High-Flow Nasal Cannula in Severe COVID-19 With Acute Hypoxemic Respiratory Failure.

NCT04609462 | Completed DMC

• 1 other identifier: 001635
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

This open label randomized controlled multicenter phase II trial will evaluate the clinical impact of the use of HFNC vs. conventional oxygen therapy in patients with moderate and severe hypoxemic acute respiratory failure secondary to SARS-CoV-2 infection.

Conditions

Acute Hypoxemic Respiratory Failure; Covid19

Keywords

Acute Hypoxemic Respiratory Failure; SARS-CoV-2 infection; High flow nasal cannula; Conventional oxygen therapy; Oxygen therapy

Outcome Measures

Primary Outcomes (2)

• Intubation rate

  Need for intubation / support with invasive mechanical ventilation.

  28 days

• Clinical recovery

  Time to improvement of clinical status according to the 7-point ordinal scale. Modified 7-point ordinal scale: * An ordinal scale of 7 points where 1= Ambulatory/no limitation of activities and 7= Death. Low scores denote a better outcome and high scores denote a worse outcome. * Time to reduction in scale score will be measured (daily scale scoring).

  28 days

Secondary Outcomes (8)

• Proportion of patients with requirement of early mechanical ventilation.

  7 and 14 days

• Mechanical ventilation-free days

  28 days

• Renal replacement therapy-free days

  28 days

• Length of ICU stay

  28 days

• Length of hospital stay

  28 days

Study Arms (2)

Conventional oxygen therapy (COT) group

ACTIVE COMPARATOR

Oxygen therapy will be delivered by conventional nasal cannula / prongs, venturi mask, or mask with reservoir, with flows between 3 and 15 liters / minute, to ensure SpO2 ≥ 92%.

Procedure: Conventional oxygen therapy

High-flow nasal cannula (HFNC) group

EXPERIMENTAL

Breathing support with High-Flow oxygen therapy, flow will be initiated between 50 and 60 liters / minute. FiO2 60% to 100% with the objective of reaching SpO2 ≥ 92%. Adequate wetting of the system should be ensured according to the recommendations of the HFNC device manufacturer. FiO2 may be decreased gradually according to the patient's individual condition, trying to maintain SpO2 ≥ 92%.

Procedure: High flow nasal cannula

Interventions

Conventional oxygen therapy PROCEDURE

Oxygen therapy by conventional nasal cannula / prongs, venturi mask, or mask with reservoir

Conventional oxygen therapy (COT) group

High flow nasal cannula PROCEDURE

Breathing support with High-flow nasal cannula

High-flow nasal cannula (HFNC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \> 18 years.
• Emergency or ICU admission with suspected/confirmed SARS-CoV-2 infection.
• Moderate/severe acute respiratory failure:
• PaO2/FiO2 \< 200.
• Use of accessory muscles.
• Breathing rate \> 25 x minute.
• Have a progression \< 6 hours since meeting the definition of moderate/severe acute respiratory failure secondary to suspected/confirmed SARS-CoV-2 infection.

You may not qualify if:

• Adults \< 18 years.
• Indication for immediate orotracheal intubation.
• Chronic liver disease / liver cirrhosis Child-Pugh C.
• Confirmation of active bacterial or fungal infection.
• Uncontrolled HIV/AIDS disease (defined by presence of viral load \> 200 copies/mL).
• Previous history of COPD Gold C - D.
• History of COPD requiring hospitalization - hospitalization / ICU in the last year.
• Known history of congestive heart failure NYHA III - IV.
• Left ventricular ejection fraction \< 45% previously known.
• Highly suspected or confirmed cardiogenic pulmonary edema.
• Hypercapnic respiratory failure (PaCO2 \> 55 mmHg).
• Central/peripheral demyelinating disorders due to medical history or high suspicion of these at the time of study eligibility.
• Patient who in the investigator's judgment suggests a progression to death is imminent and inevitable within the next 24 hours.
• Any serious medical condition or clinical laboratory test abnormality that, in the investigator's judgment, prevents safe patient participation and completion of the study.
• Participation in another clinical trial (except one related to SARS-CoV-2 - CRITERIA TO BE DISCUSSED BETWEEN GROUP OF RESEARCHES).

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, 76032, Colombia

Location

Related Publications (1)

• Ospina-Tascon GA, Calderon-Tapia LE, Garcia AF, Zarama V, Gomez-Alvarez F, Alvarez-Saa T, Pardo-Otalvaro S, Bautista-Rincon DF, Vargas MP, Aldana-Diaz JL, Marulanda A, Gutierrez A, Varon J, Gomez M, Ochoa ME, Escobar E, Umana M, Diez J, Tobon GJ, Albornoz LL, Celemin Florez CA, Ruiz GO, Caceres EL, Reyes LF, Damiani LP, Cavalcanti AB; HiFLo-Covid Investigators. Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2161-2171. doi: 10.1001/jama.2021.20714.

  PMID: 34874419 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Gustavo A. Ospina Tascón, MDPhD

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II, multicenter, randomized, open-label, controlled study of the use of high flow nasal cannula respiratory support vs. conventional oxygen therapy in patients with moderate/severe hypoxemic respiratory failure secondary to SARS-CoV-2 infection.

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 30, 2020
• Study Start: August 11, 2020
• Primary Completion: January 13, 2021
• Study Completion: February 10, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CO (1)