COVID-19Phase 2ILOCOVIDNCT04445246
Inhaled Iloprost for Suspected COVID-19 Respiratory Failure
A Phase 2 study testing Inhaled ILOPROST in people with COVID-19 and ARDS, Human, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, ARDS, Human, Hypoxemic Respiratory Failure
- What is being tested?
- Inhaled ILOPROST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteQatar
- Study dates
- 23 May 2020to 31 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, ARDS, Human, Hypoxemic Respiratory Failure
- Being tested
- Inhaled ILOPROST
- Keywords
- Iloprost, prostacyclins, inhaled nitric oxide, pulmonary vasodilators
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled ILOPROSTDrug
Also called Ventavis by Actelion Pharmaceuticals US, Inc.
Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Iloprost therapy | Experimental | Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization Receives: Drug: Inhaled ILOPROST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (7)
Rates of endotracheal intubation
likelihood to require intubation in the cohort treated with Iloprost
Measured: 28 days
Invasive ventilation duration
in days in the cohort treated with Iloprost
Measured: 28 days
ICU length of stay
in days in the cohort treated with Iloprost
Measured: 28 days
Hospital Length of stay
in days in the cohort treated with Iloprost
Measured: 28 days
Rates of proning therapy
likelihood to require proning in the cohort treated with Iloprost
Measured: 28 days
Rates of ECMO cannulation
likelihood to require ECMO cannulation in the cohort treated with Iloprost
Measured: 28 days
Mortality
likelihood to die of any cause within 28 days of initial hospital presentation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start23 May 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadir Kharma, MD, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445246
- Sponsor's protocol ID
- MRC-05-026
- Acronym
- ILOCOVID
- Status last verified
- May 2020
- First submitted
- 9 Jun 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34529182
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure
- ClinicalTrials.gov ID
- NCT04445246
- Acronym / sponsor ID
- ILOCOVID / MRC-05-026
- Conditions
- COVID-19, ARDS, Human, Hypoxemic Respiratory Failure
- Keywords
- Iloprost, prostacyclins, inhaled nitric oxide, pulmonary vasodilators
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 May 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled Iloprost therapy | Experimental | Drug: Inhaled ILOPROSTInhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled ILOPROSTAlso: Ventavis by Actelion Pharmaceuticals US, Inc.Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization. | Drug | Inhaled Iloprost therapy |
Primary outcome
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.
7 secondary outcomes
Rates of endotracheal intubation
Time frame: 28 days
Invasive ventilation duration
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Hospital Length of stay
Time frame: 28 days
Rates of proning therapy
Time frame: 28 days
Rates of ECMO cannulation
Time frame: 28 days
Mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 34529182Mulia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadir Kharma, MD principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled ILOPROST in people with COVID-19 and ARDS, Human, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in oxygenation parameters (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.