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NCT Number: NCT04445246

Inhaled Iloprost for Suspected COVID-19 Respiratory Failure

Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs. ARDS is thought to be the main cause of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for treatment and support of COVID-19 patients with respiratory failure.

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Key information

Conditions

COVID-19 ARDS, Human Coronaviridae Infections Coronavirus Infections Hypoxemic Respiratory Failure Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamad Medical Corporation

Doha, Qatar

About this study

The investigators hypothesize that inhaled prostacyclins (Iloprost in this study) may improve inflammation and oxygenation in suspected or confirmed COVID-19 patients with respiratory failure.

Research participants: Suspected or confirmed COVID-19 patients presenting to the emergency department (ED) of intensive care units (ICU) with Hypoxemic respiratory failure.

Intervention: Inhaled Iloprost (Tradename Ventavis by Actelion Pharmaceuticals US, Inc.) three times daily for 5 days Methods: patients will be screened in ED and ICU for inclusion and exclusion criteria and then consent will be obtained. The intervention will be started within 48 hours of presentation. Baseline parameters on oxygenation, inflammatory markers, hemodynamics will be obtained and followed serially over the period of the intervention. Additional data about time to intubation, time on mechanical ventilation, lung mechanics, and need for prone positioning will also be collected.

Data will be analyzed for percentage improvement in oxygenation (Oxygen saturation and PaO2/FiO2 ratio), trends of inflammatory markers, and hemodynamic stability while Iloprost is administered.

Based on previous studies of Iloprost on ARDS patients, the investigators anticipate an improvement in oxygenation and inflammatory parameters and possible prevention of intubation with shorter mechanical ventilation times. Iloprost showed a safe profile with stable hemodynamics during administration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Suspected or confirmed COVID-19 patient by PCR
  • O2 saturation =<92% on 5 or more l/min of O2 by NC or Face mask
  • On CPAP, HFNC or Invasive ventilation
  • Enrollment within 48h of onset of hypoxemia

Exclusion criteria

  • Age <18
  • Pregnancy or Positive pregnancy test at the time of screening
  • Clinical evidence of left atrial hypertension or known chronic CHF
  • Persistent Hypotension SBP<85 on presentation
  • Mechanical ventilation >7 days
  • Patients who received iloprost treatment for any indication within 48 hours prior to enrollment in the clinical trial or patients who were on thrombin inhibitors, or nitric oxide within the previous 24 h before study randomization are also excluded.
  • Patients with contraindication for ilioprost

Treatment and study plan

Inhaled ILOPROST

Drug

Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.

Other names: Ventavis by Actelion Pharmaceuticals US, Inc.

Primary outcomes

  1. change in oxygenation parameters

    Time frame: 5 days

    change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation.

Secondary outcomes

  1. Rates of endotracheal intubation

    Time frame: 28 days

    likelihood to require intubation in the cohort treated with Iloprost

  2. Invasive ventilation duration

    Time frame: 28 days

    in days in the cohort treated with Iloprost

  3. ICU length of stay

    Time frame: 28 days

    in days in the cohort treated with Iloprost

  4. Hospital Length of stay

    Time frame: 28 days

    in days in the cohort treated with Iloprost

  5. Rates of proning therapy

    Time frame: 28 days

    likelihood to require proning in the cohort treated with Iloprost

  6. Rates of ECMO cannulation

    Time frame: 28 days

    likelihood to require ECMO cannulation in the cohort treated with Iloprost

  7. Mortality

    Time frame: 28 days

    likelihood to die of any cause within 28 days of initial hospital presentation

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure

Acronym: ILOCOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2020
Registry last updated
Mar 29, 2022

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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