Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
450
Countries
1
Sites
5
Infectious pulmonary endotheliopathy
The primary objective is to investigate whether continuous infusion of iloprost at a dose of 1 ng/kg/min for 72-hours reduces the 28-day mortality as compared to placebo.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 15 Apr 2024 → ongoing
- Decision date (initial)
- 2024-03-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Benzon Foundation · Novo Nordisk Foundation
External identifiers
- EU CT number
- 2024-512641-16-00
- EudraCT number
- 2022-004079-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
The primary objective is to investigate whether continuous infusion of iloprost at a dose of 1 ng/kg/min for 72-hours reduces the 28-day mortality as compared to placebo.
Conditions and MedDRA coding
Infectious pulmonary endotheliopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10038696 | Respiratory failure (excl neonatal) | 10038738 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult intensive care patients (aged 18 years or above)
- Suspected pulmonary infection
- Need for high-flow (min. 20 l/min) oxygen therapy with a minimum FiO2 of 50% or need for mechanical ventilation (< 24hours from time of screening)
- Endothelial biomarker (sTM) ≥ 4 ng/mL
Exclusion criteria 8
- Withdrawal from active therapy
- Septic shock according to Sepsis-3 AND sTM>10 ng/ml
- Known hypersensitivity to iloprost or to any of the other ingredients.
- Previously included in this trial or a prostacyclin trial within 30 days
- Life-threatening bleeding defined by the treating physician
- Known severe heart failure (NYHA class IV)
- Suspected acute coronary syndrome
- Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 28-day all cause mortality
Secondary endpoints 6
- 90-day mortality
- Days alive without vasopressor in the ICU within 28-and 90 days
- Days alive without mechanical ventilation in the ICU within 28 -and 90 days
- Days without renal replacement in the ICU within 28-and 90 days
- Numbers of serious adverse reactions within the first 7 days
- Numbers of serious adverse events within the first 7 days
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ilomedin, koncentrat til infusionsvæske, opløsning
PRD445715 · Product
- Active substance
- Iloprost Trometamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Max daily dose
- 12.3 ml millilitre(s)
- Max total dose
- 36.9 ml millilitre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC11 — ILOPROST
- Marketing authorisation
- 19398
- MA holder
- BAYER AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
PRD567885 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 300 ml millilitre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 13040
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Pär I Johansson
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Kristine Holst Holst Pedersen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 450 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Region Hovedstaden
Intensive care unit, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Region Hovedstaden
Intensive care unit, Kettegaard Alle 30, 2650, Hvidovre
Region Sjaelland
Intensive Care, Lykkebaekvej 1, 4600, Koege
Region Hovedstaden
Intensive care unit, Borgmester Ib Juuls Vej 1, 2730, Herlev
Nordsjaellands Hospital
Intensive care unit, Dyrehavevej 29, 3400, Hilleroed
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-04-15 | 2024-04-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 30 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol 2022-004079-17_Redacted version | 1.4 |
| Recruitment arrangements (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangments | 1 |
| Subject information and informed consent form (for publication) | ICF_Legal guardian | 1.0 |
| Subject information and informed consent form (for publication) | ICF_Legal guardian_Biobank | 1.0 |
| Subject information and informed consent form (for publication) | ICF_Patient | 1.0 |
| Subject information and informed consent form (for publication) | ICF_Patient_Biobank | 1.0 |
| Subject information and informed consent form (for publication) | ICF_Relatives | 1.0 |
| Subject information and informed consent form (for publication) | ICF_Relatives_Biobank | 1.0 |
| Subject information and informed consent form (for publication) | SIS Parrende-Biobank TC | 1.2 |
| Subject information and informed consent form (for publication) | SIS Video og talepapir | 1.1 |
| Subject information and informed consent form (for publication) | SIS Video og talepapir TC | 1.1 |
| Subject information and informed consent form (for publication) | SIS_Patient_Biobank_Redacted version | 1.1 |
| Subject information and informed consent form (for publication) | SIS_Patient_Redacted version | 1.2 |
| Subject information and informed consent form (for publication) | SIS_Relative_mors_Redacted version | 1.2 |
| Subject information and informed consent form (for publication) | SIS_Relatives_Biobank_Redacted version | 1.1 |
| Subject information and informed consent form (for publication) | SIS_Relatives_Redacted version | 1.2 |
| Subject information and informed consent form (for publication) | SIS-Legal Guardian | 1.2 |
| Subject information and informed consent form (for publication) | SIS-Legal Guardian TC | 1.2 |
| Subject information and informed consent form (for publication) | SIS-Patient | 1.3 |
| Subject information and informed consent form (for publication) | SIS-Patient TC | 1.3 |
| Subject information and informed consent form (for publication) | SIS-Patient-Biobank | 1.2 |
| Subject information and informed consent form (for publication) | SIS-Patient-Biobank TC | 1.2 |
| Subject information and informed consent form (for publication) | SIS-Relatives | 1.3 |
| Subject information and informed consent form (for publication) | SIS-Relatives TC | 1.3 |
| Subject information and informed consent form (for publication) | SIS-Relatives-Biobank | 1.2 |
| Subject information and informed consent form (for publication) | SIS-Relatives-mors | 1.3 |
| Subject information and informed consent form (for publication) | SIS-Relatives-mors TC | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Ilomedin | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_ENG_2022-004079-17 | 1.3 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-11 | Denmark | Acceptable 2024-03-22
|
2024-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-03 | Denmark | Acceptable | 2024-07-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-02 | Denmark | Acceptable with conditions 2025-05-09
|
2025-05-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-04 | Denmark | Acceptable with conditions | 2026-01-26 |