Inhaled Iloprost for Suspected COVID-19 Respiratory Failure (ILOCOVID)
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|ClinicalTrials.gov Identifier: NCT04445246|
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 ARDS, Human Hypoxemic Respiratory Failure||Drug: Inhaled ILOPROST||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure|
|Actual Study Start Date :||May 23, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Inhaled Iloprost therapy
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization
Drug: Inhaled ILOPROST
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
Other Name: Ventavis by Actelion Pharmaceuticals US, Inc.
- 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.
- Rates of endotracheal intubation [ Time Frame: 28 days ]likelihood to require intubation in the cohort treated with Iloprost
- Invasive ventilation duration [ Time Frame: 28 days ]in days in the cohort treated with Iloprost
- ICU length of stay [ Time Frame: 28 days ]in days in the cohort treated with Iloprost
- Hospital Length of stay [ Time Frame: 28 days ]in days in the cohort treated with Iloprost
- Rates of proning therapy [ Time Frame: 28 days ]likelihood to require proning in the cohort treated with Iloprost
- Rates of ECMO cannulation [ Time Frame: 28 days ]likelihood to require ECMO cannulation in the cohort treated with Iloprost
- Mortality [ Time Frame: 28 days ]likelihood to die of any cause within 28 days of initial hospital presentation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445246
|Contact: Nadir Kharma, MDemail@example.com|
|Contact: Ali AitHssain, MD||+97444396298||AHssain@hamad.qa|
|Hamad Medical Corporation||Recruiting|
|Contact: Nadir Kharma, MD +97444396298 firstname.lastname@example.org|
|Principal Investigator:||Nadir Kharma, MD||Hamad Medical Corporation|