Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT05070650
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects aged between 18 and 75 years inclusive on the date of consent
2. No fever or (mild) fever below 38.5° C
3. Total score (sum of all ratings) of 2 or higher based on the rating of the following symptoms of common cold (Jackson scale):
1. Sneezing
2. Nasal discharge
3. Nasal obstruction
4. Sore throat
5. Cough
6. Headache
7. Malaise
8. Chilliness according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe
4. Presence of cough with thick mucus production
5. Informed consent to participate in the trial provided in written form
Exclusion Criteria:
1. Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
2. History of hypersensitivity or intolerance to the active substances or any of the excipients of the trial medication
3. Known bronchial asthma or chronic obstructive pulmonary disease
4. Known duodenal or gastric ulcer
5. Known hyperthyroidism
6. Known narrow angle glaucoma
7. Known pheochromocytoma
8. Known prostate adenoma with urine retention
9. Known severe liver failure (Child-Pugh \> 9)
10. Known severe cardio-vascular diseases
11. Known porphyria
12. Known glucose-6-phosphate dehydrogenase deficiency
13. High fever (body temperature above 38.5°C)
14. Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulating medication, within 30 days prior to screening visit
15. Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
16. Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit
17. Vaccination within 14 days prior to screening visit
18. Immunocompromised state
19. Suspicion for acute bacterial infection
20. Pregnant or breast-feeding female patient
21. Female patient of childbearing potential (not surgically sterilized/ hysterectomized or postmenopausal for at least 1 year) who is not currently using (documented at screening visit) and not willing to use medically reliable methods of contraception for the entire trial duration such as barrier method, oral, injectable or implantable contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner
22. Any other condition of the patient (e.g. serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize patient's safety, compliance or adherence to protocol requirements
23. Participation in ANY research study involving another investigational medicinal product (IMP) within 30 days prior to screening visit, or simultaneous participation in another clinical study or previous participation in present study
24. Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)
25. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
26. Subjects who are known or suspected:
* not to comply with the trial directives
* not to be reliable or trustworthy
* to be a dependent person, e.g. a relative, family member, or member/ employee of the investigator's or sponsor's staff
* subject is in custody or submitted to an institution due to a judicial order.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05070650
Study Brief:
Protocol Section:
NCT05070650