Clinical trial NCT05276375: Effect of Bronchipret on Antiviral Immune Response in Patients With Mild COVID-19
Official title: Effect of Bronchipret on Antiviral Immune Response in Patients With Mild COVID-19 (BroVID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: ARDS
COVID 19
Bronchipret
Lead sponsor: Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Sponsor class: OTHER
Collaborators: name: Bionorica SE
First posted: 2022-03-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of Verum (Bronchipret) versus no verum i.d. standard of care
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in average concentration of immunologic markers
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - IL4
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - Interleukin (IL)-6
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - IL-8
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - IL-10
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - Interferon y
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers- c-reactive protein (CRP)
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - IL-1β
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - Interferon (INF) α
timeFrame: Comparison Baseline to day 7
measure: Change in average concentration of immunologic markers - TNFα
timeFrame: Comparison Baseline to day 7
measure: Change in average number of immunologic markers - neutrophils
timeFrame: Comparison Baseline to day 7
measure: Change in average number of immunologic markers - lymphocytes
timeFrame: Comparison Baseline to day 7
measure: Change in average number of immunologic markers - monocytes
timeFrame: Comparison Baseline to day 7
measure: Change in average number of immunologic markers - eosinophils
timeFrame: Comparison Baseline to day 7
measure: Change in average number of immunologic markers - basophils
timeFrame: Comparison Baseline to day 7
measure: Change in average number of immunologic markers - platelets
timeFrame: Comparison Baseline to day 7
Secondary outcomes:
measure: Concentration of blood parameters and change to BL - IL2
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): IL2
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): IL2
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): IL2
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): IL2
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage) IL4
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change): IL4
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage) IL4
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change) IL4
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage) IL4
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change) IL6
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage) IL6
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change) IL6
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage) IL6
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage) IL6
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change) IL6
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage) IL8
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change) IL8
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change IL8):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change IL10):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (IL10 percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change IL10):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): IL10
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change IL10):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): IL10
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (INFy percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change INFy):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): INFy
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): INFy
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): INFy
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): INFy
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): CRP
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): CRP
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change): CRP
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): CRP
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): CRP
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): CRP
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): IL-1β
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change): IL-1β
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): IL-1β
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): IL-1β
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): IL-1β
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): IL-1β
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): INFα
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): INFα
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):INFα
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): INFα
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): INFα
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): INFα
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): TNFα,
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): TNFα,
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change): TNFα,
