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NCT Number: NCT04668196

Noninvasive Respiratory Support in COVID-19 (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.

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Key information

Conditions

Covid19 Acute Respiratory Failure COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

High-flow nasal cannula treatment

Device

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

Continuous Positive Airway Pressure (CPAP) Treatment

Device

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

Noninvasive ventilation treatment

Device

Standard operating procedures represented by noninvasive ventilation treatment

Primary outcomes

  1. Treatment failure

    Time frame: 28 days within noninvasive respiratory support initiation

    Death or endotracheal intubation

Secondary outcomes

  1. 28-day mortality

    Time frame: 28 days within noninvasive respiratory support initiation

  2. Hospital mortality

    Time frame: Until 28 days from noninvasive respiratory support initiation

    Any death during hospital stay

  3. Endotracheal intubation

    Time frame: 28 days within noninvasive respiratory support initiation

  4. Duration of hospital stay

    Time frame: Until 28 days from noninvasive respiratory support initiation

    Time between admission and discharge from hospital or death in hospital

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Barcelona Institute for Global Health

Registry information

Official study title

Noninvasive Respiratory Support Outside the Intensive Care Unit in COVID-19 Pneumonia: a Multicentric Study (CATCOVID-AIR)

Acronym: CATCOVID-AIR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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