Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure
NCT04420741 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-05-07
Summary
The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 80 patients with COVID-19 suffering from 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 COVID-19 patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival. 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 COMBAT-COVID-19.
Conditions
Interventions
- DRUG
-
Iloprost
Continuously infusion for 72 hours at 3 ml/hours. Treatment dose 1 ng/kg/min
- DRUG
-
Isotonic saline
Continuously infusion for 72 hours at 3 ml/hours
Sponsors & Collaborators
-
Pär Johansson
lead OTHER
Principal Investigators
-
Anders Perner, MD, PhD · Copenhagen University Hospital, Intensive care Unit 4131
-
Pär I Johansson, MD, DMSc · Copenhagen University Hospital, Capital Blood Bank 2034
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-15
- Primary Completion
- 2021-02-23
- Completion
- 2021-04-23
Countries
- Denmark
Study Locations
More Related Trials
-
Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction
NCT03620526 ·Status: UNKNOWN ·Phase: PHASE4
-
Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation
NCT02490657 ·Status: COMPLETED ·Phase: NA
-
Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
NCT00109681 ·Status: COMPLETED ·Phase: PHASE2
-
Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension
NCT00314548 ·Status: COMPLETED ·Phase: NA
-
Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis
NCT00439543 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
NCT04598191 ·Status: UNKNOWN ·Phase: NA
-
Iloprost Power 15 in Pulmonary Arterial Hypertension
NCT00709956 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude
NCT00708565 ·Status: UNKNOWN ·Phase: PHASE1
-
Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection
NCT04357730 ·Status: COMPLETED ·Phase: PHASE2
-
Iloprost in Acute Respiratory Distress Syndrome
NCT03111212 ·Status: COMPLETED ·Phase: PHASE3
-
Iloprost in High Risk Cardiac Surgical Patients
NCT00927654 ·Status: COMPLETED ·Phase: PHASE3
-
Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
NCT02170519 ·Status: TERMINATED ·Phase: PHASE4
-
Hemodynamic Effects of Inhaled Iloprost in PH-COPD (HOLLYWOOD)
NCT07263958 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Iloprost for Bridging to Heart Transplantation in PH
NCT02482402 ·Status: WITHDRAWN ·Phase: PHASE2
-
Outpatient Vasodilator Assessment Using Iloprost in Pulmonary Hypertension
NCT03044314 ·Status: TERMINATED ·Phase: PHASE4
-
Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest
NCT03079102 ·Status: TERMINATED ·Phase: PHASE2
-
Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
NCT00409526 ·Status: TERMINATED ·Phase: PHASE4
-
PGE1 as Additive Anticoagulant in ECMO-Therapy
NCT02895373 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in COVID-19 Patients With Acute Pulmonary Hypertension
NCT04885491 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
NCT01320878 ·Status: COMPLETED ·Phase: PHASE2
-
Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension
NCT04578223 ·Status: COMPLETED
-
Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension
NCT00453414 ·Status: WITHDRAWN ·Phase: PHASE2
-
Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease
NCT01319045 ·Status: TERMINATED ·Phase: NA
-
Aerosolized Randomized Iloprost Study II (AIR - II) Long-Term Safety, Tolerability, and Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension
NCT00414687 ·Status: COMPLETED ·Phase: PHASE2
-
Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
NCT00060450 ·Status: TERMINATED ·Phase: PHASE3