A Phase 2 interventional study of Iloprost and Isotonic saline in Acute Respiratory Failure, Endothelial Dysfunction and Pulmonary Infection, sponsored by Pär Johansson. Recruiting at 5 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Pär Johansson · Phase 2, Interventional, and Treatment
The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival.
Acute respiratory failure (ARF) is common in critically ill patients and 50% of all intensive care unit patients require mechanical ventilation. ARF occurs in a heterogenous patient group, most often in the setting of pneumonia, sepsis, aspiration of gastric contents or severe trauma and major surgery. Despite improvements in intensive care capabilities, ARF mortality remains high and the only treatment option, to date, is supportive care. A recent Cochrane analysis (2018) found no evidence for that any drug was effective in reducing deaths in mechanically ventilated patients with ARF, highlighting the high unmet medical need.
Given that the pulmonary system, apart from the brain, is the most highly vascularized vital organ in the body, extensive endothelial damage is a central feature of acute respiratory distress syndrome (ARDS) with respiratory failure being the rationale for the current study. Evidence support that iloprost infusion significantly improved endothelial function and integrity in mechanically ventilated patients with COVID-19 infection with reducing 28-day mortality by 50%.
The main objective in this clinical trial is to investigate whether continuous infusion of low dose iloprost at a dose of 1 ng/kg/min for 72-hours is safe and significantly reduce all-cause mortality at day 28.
Patients that are eligible for this trial will be temporarily incompetent due to acute severe illness relating to respiratory failure.
During the trial, patient will be given continuous infusion of low dose iloprost or placebo for 72 hours during their stay at the intensive care unit (ICU) and additional blood samples will be obtained at baseline, 24-, 48 and 72-hours.
This trial is conducted in accordance with the Helsinki 2 Declaration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Good Clinical Practice (ICH-GCP) and in compliance with the protocol. As part of the quality assurance on-site monitoring visit will be performed by the an independent GCP-unit including source data verification. Standard Operation Procedure (SOP) will address protocol specific procedures.
Pär Johansson is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to active treatment (n=225 patients) will receive continuous infusion of iloprost for 72 hours after inclusion or until discharge to ward or death, whichever comes first.
Drug: Iloprost
Patients randomized to placebo treatment (n=225 patients) will receive continuous infusion of placebo for 72 hours after inclusion or until discharge to ward or death, whichever comes first.
Drug: Isotonic saline
Continuously infusion for 72 hours at 3 ml/hours. Treatment dose 1 ng/kg/min
Also known as: Ilomedin
Continuously infusion for 72 hours at 3 ml/hours
28-day mortality
All-cause mortality at day 28
Time frame: Day 28
90-day mortality
All-cause mortality at day 90
Time frame: Day 90
Vasopressor-free days
Days alive without vasopressor in the ICU within 28- and 90 days
Time frame: Until ICU discharge, maximun 90 days after randomization]
Renal replacement-free days
Days alive without renal replacement in the ICU within 28- and 90 days
Time frame: Until ICU discharge, maximun 90 days after randomization]
Mechanical ventilation free days
Days alive without mechanical ventilation in the ICU within 28- and 90 days
Time frame: Until ICU discharge, maximun 90 days after randomization]
Serious adverse reactions (SARs)
Total number and numbers of patient with one or more serious adverse reactions within the first 7 days
Time frame: Until day 7 after randomization
Serious adverse events (SAEs)
Total numbers and numbers of patients with one or more serious adverse events within the first 7 days
Time frame: Until day 7 after randomization
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Pär Johansson