ARDS, Human, COVID-19, Hypoxemic Respiratory Failure
Conditions
Keywords
Iloprost, prostacyclins, inhaled nitric oxide, pulmonary vasodilators
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.
Interventions
DRUGInhaled ILOPROST
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
Sponsors
Hamad Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Hospital 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 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 |
| Rates of proning therapy | 28 days | likelihood to require proning in the cohort treated with Iloprost |
Countries
Qatar
Outcome results
None listed