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): TNFα,
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): TNFα,
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): TNFα,
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): neutrophils
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change): neutrophils
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): neutrophils
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): neutrophils
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): neutrophils
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): neutrophils
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): lymphocytes
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): lymphocytes
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change): lymphocytes
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): lymphocytes
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): lymphocytes
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): lymphocytes
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage): monocytes
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change): monocytes
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): monocytes
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): monocytes
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): monocytes
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): monocytes
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): eosinophils
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): eosinophils
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage): eosinophils
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change): eosinophils
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage): eosinophils
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change): eosinophils
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 4
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 7
measure: Concentration of blood parameters and change to BL (percentage):
timeFrame: Day 14
measure: Concentration of blood parameters and change to BL (absolute change):
timeFrame: Day 14
measure: Neutrophil to lymphocyte ratio
timeFrame: Day 4
measure: Neutrophil to lymphocyte ratio
timeFrame: Day 7
measure: Neutrophil to lymphocyte ratio
timeFrame: Day 14
measure: IL-6/IL-10 ratio
timeFrame: Day 4
measure: IL-6/IL-10 ratio
timeFrame: Day 7
measure: IL-6/IL-10 ratio
timeFrame: Day 14
measure: IL-6/INFy ratio
timeFrame: Day 14
measure: IL-6/INFy ratio
timeFrame: Day 7
measure: IL-6/INFy ratio
timeFrame: Day 4
measure: Assessment of symptom improvement/worsening
timeFrame: Day 4
measure: Assessment of symptom improvement/worsening
timeFrame: Day 7
measure: Assessment of symptom improvement/worsening
timeFrame: Day 14
measure: Assessment of symptom improvement/worsening
timeFrame: Day 28
measure: Assessment of number of symptoms
timeFrame: Day 4
measure: Assessment of number of symptoms
timeFrame: Day 7
measure: Assessment of number of symptoms
timeFrame: Day 14
measure: Assessment of number of symptoms
timeFrame: Day 28
measure: Assessment of symptom distribution
timeFrame: Day 4
measure: Assessment of symptom distribution
timeFrame: Day 7
measure: Assessment of symptom distribution
timeFrame: Day 14
measure: Assessment of symptom distribution
timeFrame: Day 28
measure: Assessment of defervescence
timeFrame: Day 28
measure: Assessment of defervescence - number of patients
timeFrame: Day 28
measure: Assessment of defervescence - portion of patients
timeFrame: Day 28
measure: Assessment of defervescence
timeFrame: Day 4
measure: Assessment of defervescence
timeFrame: Day 7
measure: Assessment of defervescence
timeFrame: Day 14
measure: Assessment of defervescence
timeFrame: Day 28
measure: Assessment of improvement or absence of coughing
timeFrame: Day 28
measure: Assessment of improvement or absence of coughing
timeFrame: Day 28
measure: Assessment of improvement or absence of coughing - proportion of patients
timeFrame: Day 28
measure: Assessment of improvement or absence of coughing - number of patients
timeFrame: Day 28
measure: Assessment of improvement or absence of coughing
timeFrame: Day 28
measure: Assessment of intensity and distribution of most bothersome symptom
timeFrame: Day 28
measure: Assessment of intensity and distribution of most bothersome symptom
timeFrame: Day 28
measure: Proportion of patients who return to usual health
timeFrame: Day 28
measure: Number of patients who return to usual health
timeFrame: Day 28
measure: proportion of patients who return to usual activity
timeFrame: Day 28
measure: Requirement of hospitalisation or oxygen supplementation
timeFrame: Day 28
measure: Requirement of hospitalisation or oxygen supplementation
timeFrame: Day 28
measure: Disease progression/improvement
timeFrame: Day 4
measure: Disease progression/improvement
timeFrame: Day 4
measure: Disease progression/improvement
timeFrame: Day 7
measure: Disease progression/improvement
timeFrame: Day 7
measure: Disease progression/improvement
timeFrame: Day 14
measure: Disease progression/improvement
timeFrame: Day 14
measure: Disease progression/improvement
timeFrame: Day 28
measure: Disease progression/improvement
timeFrame: Day 28
measure: Disease progression/improvement
timeFrame: Day 4
