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

Covid19 Clinical Trial

— CATCOVID-AIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04668196
• Other study ID #: PR(AG)265/2020
• Status: Completed
• Start date: May 22, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: April 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Corona Virus Infection
• Coronavirus Infections
• Covid19
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome

Intervention

Device:
• High-flow nasal cannula treatment
Standard operating procedures represented by hihg-flow nasal cannula oxygen therapy
• Continuous positive airway pressure (CPAP) treatment
Standard operating procedures represented by continuous positive airway pressure (CPAP) therapy
• Noninvasive ventilation treatment
Standard operating procedures represented by noninvasive ventilation treatment

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar, Parc de Salut Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Dr.Josep Trueta	Girona
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Fundació Althaia	Manresa	Barcelona
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital Universitari Mútua Terrassa	Terrassa	Bardelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Barcelona Institute for Global Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	Death or endotracheal intubation	28 days within noninvasive respiratory support initiation
Secondary	28-day mortality		28 days within noninvasive respiratory support initiation
Secondary	Hospital mortality	Any death during hospital stay	Until 28 days from noninvasive respiratory support initiation
Secondary	Endotracheal intubation		28 days within noninvasive respiratory support initiation
Secondary	Duration of hospital stay	Time between admission and discharge from hospital or death in hospital	Until 28 days from noninvasive respiratory support initiation