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

March 26, 2022 updated by: Hamad Medical Corporation

Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Doha, Qatar
        • Hamad medical corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled Iloprost therapy
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
Other Names:
  • Ventavis by Actelion Pharmaceuticals US, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nadir Kharma, MD, Hamad medical corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 26, 2022

Last Verified

May 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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