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

Primary Purpose

COVID-19, ARDS, Human, Hypoxemic Respiratory Failure

Status
Completed
Phase
Phase 2
Locations
Qatar
Study Type
Interventional
Intervention
Inhaled ILOPROST
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Iloprost, prostacyclins, inhaled nitric oxide, pulmonary vasodilators

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamad Medical Corporation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhaled Iloprost therapy

Arm Description

Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2020
Last Updated
March 26, 2022
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04445246
Brief Title
Inhaled Iloprost for Suspected COVID-19 Respiratory Failure
Acronym
ILOCOVID
Official Title
Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, ARDS, Human, Hypoxemic Respiratory Failure
Keywords
Iloprost, prostacyclins, inhaled nitric oxide, pulmonary vasodilators

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Iloprost therapy
Arm Type
Experimental
Arm Description
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization
Intervention Type
Drug
Intervention Name(s)
Inhaled ILOPROST
Other Intervention Name(s)
Ventavis by Actelion Pharmaceuticals US, Inc.
Intervention Description
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
Primary Outcome Measure Information:
Title
change in oxygenation parameters
Description
change in oxygen saturation and PaO2/FiO2 ratio by 20% on day 6 compared to baseline values prior to Iloprost initiation.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Rates of endotracheal intubation
Description
likelihood to require intubation in the cohort treated with Iloprost
Time Frame
28 days
Title
Invasive ventilation duration
Description
in days in the cohort treated with Iloprost
Time Frame
28 days
Title
ICU length of stay
Description
in days in the cohort treated with Iloprost
Time Frame
28 days
Title
Hospital Length of stay
Description
in days in the cohort treated with Iloprost
Time Frame
28 days
Title
Rates of proning therapy
Description
likelihood to require proning in the cohort treated with Iloprost
Time Frame
28 days
Title
Rates of ECMO cannulation
Description
likelihood to require ECMO cannulation in the cohort treated with Iloprost
Time Frame
28 days
Title
Mortality
Description
likelihood to die of any cause within 28 days of initial hospital presentation
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected or confirmed COVID-19 patient by PCR O2 saturation =<92% on 5 or more l/min of O2 by NC or Face mask On CPAP, HFNC or Invasive ventilation Enrollment within 48h of onset of hypoxemia Exclusion Criteria: Age <18 Pregnancy or Positive pregnancy test at the time of screening Clinical evidence of left atrial hypertension or known chronic CHF Persistent Hypotension SBP<85 on presentation Mechanical ventilation >7 days 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. Patients with contraindication for ilioprost
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadir Kharma, MD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
Country
Qatar

12. IPD Sharing Statement

Citations:
PubMed Identifier
34529182
Citation
Mulia EPB, Luke K. Inhaled prostacyclin analogues in COVID-19 associated acute respiratory distress syndrome: scientific rationale. Egypt Heart J. 2021 Sep 16;73(1):82. doi: 10.1186/s43044-021-00208-y.
Results Reference
derived

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Inhaled Iloprost for Suspected COVID-19 Respiratory Failure

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