Overview
Sponsor-declared trial summary
aspirin-exacerbated respiratory disease
to determine whether treatment with aspirin, which inhibits cyclooxygenase-1 enzyme, can serve as a predictor of decreased susceptibility to SARS-CoV-2 infection and COVID-19 in patients with AERD. 2. to assess genetic features that might predict or attenuate SARS-CoV-2 infection on high-dose aspirin therapy.
Key facts
- Sponsor
- Uniwersytet Jagiellonski Collegium Medicum
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 7 Dec 2022 → 23 Jan 2025
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514602-31-00
- EudraCT number
- 2021-003897-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
to determine whether treatment with aspirin, which inhibits cyclooxygenase-1 enzyme, can serve as a predictor of decreased susceptibility to SARS-CoV-2 infection and COVID-19 in patients with AERD.
2. to assess genetic features that might predict or attenuate SARS-CoV-2 infection on high-dose aspirin therapy.
Conditions and MedDRA coding
aspirin-exacerbated respiratory disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10003534 | Aspirin-sensitive asthma | 10038738 |
| 25.1 | LLT | 10075084 | Aspirin-exacerbated respiratory disease | 100000004855 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- INCLUSION CRITERIA FOR AERD PATIENTS:* signed informed consent form * 18-70 years old AERD patients with baseline FEV1 of at least 70% of the predicted value on the challenge/desensitization day * no pregnancy, higly effective contraception must be used
- INCLUSION CRITERIA FOR HEALTHY CONTROL: * signed informed consent form * 18-70 years old and healthy condition * no asthma
Exclusion criteria 6
- failure of the circulatory and respiratory system, liver, kidneys and other vital organs
- diabetes, cancer, systemic diseases of connective tissue, infectious diseases, coagulation disorders, active peptic ulcer disease, any active bleeding process.
- Use of drugs that interact with aspirin
- use of intoxicants, alcohol abuse, active and passive smoking
- pregnancy, lactation
- hypersensitivity to the active substance or any of the excipients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- whether aspirin desensitization followed by long-term high-dose aspirin therapy in patients with AERD associated with lower gene expression of ACE2, TMPRSS2, BSG, PPIA, PPIB, DPP4, IFNA1, IFNB1 IFNG, IFNL1 i IFNL2 and ISG in sputum and nasal cells.
Secondary endpoints 1
- Whether the change of gene expression during aspirin therapy is connected with lower risk of SARS-CoV-2 infection
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
ACARD 300 mg, 300 mg, tabletki
PRD4434169 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 175 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 23458
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repack and blinding
Placebo 1
Microcrystalline cellulose, Native corn starch, Citric acid anhydrous (E330)
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uniwersytet Jagiellonski Collegium Medicum
- Sponsor organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Address
- Ul. Sw. Anny 12
- City
- Cracow
- Postcode
- 31-008
- Country
- Poland
Scientific contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Prof. Lucyna Mastalerz
Public contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Biuro ds Badań klinicznych
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 76 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2022-12-07 | 2025-01-23 | 2023-01-31 | 2025-01-23 |
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 result v1.0 SUM-69231
|
2026-05-20T08:31:02 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of result | 2026-05-20T08:32:01 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Streszczenie wynikow dla osob bez wiedzy fachowej | 1 |
| Summary of results (for publication) | Streszczenie wynikow badania klinicznego | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Poland | Acceptable 2024-06-26
|
2024-07-01 |