Effect of Bronchipret on Antiviral Immune Response in Patients With Mild COVID-19

NCT05276375 | Completed Phase 2

• 1 other identifier: TMP-2005-2020-36
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Keywords

ARDS; COVID 19; Bronchipret

Outcome Measures

Primary Outcomes (16)

• Change in average concentration of immunologic markers

  concentration of Interleukin 2 (IL-2)

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - IL4

  concentration of Interleukin (IL) 4

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - Interleukin (IL)-6

  concentration of IL-6

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - IL-8

  concentration of IL-8

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - IL-10

  concentration of IL-10

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - Interferon y

  concentration of interferon (INF) y

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers- c-reactive protein (CRP)

  concentration of c-reactive protein (CRP)

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - IL-1β

  concentration of IL-1β

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - Interferon (INF) α

  concentration of INFα

  Comparison Baseline to day 7

• Change in average concentration of immunologic markers - TNFα

  concentration of tumor necrosis factor alpha (TNFα)

  Comparison Baseline to day 7

• Change in average number of immunologic markers - neutrophils

  number of neutrophils

  Comparison Baseline to day 7

• Change in average number of immunologic markers - lymphocytes

  number of lymphocytes

  Comparison Baseline to day 7

• Change in average number of immunologic markers - monocytes

  number of monocytes

  Comparison Baseline to day 7

• Change in average number of immunologic markers - eosinophils

  number of eosinophils

  Comparison Baseline to day 7

• Change in average number of immunologic markers - basophils

  number of basophils

  Comparison Baseline to day 7

• Change in average number of immunologic markers - platelets

  number of platelets

  Comparison Baseline to day 7

Secondary Outcomes (302)

• Concentration of blood parameters and change to BL - IL2

  Day 4

• Concentration of blood parameters and change to BL

  Day 4

• Concentration of blood parameters and change to BL (percentage): IL2

  Day 7

• Concentration of blood parameters and change to BL (absolute change): IL2

  Day 7

• Concentration of blood parameters and change to BL (absolute change): IL2

  Day 14

Study Arms (2)

Bronchipret

ACTIVE COMPARATOR

Bronchipret syrup (3x 5,4 ml daily, according to summary of product characteristics) until day 14

Drug: Bronchipret

standard of care

NO INTERVENTION

no study intervention

Interventions

Bronchipret DRUG

Bronchipret syrup (3x 5,4 ml daily) until day 14

Bronchipret

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years and ≤ 75 years
• o If \> 50 years, complete COVID-19 vaccination mandatory
• SARS-CoV-2 infection confirmed by PCR test ≤ 4 days before screening/baseline visit
• Onset of the earliest symptoms \< 7 days before screening/baseline visit
• Mild COVID-19 with the following symptoms (outpatient management/non hospitalized patients):
• ᴑ Cough and ᴑ 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)
• Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient
• Willingness to comply to study procedures and study protocol

You may not qualify if:

• WHO score ≥ 3
• Other advanced or chronic lung diseases (Chronic obstructive pulmonary disease (COPD), silicosis, bronchial asthma)
• Unable to take oral medication
• Body mass index (BMI) \> 35 or ≤ 43kg
• Requirement for oxygen administration
• Current hospitalization
• 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
• Patients with rare hereditary fructose intolerance
• Inability to monitor body temperature
• Patients regularly taking immune suppressive medication, nonsteroidal anti-rheumatic drug(s) (NSARs) or steroids (e.g., because of underlying disease)
• 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.
• COVID-19 vaccination planned within study period and/or COVID-19 vaccination within the last 28 days
• Women pregnant (patient reported at pre-Screening and confirmation via pregnancy test at Screening/baseline) or nursing
• Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index \<1 - e.g. contraceptive pills/intra-uterine devices (IUD))
• Alcohol, drug or chemical abuse

Sponsors & Collaborators

• Dr. Frank Behrens: lead
• Bionorica SE: collaborator

Study Sites (1)

Fraunhofer ITMP - early clinical development

Frankfurt, Hessia, 60596, Germany

Location

MeSH Terms

Conditions

COVID-19

Interventions

thyme extract and ivy extract drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stephan Schaefer, MD

  Fraunhofer ITMP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor representative

Model Details: Comparison of Verum (Bronchipret) versus no verum i.d. standard of care

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: January 14, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)