Inhaled Iloprost for Suspected COVID-19 Respiratory Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COVID-19, ARDS, Human, Hypoxemic Respiratory Failure

Intervention / Treatment
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* Drug: Inhaled ILOPROST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled Iloprost therapy<br>Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization | Drug: Inhaled ILOPROST<br>* Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.<br>* Other names: Ventavis by Actelion Pharmaceuticals US, Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in oxygenation parameters | change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of endotracheal intubation | likelihood to require intubation in the cohort treated with Iloprost | 28 days | 
| Invasive ventilation duration | in days in the cohort treated with Iloprost | 28 days | 
| ICU length of stay | in days in the cohort treated with Iloprost | 28 days | 
| Hospital Length of stay | in days in the cohort treated with Iloprost | 28 days | 
| Rates of proning therapy | likelihood to require proning in the cohort treated with Iloprost | 28 days | 
| Rates of ECMO cannulation | likelihood to require ECMO cannulation in the cohort treated with Iloprost | 28 days | 
| Mortality | likelihood to die of any cause within 28 days of initial hospital presentation | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iloprost, prostacyclins, inhaled nitric oxide, pulmonary vasodilators