COVID-19 induced respiratory failure MedDRA version: 20.0 Level: LLT Classification code 10038696 Term: Respiratory failure (excl neonatal) System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10040050 Term: Sepsis NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Ilomedin
Product Name: Ilomedin
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Iloprost
CAS Number: 78919-13-8
Concentration unit: µg/ml microg
Sponsors
Section for Transfusion Medicine, Capital Region Blood bank, Copenhagen University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult intensive care patients (aged 18 years or above) Confirmed COVID-19 infection Need for mechanical ventilation (=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG) Known hypersensitivity to iloprost or to any of the other ingredients. Consent cannot be obtained Previously included in this trial or a prostacyclin trial within 30 days Withdrawal from active therapy Life-threatening bleeding defined by the treating physician Known severe heart failure (NYHA class IV) Suspected acute coronary syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether continuous infusion of iloprost at a dose of 1 ng/kg/min for 72-hours reduces the severity of respiratory failure in the ICU as compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): Days alive without mechanical ventilation in the ICU at day 28;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 28- and 90-day mortality Mean daily modified Sequential Organ Failure Assessment (SOFA) score in the ICU up to day 90 Days alive without vasopressor in the ICU at day 28 and day 90 Days alive without renal replacement in the ICU at day 28 and day 90 Days alive without mechanical ventilation in the ICU at day 90 Numbers of serious adverse reactions within the first 7 days Numbers of serious adverse events within the first 7 days ;Timepoint(s) of evaluation of this end point: day 7, day 28 and day 90 | — |
Countries
Denmark
Contacts
Public ContactKristine Pedersen
Section for Transfusion Medicine, Capital Region Blood Bank, Copenhagen University Hospital
Outcome results
None listed