Effect of Bronchipret on patient with mild Covid disease

Phase 1

• Conditions: Adult patients suffering from mild COVID-19 with cough and at least one other symptoms will be recruited for this study.; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; MedDRA version: 20.0Level: PTClassification code 10011224Term: CoughSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-003237-11-DE
• Lead Sponsor: Fraunhofer Gesellschaft for its Institute for translationale Medicine and Pharmacology ITMP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 < 7 days before screening/baseline visit
4. Mild COVID-19 with the following symptoms (outpatient management/non hospitalized patients):
? Cough and
? At least one other symptom (e.g., sore throat, nasal congestion, headache, nausea, low energy/fatigue, muscle or body ache, shortness of breath, fever, diarrhea, altered sense of smell or taste)
5. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient
6. Willingness to comply to study procedures and study protocol
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified