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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT05916768
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (aged 18 and over) consulting for the first time, for the same episode, either for an acute cough (≤8 days) as the main symptom, suggestive of acute bronchitis, or for an illness (≤8 days) in which cough is not the main symptom but PCP believes that acute bronchitis is the most likely diagnosis.
* Patients tested positive to COVID-19 who meet the above-mentioned criteria will be included too.
Exclusion Criteria:
* Infection requiring antibiotic treatment (ex. cystic fibrosis)
* Pneumonia
* Known hypersensitivity to Pelargonium sidoides extract or excipients of the trial medication
* Non-infectious causes (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy)
* Lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression)
* Inability to fill out the diary (no ability to read and understand French)
* Pregnancy or breastfeeding
* Immunological deficiencies
* Hospitalization
* Severe hepatic disease
* Patients who have already started a treatment with Pelargonium sidoides EPs® 7630 for this current episode (Kaloba®, Umckaloabo®)
* Important risk of bleeding (severe thrombocytopenia and anticoagulant intake)
* If the patient is taking a drug among these classes of drugs:
anticoagulants, immunosuppressants, chemotherapy or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05916768
Study Brief:
Protocol Section:
NCT05916768