Clinical Trials Register

Summary
EudraCT Number:	2021-003897-30
Sponsor's Protocol Code Number:	AERD-COV19
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-03-22
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2021-003897-30

A.3

Full title of the trial

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

Przewlekłe stosowanie aspiryny jako czynnik prognostyczny obniżonej podatności na zakażenie wirusem SARS-CoV-2 w chorobie dróg oddechowych zaostrzanej
aspiryną

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Przewlekłe stosowanie aspiryny jako czynnik prognostyczny obniżonej podatności na zakażenie wirusem SARS-CoV-2 w chorobie dróg oddechowych zaostrzanej
aspiryną

A.3.2

Name or abbreviated title of the trial where available

AERD-COV19

A.4.1

Sponsor's protocol code number

AERD-COV19

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Jagiellonian University Medical College
B.1.3.4	Country	Poland
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Narodowe Centrum Nauki
B.4.2	Country	Poland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Jagiellonian University Medical College
B.5.2	Functional name of contact point	Clinical Trial Office
B.5.3	Address:
B.5.3.1	Street Address	Podwale 3/6
B.5.3.2	Town/ city	Cracow
B.5.3.3	Post code	31-118
B.5.3.4	Country	Poland
B.5.6	E-mail	badania.kliniczne@uj.edu.pl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Acard 300 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Warszawskie Zakłady Farmaceutyczne Polfa S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Poland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACETYLSALICYLIC ACID
D.3.9.1	CAS number	50-78-2
D.3.9.4	EV Substance Code	SUB12730MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

aspirin-exacerbated respiratory disease

Choroba dróg oddechowych zaostrzana aspiryną (AERD)

E.1.1.1

Medical condition in easily understood language

aspirin-exacerbated respiratory disease

Choroba dróg oddechowych zaostrzana aspiryną (AERD)

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10003534
E.1.2	Term	Aspirin-sensitive asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10075084
E.1.2	Term	Aspirin-exacerbated respiratory disease
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Asessment of genetic features that might predict or attenuate SARS-CoV-2 infection on high-dose aspirin therapy.

Ocena czynników genetycznych, mogących służyć jako czynniki prognostyczne obniżonej podatności na zakażenie wirusem SARS-CoV-2 w trakcie leczenia wysokimi dawkami aspiryny.

E.2.2

Secondary objectives of the trial

not applicable

E.2.3

Trial contains a sub-study

E.3

Principal 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

KRYTERIA WŁĄCZENIA DLA UCZESTNIKÓW CHORYCH NA AERD
• Świadoma zgoda pacjenta na udział w badaniu.
• Chorzy na astmę w wieku 18-70 lat z nadwrażliwością na aspirynę potwierdzoną prowokacyjnym testem z aspiryną (AERD) (astma o różnym stopniu ciężkości) – na podstawie historii choroby pacjenta.
• Wartość FEV1 pacjentów w momencie kwalifikacji będzie wynosiła co najmniej 70% wartości należnej (w przypadku osób zdrowych – 80%).
• Brak ciąży, kobiety w wieku rozrodczym chętne do wzięcia udziału w badaniu zostaną poproszone o zobowiązanie się w formie pisemnej (Formularz Świadomej Zgody), że podczas całego czasu trwania badania będą stosowały wysoce skuteczne metody antykoncepcyjne

KRYTERIA WŁĄCZENIA DLA ZDROWYCH UCZESTNIKÓW
• Świadoma zgoda pacjenta na udział w badaniu. Wiek 18-70 lat
• Brak zdiagnozowanej astmy w wywiadzie medycznym
• Ogólne dobre samopoczucie deklarowane przez uczestnika

E.4

Principal 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

•Znaczna niewydolność układu krążenia i oddychania, wątroby, nerek, i innych narządów ważnych życiowo,
•cukrzyca,
•choroby nowotworowe,
•choroby układowe tkanki łącznej,
•choroby infekcyjne,
•zaburzenia krzepnięcia (dotyczy chorób hematologicznych jak i nieprawidłowych wskaźników krzepnięcia np., niskie płytki, nieprawidłowe wartości INR, APTT),
•czynna choroba wrzodowa,
•jakikolwiek aktywny proces krwawienia.
•Stosowanie leków wchodzących w interakcje z aspiryną np. leki hipotensyjne, furosemid, tiazydy, beznzbromaron, probenecyd, antagoniści wit. K, azotany leki przeciwcukrzyco-we, kwas walproinowy, digoksyna, metotreksat, leki trombolityczne, leki hamujące czynności płytek krwi, inne NLPZ, kortykosteroidy, omeprazol.
•stosowanie środków odurzających,
•nadużywanie alkoholu,
•czynne i bierne palenie papierosów,
•ciąża, laktacja.
•nadwrażliwość na substancję czynną lub którąkolwiek substancję pomocniczą

E.5 End points

E.5.1

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.

Zmiany ekspresji genów odpowiedzialnych za wnikanie wirusa SARS-CoV 2 do komórek: IFNA1, IFNB1, IFNG, IFNL1, IFNL2, BSG, PPIA, PPIB, DPP4, ISG, ICAM-1 oraz ACE2 i TMPRSS2 w komórkach plwociny i nosa.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit after end of IMP/PLACEBO taking

wizyty przeprowadzane na zakończenie interwencji lekowej

E.5.2

Secondary end point(s)

Changes in concentration of eicosanoids, chemokines and cytokines.

Zmiany w stężeniach czynników zapalnych: eikozanoidów, chemokin oraz cytokin.

E.5.2.1

Timepoint(s) of evaluation of this end point

Visit after end of IMP/PLACEBO taking

wizyty przeprowadzane na zakończenie interwencji lekowej

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

brak

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-05-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-15

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
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