Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
100
Countries
1
Sites
3
COVID-19 and other pulmonary parenchyma infections.
Improvement of respiratory capacity in patients who receive ITPP as adjunct therapy, as measured by an improvement in gasometric and biochemical parameters
Key facts
- Sponsor
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 28 Nov 2023 → 11 Jun 2025
- Decision date (initial)
- 2025-01-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Agencja Badań Medycznych
External identifiers
- EU CT number
- 2024-517878-21-00
- EudraCT number
- 2020-005158-50
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
Improvement of respiratory capacity in patients who receive ITPP as adjunct therapy, as measured by an improvement in gasometric and biochemical parameters
Secondary objectives 1
- Determination of the ITPP safety profile and tolerance.
Conditions and MedDRA coding
COVID-19 and other pulmonary parenchyma infections.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Hospitalized patients with pneumonia and respiratory failure caused by SARS-CoV-2 and/or other pathogens. Pneumonia will be diagnosed based on history, physical examination and imaging.
- Age >= 18 years.
- Neutrophil count above 500 / ml.
- A platelet count above 50,000 / ml.
- Total bilirubin level, creatinine level not exceeding three times the reference value.
- ALT, AST level not exceeding five times the reference values.
- Progressive severe respiratory failure, requiring aggressive mechanical ventilation within 14 days from admission to hospital (day 1). The criterion will be met when the patient meets two of the following parameters simultaneously: a. a spontaneous breathing rate greater than 35 bpm b. arterial oxygen pressure below 60 mm Hg despite mask oxygen therapy with a reservoir c. acute respiratory acidosis d. paO2 / fO2 ratio below 150 mmHg e. disturbance of consciousness.
Exclusion criteria 9
- The patient or the court did not give Informed Consent to participate in the Clinical Trial.
- Age under 18 years.
- Pregnancy.
- Severe, unmanageable electrolyte disturbances.
- Neutrophil count less than 500 / ml.
- Platelet count less than 50,000 / ml.
- Total bilirubin, creatinine levels greater than three times the reference value.
- ALT, AST levels greater than five times the reference value.
- Dependence on psychoactive substances and a history of their use within 30 days before the planned inclusion in the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Improvement of respiratory capacity in patients who receive ITPP as adjunct therapy, as measured by an improvement in gasometric and biochemical parameters.
Secondary endpoints 1
- Determination of the ITPP safety profile and tolerance.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11679430 · Product
- Active substance
- Inositol Trispyrophosphate Hexasodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 g gram(s)
- Max total dose
- 35 g gram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- WOJSKOWY INSTYTUT MEDYCZNY-PAŃSTWOWY INSTYTUT BADAWCZY
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
PRD463376 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 3500 ml millilitre(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- R/2484
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-packing
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Sponsor organisation
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Address
- Ulica Szaserow 128
- City
- Warsaw
- Postcode
- 04-141
- Country
- Poland
Scientific contact point
- Organisation
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Contact name
- Co-ordinating Investigator
Public contact point
- Organisation
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Contact name
- Sekcja Projektów Operacyjnych i Strategicznych
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 100 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Anaestesiology and Intensive Care Clinic Hospital in LEGIONOWO, Ulica Szaserow 128, 04-141, Warsaw
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department of Cardiology and Internal Diseases, Ulica Szaserow 128, 04-141, Warsaw
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Anesthesiology and Intensive Care and the Department of Internal Medicine, Infectious Diseases, Ulica Szaserow 128, 04-141, Warsaw
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 |
|---|---|---|---|---|---|
| Poland | 2023-11-28 | 2025-06-11 | 2023-11-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results EU CT 2024-517878-21-00 SUM-108161
|
2025-11-26T11:07:45 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results EU CT 2024-517878-21-00 | 2025-11-26T11:10:30 | Submitted | Laypersons Summary of Results |
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay person summary of results EU CT 2024-517878-21-00 | 1 |
| Protocol (for publication) | D1_Protocol_2024-517878-21-00_BLIND | 4.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_kontynuacja udzialu | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_wniosek do sadu | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_zgoda RODO | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_IMP extension of shelf-life to 36 months statement | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G1_Stability Report after 24 months | N/A |
| Summary of results (for publication) | Summary of results EU CT 2024-517878-21-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-29 | Poland | Acceptable 2025-01-08
|
2025-01-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-10 | Poland | Acceptable 2025-01-08
|
2025-02-10 |