Inhaled Iloprost for Suspected COVID-19 Respiratory Failure

Phase 2

Completed

• Conditions: ARDS, Human; Hypoxemic Respiratory Failure; COVID-19
• Interventions: Drug: Inhaled ILOPROST

• Registration Number: NCT04445246
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-23
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-24
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

1. Age <18
2. Pregnancy or Positive pregnancy test at the time of screening
3. Clinical evidence of left atrial hypertension or known chronic CHF
4. Persistent Hypotension SBP<85 on presentation
5. Mechanical ventilation >7 days
6. 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.
7. Patients with contraindication for ilioprost

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inhaled Iloprost therapy	Inhaled ILOPROST	Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization

Primary Outcome Measures

Name	Time	Method
change in oxygenation parameters	5 days	change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar