- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04445246
Inhaled Iloprost for Suspected COVID-19 Respiratory Failure (ILOCOVID)
Inhaled Iloprost for the Treatment of Suspected COVID-19 Respiratory Failure
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Doha, Qatar
- Hamad medical corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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:
|
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
Sponsor
Investigators
- Principal Investigator: Nadir Kharma, MD, Hamad medical corporation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Respiratory Insufficiency
- Respiratory Distress Syndrome
- Vasodilator Agents
- Platelet Aggregation Inhibitors
- Iloprost
Other Study ID Numbers
- MRC-05-026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
First Affiliated Hospital Xi'an Jiaotong UniversityShangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin... and other collaboratorsRecruitingCOVID-19 | Post-COVID-19 Syndrome | Post-Acute COVID-19 | Acute COVID-19China
Clinical Trials on Inhaled ILOPROST
-
Heidelberg UniversityBayerWithdrawnPulmonary Hypertension | Chronic Left Ventricular FailureGermany
-
University of ChicagoTerminatedPulmonary HypertensionIsrael, United States
-
BayerCompletedHypertension, PulmonaryJapan
-
BayerCompleted
-
Yonsei UniversityNot yet recruitingMediastinal MassKorea, Republic of
-
Carmel Medical CenterUnknownChronic Obstructive Pulmonary DiseaseIsrael
-
BayerCompletedPulmonary HypertensionTurkey
-
Seoul St. Mary's HospitalThe Catholic University of KoreaCompletedLung CancerKorea, Republic of
-
BayerDra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)Completed
-
Yonsei UniversityCompletedChronic Obstructive Pulmonary Disease | Video-assisted Thoracoscopic SurgeryKorea, Republic of