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

NCT ID: NCT05276375

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-14
• Study Completion Date: 2023-06-30

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.

Detailed Description

Although intensive research efforts have been underway worldwide, so far, only few effective treatment against the disease has been brought to the market in Germany. Based on the pathological features and different clinical phases of COVID-19, particularly in patients with moderate to severe COVID- 19, the classes of drugs used are antiviral agents (e.g., remdesivir), inflammation inhibitors/antirheumatic drugs (e.g., dexamethasone), low molecular weight heparins, plasma, and hyperimmune immunoglobulins Bronchipret exhibits multidirectional anti-inflammatory effects as demonstrated in vitro and in vivo studies. Several clinical trials have demonstrated positive effects of Bronchipret, a fixed combination of thyme herb and ivy leaf fluid extracts, on symptom relieve and recovery time in patients with acute bronchitis and cough. There is currently an urgent need for effective and safe treatments of COVID- 19 and the cytokine storm that is responsible for the development of 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 will be 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bronchipret

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

Group Type: ACTIVE_COMPARATOR

Bronchipret

Intervention Type: DRUG

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

standard of care

no study intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bronchipret

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients ≥ 18 years and ≤ 75 years

o 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 the earliest symptoms < 7 days before screening/baseline visit

4. 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)

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

Exclusion Criteria

1. WHO score ≥ 3

2. Other advanced or chronic lung diseases (Chronic obstructive pulmonary disease (COPD), silicosis, bronchial asthma)

3. Unable to take oral medication

4. Body mass index (BMI) > 35 or ≤ 43kg

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 regularly taking immune suppressive medication, nonsteroidal anti-rheumatic drug(s) (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-Screening and confirmation via pregnancy test at Screening/baseline) or nursing

14. 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))

15. Alcohol, drug or chemical abuse

16. Current participation in another interventional clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bionorica SE

INDUSTRY

Sponsor Role: collaborator

Dr. Frank Behrens

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frank Behrens

Sponsor representative

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephan Schaefer, MD

Role: PRINCIPAL_INVESTIGATOR

Fraunhofer ITMP

Locations

Fraunhofer ITMP - early clinical development

Frankfurt, Hessia, Germany

Countries

Germany

Other Identifiers

TMP-2005-2020-36

Identifier Type: -

Identifier Source: org_study_id