Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inhaled Iloprost for Suspected COVID-19 Respiratory Failure (ILOCOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445246
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 ARDS, Human Hypoxemic Respiratory Failure 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021


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 Name: Ventavis by Actelion Pharmaceuticals US, Inc.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rates of endotracheal intubation [ Time Frame: 28 days ]
    likelihood to require intubation in the cohort treated with Iloprost

  2. Invasive ventilation duration [ Time Frame: 28 days ]
    in days in the cohort treated with Iloprost

  3. ICU length of stay [ Time Frame: 28 days ]
    in days in the cohort treated with Iloprost

  4. Hospital Length of stay [ Time Frame: 28 days ]
    in days in the cohort treated with Iloprost

  5. Rates of proning therapy [ Time Frame: 28 days ]
    likelihood to require proning in the cohort treated with Iloprost

  6. Rates of ECMO cannulation [ Time Frame: 28 days ]
    likelihood to require ECMO cannulation in the cohort treated with Iloprost

  7. Mortality [ Time Frame: 28 days ]
    likelihood to die of any cause within 28 days of initial hospital presentation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Nadir Kharma, MD +97444396298 nkharma@hamad.qa
Contact: Ali AitHssain, MD +97444396298 AHssain@hamad.qa

Locations
Layout table for location information
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Contact: Nadir Kharma, MD    +97444396298    nkharma@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Layout table for investigator information
Principal Investigator: Nadir Kharma, MD Hamad Medical Corporation
Layout table for additonal information
Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04445246    
Other Study ID Numbers: MRC-05-026
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: May 2020

Layout table for additional information
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:
Iloprost
prostacyclins
inhaled nitric oxide
pulmonary vasodilators
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents