Long-term aspirin therapy as a predictor of decreased susceptibility to SARS-CoV-2 infection in aspirin-exacerbated respiratory disease

Long-term aspirin therapy as a predictor of decreased susceptibility to SARS-CoV-2 infection in aspirin-exacerbated respiratory disease - AERD-COV19

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003897-30-PL

Enrollment

Registered

2022-03-22

Start date

2022-05-30

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aspirin-exacerbated respiratory disease MedDRA version: 21.1 Level: LLT Classification code 10003534 Term: Aspirin-sensitive asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10075084 Term: Aspirin-exacerbated respiratory disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Acard 300 mg Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLSALICYLIC ACID CAS Number: 50-78-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: * 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Asessment of genetic features that might predict or attenuate SARS-CoV-2 infection on high-dose aspirin therapy.;Secondary Objective: not applicable;Primary end point(s): Changes in gene expression of ACE2, TMPRSS2, BSG, PPIA, PPIB, DPP4, IFNA1, IFNB1 IFNG, IFNL1 i IFNL2 and ISG in sputum and nasal cells. ;Timepoint(s) of evaluation of this end point: Visit after end of IMP/PLACEBO taking	—

Measure

Time frame

Main Objective: Asessment of genetic features that might predict or attenuate SARS-CoV-2 infection on high-dose aspirin therapy.;Secondary Objective: not applicable;Primary end point(s): Changes in gene expression of ACE2, TMPRSS2, BSG, PPIA, PPIB, DPP4, IFNA1, IFNB1 IFNG, IFNL1 i IFNL2 and ISG in sputum and nasal cells. ;Timepoint(s) of evaluation of this end point: Visit after end of IMP/PLACEBO taking

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in concentration of eicosanoids, chemokines and cytokines.;Timepoint(s) of evaluation of this end point: Visit after end of IMP/PLACEBO taking	—

Countries

Poland

Contacts

Public ContactClinical Trial Office

Jagiellonian University Medical College

badania.kliniczne@uj.edu.pl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026