Effect of Bronchipret on Antiviral Immune Response in Patients With Mild COVID-19
NCT05276375 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2024-08-28
Summary
There is currently an urgent need for effective and safe treatments of Coronavirus Disease (COVID) - 19 and the cytokine storm that is responsible for the development of patient's Acute Respiratory Distress Syndrome (ARDS).
As Bronchipret has been proven to be a very safe medicine, it is not expected that it would lead to the development of severe adverse effects in COVID-19 patients. Bronchipret can therefore be recommended as effective and safe supplementary treatments of COVID-19, even more so considering the positive effects shown in vitro. Thus, this randomized study is conducted to assess the effect of Bronchipret on the immune response and recovery in patients with mild COVID-19 by assessing several blood parameters as well as the symptom recovery and improvement in comparison to patients who do not receive Bronchipret. Another aim of this feasibility study is to determine the best possible primary endpoint, i.e. which shows the greatest effect according to Cohen.
Conditions
Interventions
- DRUG
-
Bronchipret
Bronchipret syrup (3x 5,4 ml daily) until day 14
Sponsors & Collaborators
-
Bionorica SE
collaborator INDUSTRY -
Dr. Frank Behrens
lead OTHER
Principal Investigators
-
Stephan Schaefer, MD · Fraunhofer ITMP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-14
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
Countries
- Germany
Study Locations
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