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Completed

NCT Number: NCT05216575

Almitrine in COVID-19 Patients With ARDS Treated by HFNO

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.

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Key information

Conditions

ARDS Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE

Nice, 06200, France

About this study

From December 2019, the emergent coronavirus SARSCoV-2 is responsible for the worldwide pandemic of coronavirus disease (COVID-19). Although SARSCoV-2 infection is mainly responsible for mild respiratory symptoms, up to 70% of hospitalized patients with COVID-19-related pneumoniae may develop severe respiratory disease, progressing to acute respiratory distress syndrome (ARDS). These patients may experience severe but well-tolerated hypoxemia, so-called "happy hypoxemia" which may be related to blunted hypoxic vasoconstriction. Almitrine is a selective pulmonary vasoconstrictor that has been reported to improve the oxygenation in ARDS patients by increasing hypoxic pulmonary vasoconstriction. Some small case series reported that the use of Almitrine in mechanically ventilated COVID-19 patients with ARDS improved oxygenation. Given the "happy hypoxemia" phenomenon, it has been suggested to use high-flow nasal canula therapy (HFNO) as first-line ventilatory support in COVID-19 patients with ARDS, since the risk of aerosolization with HFNO was similar to that with standard oxygen therapy and lower to that with non-invasive ventilation. However, the effects of Almitrine in spontaneously breathing patients with ARDS has not been reported so far. Thus, the main goal of this study is to investigate the effects of Almitrine on oxygenation of COVID-19 patients with ARDS treated by HFNO as first-line ventilatory support. The second goal of this study is to determine the effects of Almitrine on respiratory mechanics and hymodynamics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Almitrine-induced increase in Pa02/FiO2 ratio.

    Time frame: The 30-minute duration of Almitrine bolus

    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.

Secondary outcomes

  1. Proportion of patients requiring intubation

    Time frame: ICU stay

    To assess the proportion of patients who will require to be intubated during their ICU stay.

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

    Time frame: The 30-minute duration of Almitrine bolus

    To assess the proportion of patients who will experience right ventricular failure and/or right ventricular dilation and/or acute core pulmonale after administration of Almitrine.

  3. Clinical prediction of Almitrine effects

    Time frame: The 30-minute duration of Almitrine bolus

    To test the ability of different respiratory variables and radiological patterns to predict the response to Almitrine in terms of oxygenation

  4. Radiological prediction of Almitrine effects

    Time frame: The 30-minute duration of Almitrine bolus

    To test the ability of different radiological patterns to predict the response to Almitrine in terms of oxygenation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Use of Almitrine in COVID-19 Patients With Acute Respiratory Distress Syndrome Treated by High-flow Nasal Canula Oxygen Therapy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2022
Registry last updated
Apr 24, 2025

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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