Adult patients suffering from mild COVID-19 with cough and at least one other symptoms will be recruited for this study. MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: PT Classification code 10011224 Term: Cough System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Bronchipret syrup
Product Name: Bronchipret
Pharmaceutical Form: Syrup
Sponsors
Fraunhofer Gesellschaft for its Institute for translationale Medicine and Pharmacology ITMP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients = 18 years and = 75 years If > 50 years, complete COVID-19 vaccination mandatory 2. SARS-CoV-2 infection confirmed by PCR test = 4 days before screening/baseline visit 3. Onset of symptoms =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. WHO score = 3 2. Other advanced or chronic lung diseases (COPD, silicosis, bronchial asthma) 3. Unable to take oral medication 4. BMI > 35 or = 43 kg 5. Requirement for oxygen administration 6. Current hospitalization 7. Known hypersensitivity to the active substances ivy, thyme, plants of the aralia family or other labiates (Lamiaceae), birch, mugwort, celery or to any of the excipients 8. Patients with rare hereditary fructose intolerance 9. Inability to monitor body temperature 10. Patients regularily taking immune suprressive medication, NSARs or steroids (e.g., because of underlying disease) 11. Known significant concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient’s safety and with the study outcome such as stem cell or organ transplantation within the last 5 years, cardiovascular disease, diabetes mellitus, chronic liver disease, chronic kidney disease including dialysis patients, sickle cell anemia or thalassemia, and other forms of immunosuppression (e.g. tumor patients, HIV-infected patients with weakened immune system, iatrogenic immunosuppression) as judged by the study physician according to patient’s reports 12. COVID-19 vaccination planned within study period and/or COVID-19 vaccination within the last 28 days 13. Women pregnant (patient reported at pre-SCR and confirmation via pregnancy test at BL) or nursing 14. Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index <1 - e.g. contraceptive pill, IUD) 15. Alcohol, drug or chemical abuse 16. Current participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary objective is to demonstrate a clinically relevant treatment difference in several blood parameters involved in the immune response at day 7 between patients receiving Bronchipret vs. patients not receiving Bronchipret. Co-primary endpoints: Difference in average concentration/numbers of: - IL-2, IL-4, IL-6, IL-8, IL-10, INFy, CRP, IL-1ß, IFNa, TNFa - neutrophils, lymphozytes, monocytes, eosinophils, basophils, platelets at day 7 compared to BL compared between patients receiving Bronchipret and patients in the control group;Timepoint(s) of evaluation of this end point: BL, Day 7;Main Objective: The primary objective is to demonstrate a clinically relevant treatment difference in several blood parameters involved in the immune response at day 7 between patients receiving Bronchipret vs. patients not receiving Bronchipret. ;Secondary Objective: 1. Assessment of blood parameters: a. Endpoints: Concentration/Number of following blood parameters and change to BL (absolute change and percentage) b. Neutrophil to lymphocyte ratio, IL6/IL-10 ratio, and IL-6/IFNy ratio 2. Assessment of symptom improvement/worsening and assessment of number of symptoms and symptom distribution 3. Assessment of defervescence (for patients with fever at BL) 4. Assessment of improvement or absence of coughing 5. Assessment of intensity and distribution of most bothersome symptom (VAS) (the most bothersome symptom will be defined by the patient at BL) 6. Assessment of quality of Life 7. Requirement of hospitalisation or oxygen supplementation 8. Disease progression/improvement 9. Assessment of oxygen saturation 10. Assessment of intake of concomitant medication 11. Subgroup analysis of efficacy endpoints 12. Assessment of SARS-CoV-2 negativity (PCR test) 13. Assessment of compliance 14. Safety assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Concentration/Number of blood parameters and change to BL - FDA symptom questionnaire score and change to BL - Number and percentage of patients with no symptoms or only mild symptoms - Time to all items of questionnaire = 1 or 0 - Number of symptoms according to the FDA questionnaire and change to BL - Mean score of encountered symptoms and change to BL - Symptom distribution - Time to defervescence in days - Number and proportion of patients who achieved defervescence - Absolute temperature values and change to BL - Time to cough reported as mild oder non existent in days - Time to non-existent coughing for all patients in days - Number and proportion of patients with moderate or severe cough at BL who achieved cough reported as mild or none existent - Number and proportion of patients who achieved cough reported as none existent - Most bothersome symptom distribution (i.e., percentage of patients with each symptom) - Intensity of most bothersome symptom (VAS) and change to BL - Number and proportion of patients who return to usual health - Number and proportion of patients who return to ususal activity - Number and proportion of patients requiring hospitalisation or oxygen supplementation - Number and proportion of patients with improved or progressed disease state (according to WHO scale) - Proportion of patients with each WHO score - WHO score and change to BL - Number and proportion of patients in each disease severity state (uninfected, mild, moderate, severe, dead) according to WHO score - Oxygen saturation and change to BL - Type and average daily dose of concomitant medication and total dose until day 14 (paracetamol) - Average days of additional intake of concomitant medication - Number and proportion of patients with a reduction in concomitant medication intake -Number and proportion of patients with hyposmia or anosmia - Number and proportion of patients with fever - Number and proportion of patients with COVID-19 vaccina | — |
Countries
Germany
Contacts
Public ContactProject management
Fraunhofer ITMP
Outcome results
None listed