Almitrine in COVID-19 Patients With ARDS Treated by HFNO

NCT05216575 | Completed

• 1 other identifier: 22reamedcovid01
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of Almitrine administration on oxygenation in COVID-19 patients with acute respiratory distress syndrome treated by high-flow nasal canula oxygen therapy as first-line ventilatory support.

Conditions

ARDS; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Almitrine-induced increase in Pa02/FiO2 ratio.

  The PaO2/FiO2 ratio will be calculated before and after the bolus of Almitrine. Patients with increase in PaO2/FiO2 ratio \> 20% will be considered as responders.

  The 30-minute duration of Almitrine bolus

Secondary Outcomes (4)

• Proportion of patients requiring intubation

  ICU stay

• Proportion of patients exhibiting right ventricular failure and/or right ventricular dilation and/or acute core pulmonale after administration of Almitrine.

  The 30-minute duration of Almitrine bolus

• Clinical prediction of Almitrine effects

  The 30-minute duration of Almitrine bolus

• Radiological prediction of Almitrine effects

  The 30-minute duration of Almitrine bolus

Study Arms (1)

Almitrine treated patients

Administration of Almitrine in spontaneoulsy breathing COVID-19 patients with moderate to severe ARDS treated by high-flow nasal canula oxygen therapy as first-line ventilatory support with persitent severe hypoxemia after awake prone positioning.

Drug: Administration of Almitrine

Interventions

Administration of Almitrine DRUG

Administration of Almitrine (intravenous bolus of 0.5 mg/kg over 30 minutes followed by a continuous perfusion of 16 mg/kg/min in responders)

Almitrine treated patients

Eligibility Criteria

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

Study Population

Eligible patients are spontaneously breathing COVID-19 patients with moderate to severe ARDS treated by high-flow nasal canula oxygen therapy as first-line ventilatory support with persitent severe hypoxemia after awake prone positioning.

You may qualify if:

• Patients treated by high-flow nasal canula oxygen
• Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs
• Persistent severe hypoxemia after awake prone positioning defined by one or more of the following criteria:
• SpO2 \< 96% with FiO2 \> 80%
• PaO2/FiO2 ratio \< 100 with FiO2 \> 80%
• Patients treated by Almitrine

You may not qualify if:

• Age \<18 years old and pregnant women
• Patients under legal protection
• Patients with a do not intubate or do not resuscitate decision
• Patients requiring immediate invasive mechanical ventilation
• Contraindication to Almitrine
• Poor echogenicity

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06200, France

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: January 31, 2022
• Study Start: January 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)