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CompletedNCT04668196CATCOVID-AIRUpdated Apr 13, 2021

Noninvasive Respiratory Support in COVID-19 (CATCOVID-AIR)

An observational study in Covid19, Acute Respiratory Failure and Corona Virus Infection, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-13.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
367
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • 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
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In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 367 is above the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COVID19 patients treated by noninvasive respiratory support (nasal high-flow oxygen, CPAP, or noninvasive ventilation), initiated outside the intensive care unit.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Acute respiratory failure not related to COVID-19
  • Hypercapnic acute respiratory failure
  • Early intolerance to treatment
  • Nosocomial infection
  • Pregnant woman
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
367 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceHigh-flow nasal cannula treatment

    Standard operating procedures represented by hihg-flow nasal cannula oxygen therapy

  • DeviceContinuous positive airway pressure (CPAP) treatment

    Standard operating procedures represented by continuous positive airway pressure (CPAP) therapy

  • DeviceNoninvasive ventilation treatment

    Standard operating procedures represented by noninvasive ventilation treatment

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What researchers measure

Primary outcomes

  1. Treatment failure

    Death or endotracheal intubation

    Time frame: 28 days within noninvasive respiratory support initiation

Secondary outcomes

  1. 28-day mortality

    Time frame: 28 days within noninvasive respiratory support initiation

  2. Hospital mortality

    Any death during hospital stay

    Time frame: Until 28 days from noninvasive respiratory support initiation

  3. Endotracheal intubation

    Time frame: 28 days within noninvasive respiratory support initiation

  4. Duration of hospital stay

    Time between admission and discharge from hospital or death in hospital

    Time frame: Until 28 days from noninvasive respiratory support initiation

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Study locations

10 sites
  • Hospital Germans Trias i Pujol
    Badalona, Barcelona 08916, Spain
  • Hospital General de Granollers
    Granollers, Barcelona 08402, Spain
  • Hospital de Bellvitge
    Hospitalet de Llobregat, Barcelona, Spain
  • Fundació Althaia
    Manresa, Barcelona 08243, Spain
  • Corporació Sanitària Parc Taulí
    Sabadell, Barcelona 08208, Spain
  • Hospital Universitari Mútua Terrassa
    Terrassa, Bardelona 08221, Spain
  • Hospital del Mar, Parc de Salut Mar
    Barcelona, 08003, Spain
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
  • Hospital Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Dr.Josep Trueta
    Girona, 17007, Spain
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04668196
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Barcelona Institute for Global Health
Responsible party
Sponsor
First posted
Dec 16, 2020
Start date
May 22, 2020
Primary completion
Jan 25, 2021
Completion
Jan 25, 2021
Last update
Apr 13, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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