failure, Corona Virus Infection
- Keywords
- Noninvasive ventilation, High-flow nasal cannula, Severe Acute Respiratory Syndrome, Respiratory Failure, Respiratory Tract Diseases, Coronavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Barcelona Institute for Global Health
- Study start
- 22 May 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 16 Dec 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.
COVID-19 pneumonia can cause severe acute hypoxemic respiratory failure. The usefulness of noninvasive respiratory support (NIRS), by means of nasal high-flow oxygen (NHFO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV), established outside the intensive care unit, is unknown. The aim of this multicenter, retrospective, longitudinal study is to compare the effectiveness of these treatments to prevent death or endotracheal intubation at day 28, and what factors, related to the disease or to the characteristics of the treatment itself, can condition its success or failure.
Detailed description
Multicenter, retrospective, longitudinal study in consecutive adult COVID-19 patients with acute respiratory failure, requiring noninvasive respiratory support (NIRS) outside the intensive care unit (ICU) in 10 hospitals in Catalonia (Spain). Demographic, laboratory, clinical and noninvasive respiratory support data will be collected and analyzed according to the primary outcome (death or endotracheal intubation at day 28) and secondary outcomes (see the dedicated section).
During the hospitalization, patients were treated according to the standard procedures of the participating centers. This study is observational and no randomization have been performed.
Patients were followed up to either 28-days or hospital discharge if still hospitalized at day 28 from NIRS initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula treatment | – | Device: High-flow nasal cannula treatment |
| Continuous positive airway pressure (CPAP) treatment | – | Device: Continuous positive airway pressure (CPAP) treatment |
| Noninvasive ventilation treatment | – | Device: Noninvasive ventilation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID19 patients treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP, or noninvasive ventilation), initiated outside the intensive care unit.
Key inclusion criteria (4 listed)
- COVID-19 pneumonia confirmed with polymerase chain reaction (PCR).
- Acute respiratory failure.
- Treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP or noninvasive ventilation), initiated outside the intensive care unit.
- Age > 18 years
Key exclusion criteria (5 listed)
- Acute respiratory failure not related to COVID-19
- Hypercapnic acute respiratory failure
- Early intolerance to treatment
- Nosocomial infection
- Pregnant woman
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 |
|---|---|---|
| High-flow nasal cannula treatmentStandard operating procedures represented by hihg-flow nasal cannula oxygen therapy | Device | High-flow nasal cannula treatment |
| Continuous positive airway pressure (CPAP) treatmentStandard operating procedures represented by continuous positive airway pressure (CPAP) therapy | Device | Continuous positive airway pressure (CPAP) treatment |
| Noninvasive ventilation treatmentStandard operating procedures represented by noninvasive ventilation treatment | Device | Noninvasive ventilation treatment |
Primary outcome
Treatment failure
Time frame: 28 days within noninvasive respiratory support initiation
Death or endotracheal intubation
4 secondary outcomes
28-day mortality
Time frame: 28 days within noninvasive respiratory support initiation
Hospital mortality
Time frame: Until 28 days from noninvasive respiratory support initiation
Endotracheal intubation
Time frame: 28 days within noninvasive respiratory support initiation
Duration of hospital stay
Time frame: Until 28 days from noninvasive respiratory support initiation
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 13 Apr 2021.
- Derived from this study: PubMed 35444251Marti S, Carsin AE, Sampol J, Pallero M, Aldas I, Marin T, Lujan M, Lalmolda C, Sabater G, Bonnin-Vilaplana M, Penacoba P, Martinez-Llorens J, Tarrega J, Bernadich O, Cordoba-Izquierdo A, Lozano L, Mendez S, Velez-Segovia E, Prina E, Eizaguirre S, Balana-Corbero A, Ferrer J, Garcia-Aymerich J. Higher mortality and intubation rate in COVID-19 patients treated with noninvasive ventilation compared with high-flow oxygen or CPAP. Sci Rep. 2022 Apr 20;12(1):6527. doi: 10.1038/s41598-022-10475-7.
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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.
Júlia Sampol, MD study chair
Hospital Universitari Vall d'Hebron Research Institute
Sergi Marti, MD PhD principal investigator
Hospital Universitari Vall d'Hebron Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Acute Respiratory Failure, run by Hospital Universitari Vall d'Hebron Research Institute at 10 sites in Spain.
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 4 inclusion and 5 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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?
Treatment failure (time frame: 28 days within noninvasive respiratory support initiation). 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 NCT04668196, 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 13 Apr 2021.