ILOCOVID: Inhaled Iloprost for Suspected COVID-19 Respiratory Failure

Sponsor
Hamad Medical Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04445246
Collaborator
(none)
40
1
1
12.3
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Inhaled ILOPROST
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure
Actual Study Start Date :
May 23, 2020
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Ventavis by Actelion Pharmaceuticals US, Inc.
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Rates of endotracheal intubation [28 days]

      likelihood to require intubation in the cohort treated with Iloprost

    2. Invasive ventilation duration [28 days]

      in days in the cohort treated with Iloprost

    3. ICU length of stay [28 days]

      in days in the cohort treated with Iloprost

    4. Hospital Length of stay [28 days]

      in days in the cohort treated with Iloprost

    5. Rates of proning therapy [28 days]

      likelihood to require proning in the cohort treated with Iloprost

    6. Rates of ECMO cannulation [28 days]

      likelihood to require ECMO cannulation in the cohort treated with Iloprost

    7. Mortality [28 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamad Medical Corporation Doha Qatar

    Sponsors and Collaborators

    • Hamad Medical Corporation

    Investigators

    • Principal Investigator: Nadir Kharma, MD, Hamad Medical Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hamad Medical Corporation
    ClinicalTrials.gov Identifier:
    NCT04445246
    Other Study ID Numbers:
    • MRC-05-026
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Hamad Medical Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022