measure: Disease progression/improvement
timeFrame: Day 4
measure: Disease progression/improvement
timeFrame: Day 7
measure: Disease progression/improvement
timeFrame: Day 7
measure: Disease progression/improvement
timeFrame: Day 14
measure: Disease progression/improvement
timeFrame: Day 14
measure: Disease progression/improvement
timeFrame: Day 28
measure: Disease progression/improvement
timeFrame: Day 28
measure: Disease progression/improvement
timeFrame: Day 4
measure: Disease progression/improvement
timeFrame: Day 7
measure: Disease progression/improvement
timeFrame: Day 14
measure: Disease progression/improvement
timeFrame: Day 28
measure: Disease progression/improvement
timeFrame: Day 4
measure: Disease progression/improvement
timeFrame: Day 4
measure: Disease progression/improvement
timeFrame: Day 7
measure: Disease progression/improvement
timeFrame: Day 7
measure: Disease progression/improvement
timeFrame: Day 14
measure: Disease progression/improvement
timeFrame: Day 14
measure: Disease progression/improvement
timeFrame: Day 28
measure: Disease progression/improvement
timeFrame: Day 28
measure: Assessment of oxygen saturation
timeFrame: Day 4
measure: Assessment of oxygen saturation
timeFrame: Day 7
measure: Assessment of oxygen saturation
timeFrame: Day 14
measure: Assessment of oxygen saturation
timeFrame: Day 28
measure: Assessment of intake of concomitant medication
timeFrame: Day 14
measure: Assessment of intake of concomitant medication
timeFrame: Day 4
measure: Assessment of intake of concomitant medication
timeFrame: Day 7
measure: Assessment of intake of concomitant medication
timeFrame: Day 14
measure: Assessment of intake of concomitant medication
timeFrame: Day 28
measure: Assessment of intake of concomitant medication
timeFrame: Day 14
measure: Assessment of intake of concomitant medication
timeFrame: Day 14
measure: Number of patients with hyposmia or anosmia
timeFrame: Day 4
measure: proportion of patients with hyposmia or anosmia
timeFrame: Day 4
measure: Number of patients with hyposmia or anosmia
timeFrame: Day 7
measure: proportion of patients with hyposmia or anosmia
timeFrame: Day 7
measure: Number of patients with hyposmia or anosmia
timeFrame: Day 14
measure: proportion of patients with hyposmia or anosmia
timeFrame: Day 14
measure: Number of patients with hyposmia or anosmia
timeFrame: Day 28
measure: proportion of patients with hyposmia or anosmia
timeFrame: Day 28
measure: Number of patients with fever
timeFrame: Day 4
measure: proportion of patients with fever
timeFrame: Day 4
measure: Number of patients with fever
timeFrame: Day 7
measure: proportion of patients with fever
timeFrame: Day 7
measure: Number of patients with fever
timeFrame: Day 14
measure: proportion of patients with fever
timeFrame: Day 14
measure: Number of patients with fever
timeFrame: Day 28
measure: proportion of patients with fever
timeFrame: Day 28
measure: Number of patients with COVID-19 vaccination
timeFrame: Day 4
measure: proportions of patients with COVID-19 vaccination
timeFrame: Day 4
measure: Number of patients with COVID-19 vaccination
timeFrame: Day 7
measure: proportions of patients with COVID-19 vaccination
timeFrame: Day 7
measure: Number of patients with COVID-19 vaccination
timeFrame: Day 14
measure: proportions of patients with COVID-19 vaccination
timeFrame: Day 14
measure: Number of patients with COVID-19 vaccination
timeFrame: Day 28
measure: proportions of patients with COVID-19 vaccination
timeFrame: Day 28
measure: Number of recovered COVID-19 patients
timeFrame: Day 4
measure: proportion of recovered COVID-19 patients
timeFrame: Day 4
measure: Number of recovered COVID-19 patients
timeFrame: Day 7
measure: proportion of recovered COVID-19 patients
timeFrame: Day 7
measure: Number of recovered COVID-19 patients
timeFrame: Day 14
measure: proportion of recovered COVID-19 patients
timeFrame: Day 14
measure: Number of recovered COVID-19 patients
timeFrame: Day 28
measure: proportion of recovered COVID-19 patients
timeFrame: Day 28
measure: Assessment of severe acute respiratory syndrome (SARS)- Corona virus (CoV) -2 negativity
timeFrame: Day 4
measure: Assessment of SARS-CoV-2 negativity
timeFrame: Day 7
measure: Assessment of SARS-CoV-2 negativity
timeFrame: Day 14
measure: Assessment of SARS-CoV-2 negativity
timeFrame: Day 28
measure: Assessment of compliance
timeFrame: Day 4
measure: Assessment of compliance
timeFrame: Day 7
measure: Assessment of compliance
timeFrame: Day 14
measure: Number of adverse events (AE)
timeFrame: through study completion, average 28 days
measure: Number of serious adverse events (SAE)
timeFrame: through study completion, average 28 days
measure: Type and severity of adverse events
timeFrame: through study completion, average 28 days
measure: Type and severity of serious adverse events
timeFrame: through study completion, average 28 days
measure: Seriousness and relatedness of AEs
timeFrame: through study completion, average 28 days
measure: Seriousness and relatedness of SAEs
timeFrame: through study completion, average 28 days
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Fraunhofer ITMP - early clinical development
state: Hessia
Study officials:
affiliation: Fraunhofer ITMP
name: Stephan Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References: