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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Bronchipret syrup (3x 5,4 ml daily) until day 14
Fraunhofer ITMP - early clinical development
Frankfurt, Hessia, Germany
Change in average concentration of immunologic markers
concentration of Interleukin 2 (IL-2)
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - IL4
concentration of Interleukin (IL) 4
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - Interleukin (IL)-6
concentration of IL-6
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - IL-8
concentration of IL-8
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - IL-10
concentration of IL-10
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - Interferon y
concentration of interferon (INF) y
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers- c-reactive protein (CRP)
concentration of c-reactive protein (CRP)
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - IL-1β
concentration of IL-1β
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - Interferon (INF) α
concentration of INFα
Time frame: Comparison Baseline to day 7
Change in average concentration of immunologic markers - TNFα
concentration of tumor necrosis factor alpha (TNFα)
Time frame: Comparison Baseline to day 7
Change in average number of immunologic markers - neutrophils
number of neutrophils
Time frame: Comparison Baseline to day 7
Change in average number of immunologic markers - lymphocytes
number of lymphocytes
Time frame: Comparison Baseline to day 7
Change in average number of immunologic markers - monocytes
number of monocytes
Time frame: Comparison Baseline to day 7
Change in average number of immunologic markers - eosinophils
number of eosinophils
Time frame: Comparison Baseline to day 7
Change in average number of immunologic markers - basophils
number of basophils
Time frame: Comparison Baseline to day 7
Change in average number of immunologic markers - platelets
number of platelets
Time frame: Comparison Baseline to day 7
Concentration of blood parameters and change to BL - IL2
percentage of change of concentration of IL-2
Time frame: Day 4
Concentration of blood parameters and change to BL
absolute change of concentration of IL-2
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): IL2
percentage of change of concentration of IL-2
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): IL2
absolute change of concentration of IL-2
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): IL2
absolute change of concentration of IL-2
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): IL2
percentage of change of concentration of IL-2
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage) IL4
percentage of change of concentration of IL-4
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change): IL4
absolute change of concentration of IL-4
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage) IL4
percentage of change of concentration of IL-4
Time frame: Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Concentration of blood parameters and change to BL (absolute change) IL4
absolute change of concentration of IL-4
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage) IL4
percentage of change of concentration of IL-4
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change) IL6
absolute change of concentration of IL-6
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage) IL6
percentage of change of concentration of IL-6
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change) IL6
absolute change of concentration of IL-6
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage) IL6
percentage of change of concentration of IL-6
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage) IL6
percentage of change of concentration of IL-6
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change) IL6
absolute change of concentration of IL-6
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage) IL8
percentage of change of concentration of IL-8
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change) IL8
absolute change of concentration of IL-8
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of concentration of IL-8
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of concentration of IL-8
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of concentration of IL-8
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change IL8):
absolute change of concentration of IL-8
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change IL10):
absolute change of concentration of IL-10
Time frame: Day 4
Concentration of blood parameters and change to BL (IL10 percentage):
percentage of change of concentration of IL-10
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change IL10):
absolute change of concentration of IL-10
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): IL10
percentage of change of concentration of IL-10
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change IL10):
absolute change of concentration of IL-10
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): IL10
percentage of change of concentration of IL-10
Time frame: Day 14
Concentration of blood parameters and change to BL (INFy percentage):
percentage of change of concentration of INFy
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change INFy):
absolute change of concentration of INFy
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): INFy
percentage of change of concentration of INFy
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): INFy
absolute change of concentration of INFy
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): INFy
percentage of change of concentration of INFy
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): INFy
absolute change of concentration of INFy
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): CRP
absolute change of concentration of CRP
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): CRP
percentage of change of concentration of CRP
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change): CRP
absolute change of concentration of CRP
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): CRP
percentage of change of concentration of CRP
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): CRP
absolute change of concentration of CRP
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): CRP
percentage of change of concentration of CRP
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): IL-1β
percentage of change of concentration of IL-1β
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change): IL-1β
absolute change of concentration of IL-1β
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): IL-1β
percentage of change of concentration of IL-1β
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): IL-1β
absolute change of concentration of IL-1β
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): IL-1β
percentage of change of concentration of IL-1β
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): IL-1β
absolute change of concentration of IL-1β
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): INFα
absolute change of concentration of INFα
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): INFα
percentage of change of concentration of INFα
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):INFα
absolute change of concentration of INFα
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): INFα
percentage of change of concentration of INFα
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): INFα
percentage of change of concentration of INFα
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): INFα
absolute change of concentration of INFα
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): TNFα,
absolute change of concentration of TNFα,
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): TNFα,
percentage of change of concentration of TNFα,
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change): TNFα,
absolute change of concentration of TNFα,
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): TNFα,
percentage of concentration of TNFα,
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): TNFα,
absolute change of concentration of TNFα,
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): TNFα,
percentage of change of concentration of TNFα,
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): neutrophils
percentage change of neutrophils
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change): neutrophils
absolute change of neutrophils number
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): neutrophils
percentage change of neutrophils
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): neutrophils
absolute change of neutrophils number
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): neutrophils
percentage change of neutrophils
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): neutrophils
absolute change of neutrophils number
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): lymphocytes
absolute change of lymphocytes number
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): lymphocytes
percentage change of lymphocytes
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change): lymphocytes
absolute change of lymphocytes number
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): lymphocytes
percentage change of lymphocytes
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): lymphocytes
absolute change of lymphocytes number
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): lymphocytes
percentage change of lymphocytes
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage): monocytes
percentage change of monocytes
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change): monocytes
absolute change of monocytes number
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): monocytes
percentage change of monocytes
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): monocytes
absolute change of monocytes number
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): monocytes
percentage of change of monocytes
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): monocytes
absolute change of monocytes number
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): eosinophils
absolute change of eosinophils number
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): eosinophils
percentage of change of eosinophils
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage): eosinophils
percentage of change of eosinophils
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change): eosinophils
absolute change of eosinophils number
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage): eosinophils
percentage of change of eosinophils
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change): eosinophils
absolute change of eosinophils number
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of basophils number
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of basophils number
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of basophils number
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of basophils
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of basophils number
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of basophils
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of platelets
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of platelet number
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of platelets
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of platelet number
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of platelets
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of platelet number
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of lactate dehydrogenase (LDH)
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of lactate dehydrogenase (LDH)
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of LDH
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of LDH
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of LDH
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of LDH
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of ferritin
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of ferritin
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of ferritin
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of ferritin
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of ferritin
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of ferritin
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of haemoglobin
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of haemoglobin
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of haemoglobin
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of haemoglobin
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of haemoglobin
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of haemoglobin
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of alanine aminotransferase (ALT)
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of alanine aminotransferase (ALT)
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of alanine aminotransferase (ALT)
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of alanine aminotransferase (ALT)
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of alanine aminotransferase (ALT)
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of alanine aminotransferase (ALT)
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of Aspartate aminotransferase (AST)
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of Aspartate aminotransferase (AST)
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of Aspartate aminotransferase (AST)
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of Aspartate aminotransferase (AST)
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of Aspartate aminotransferase (AST)
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of activated partial thromboplastin time
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of activated partial thromboplastin time
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of activated partial thromboplastin time
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of activated partial thromboplastin time
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of activated partial thromboplastin time
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of activated partial thromboplastin time
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of prothrombin Z
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of prothrombin Z
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of prothrombin Z
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of prothrombin Z
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of prothrombin Z
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of prothrombin Z
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of fibrinogen
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of fibrinogen
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of fibrinogen
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of fibrinogen
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of fibrinogen
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of fibrinogen
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of d-dimeric
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of d-dimeric
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of d-dimeric
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of d-dimeric
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of d-dimeric
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of d-dimeric
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of fibrin-degranulation products
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of fibrin-degranulation products
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of fibrin-degranulation products
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of fibrin-degranulation products
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of fibrin-degranulation products
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of fibrin-degranulation products
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of anti-thrombin III activity
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of anti-thrombin III activity
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of anti-thrombin III activity
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of anti-thrombin III activity
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of anti-thrombin III activity
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of anti-thrombin III activity
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of Immunglobulin M (IgM)
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of Immunglobulin M (IgM)
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of Immunglobulin M (IgM)
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of Immunglobulin M (IgM)
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of Immunglobulin M (IgM)
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of Immunglobulin M (IgM)
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of Immunglobulin G (IgG)
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of Immunglobulin G (IgG)
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of Immunglobulin G (IgG)
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of Immunglobulin G (IgG)
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of Immunglobulin G (IgG)
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of Immunglobulin G (IgG)
Time frame: Day 14
Concentration of blood parameters and change to BL (percentage):
percentage of change of Creatinin
Time frame: Day 4
Concentration of blood parameters and change to BL (absolute change):
absolute change of Creatinin
Time frame: Day 4
Concentration of blood parameters and change to BL (percentage):
percentage of change of Creatinin
Time frame: Day 7
Concentration of blood parameters and change to BL (absolute change):
absolute change of Creatinin
Time frame: Day 7
Concentration of blood parameters and change to BL (percentage):
percentage of change of Creatinin
Time frame: Day 14
Concentration of blood parameters and change to BL (absolute change):
absolute change of Creatinin
Time frame: Day 14
Neutrophil to lymphocyte ratio
Neutrophil to lymphocyte number ratio
Time frame: Day 4
Neutrophil to lymphocyte ratio
Neutrophil to lymphocyte number ratio
Time frame: Day 7
Neutrophil to lymphocyte ratio
Neutrophil to lymphocyte number ratio
Time frame: Day 14
IL-6/IL-10 ratio
IL-6/IL-10 concentration ratio
Time frame: Day 4
IL-6/IL-10 ratio
IL-6/IL-10 concentration ratio
Time frame: Day 7
IL-6/IL-10 ratio
IL-6/IL-10 concentration ratio
Time frame: Day 14
IL-6/INFy ratio
IL-6/INFy concentration ratio
Time frame: Day 14
IL-6/INFy ratio
IL-6/INFy concentration ratio
Time frame: Day 7
IL-6/INFy ratio
IL-6/INFy concentration ratio
Time frame: Day 4
Assessment of symptom improvement/worsening
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 4
Assessment of symptom improvement/worsening
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 7
Assessment of symptom improvement/worsening
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 14
Assessment of symptom improvement/worsening
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 28
Assessment of number of symptoms
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 4
Assessment of number of symptoms
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 7
Assessment of number of symptoms
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 14
Assessment of number of symptoms
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 28
Assessment of symptom distribution
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 4
Assessment of symptom distribution
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 7
Assessment of symptom distribution
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 14
Assessment of symptom distribution
FDA (Federal drug agency) recommended symptom questionnaire - higher scores describe worse symptoms, scoring 0 to 3 (question 1 to 12) and 0 to 2 (question 13 and 14)
Time frame: Day 28
Assessment of defervescence
Time to defervescence in days
Time frame: Day 28
Assessment of defervescence - number of patients
Number of patients who achieved defervescence
Time frame: Day 28
Assessment of defervescence - portion of patients
Proportion of patients who achieved defervescence
Time frame: Day 28
Assessment of defervescence
Absolute temperature values and change to BL
Time frame: Day 4
Assessment of defervescence
Absolute temperature values and change to BL
Time frame: Day 7
Assessment of defervescence
Absolute temperature values and change to BL
Time frame: Day 14
Assessment of defervescence
Absolute temperature values and change to BL
Time frame: Day 28
Assessment of improvement or absence of coughing
Time to cough reported as mild oder non existent in days
Time frame: Day 28
Assessment of improvement or absence of coughing
Time to non-existent coughing for all patients in days
Time frame: Day 28
Assessment of improvement or absence of coughing - proportion of patients
proportion of patients with moderate or severe cough at BL who achieved cough reported as mild or none existent
Time frame: Day 28
Assessment of improvement or absence of coughing - number of patients
Number of patients with moderate or severe cough at BL who achieved cough reported as mild or none existent
Time frame: Day 28
Assessment of improvement or absence of coughing
proportion of patients who achieved cough reported as none existent
Time frame: Day 28
Assessment of intensity and distribution of most bothersome symptom
Intensity of most bothersome symptom assessment done by visual analogue scale (VAS) and change to Baseline - score 0 to 10 cm, higher values describe higher intensity
Time frame: Day 28
Assessment of intensity and distribution of most bothersome symptom
Most bothersome symptom distribution (i.e.,number and percentage of patients with each symptom) (the most bothersome symptom will be defined by the patient at BL) assessment done by visual analogue scale (VAS) - score 0 to 10 cm, higher values describe higher intensity
Time frame: Day 28
Proportion of patients who return to usual health
proportion of patients who return to usual health
Time frame: Day 28
Number of patients who return to usual health
Number of patients who return to usual health
Time frame: Day 28
proportion of patients who return to usual activity
proportion of patients who return to usual activity
Time frame: Day 28
Requirement of hospitalisation or oxygen supplementation
Number of patients requiring hospitalisation or oxygen supplementation (patient reported)
Time frame: Day 28
Requirement of hospitalisation or oxygen supplementation
proportion of patients requiring hospitalisation or oxygen supplementation (patient reported)
Time frame: Day 28
Disease progression/improvement
Number of patients with improved or progressed disease state (according to world health organisation (WHO) scale) - Score 0 - 10, higher score described more progressed state
Time frame: Day 4
Disease progression/improvement
proportion of patients with improved or progressed disease state (according to world health organisation (WHO) scale) - Score 0 - 10, higher score described more progressed state
Time frame: Day 4
Disease progression/improvement
Number of patients with improved or progressed disease state (according to world health organisation (WHO) scale) Score 0 - 10, higher score described more progressed state
Time frame: Day 7
Disease progression/improvement
proportion of patients with improved or progressed disease state (according to world health organisation (WHO) scale) Score 0 - 10, higher score described more progressed state
Time frame: Day 7
Disease progression/improvement
Number of patients with improved or progressed disease state (according to world health organisation (WHO) scale) Score 0 - 10, higher score described more progressed state
Time frame: Day 14
Disease progression/improvement
proportion of patients with improved or progressed disease state (according to world health organisation (WHO) scale), Score 0 - 10, higher score described more progressed state
Time frame: Day 14
Disease progression/improvement
Number of patients with improved or progressed disease state (according to world health organisation (WHO) scale) Score 0 - 10, higher score described more progressed state
Time frame: Day 28
Disease progression/improvement
proportion of patients with improved or progressed disease state (according to world health organisation (WHO) scale) Score 0 - 10, higher score described more progressed state
Time frame: Day 28
Disease progression/improvement
Number of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 4
Disease progression/improvement
proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 4
Disease progression/improvement
Number of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 7
Disease progression/improvement
proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 7
Disease progression/improvement
Number of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 14
Disease progression/improvement
proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 14
Disease progression/improvement
Number of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 28
Disease progression/improvement
proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 28
Disease progression/improvement
WHO score and change to BL Score 0 - 10, higher score described more progressed state
Time frame: Day 4
Disease progression/improvement
WHO score and change to BL Score 0 - 10, higher score described more progressed state
Time frame: Day 7
Disease progression/improvement
WHO score and change to BL Score 0 - 10, higher score described more progressed state
Time frame: Day 14
Disease progression/improvement
WHO score and change to BL Score 0 - 10, higher score described more progressed state
Time frame: Day 28
Disease progression/improvement
Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 4
Disease progression/improvement
proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 4
Disease progression/improvement
Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 7
Disease progression/improvement
proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 7
Disease progression/improvement
proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 14
Disease progression/improvement
Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 14
Disease progression/improvement
proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 28
Disease progression/improvement
Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state
Time frame: Day 28
Assessment of oxygen saturation
Oxygen saturation measured by finger clip and change to BL
Time frame: Day 4
Assessment of oxygen saturation
Oxygen saturation measured by finger clip and change to BL
Time frame: Day 7
Assessment of oxygen saturation
Oxygen saturation measured by finger clip and change to BL
Time frame: Day 14
Assessment of oxygen saturation
Oxygen saturation measured by finger clip and change to BL
Time frame: Day 28
Assessment of intake of concomitant medication
Type and average daily dose of concomitant medication and total dose of paracetamol
Time frame: Day 14
Assessment of intake of concomitant medication
Average days of additional intake of concomitant medication paracetamol
Time frame: Day 4
Assessment of intake of concomitant medication
Average days of additional intake of concomitant medication paracetamol
Time frame: Day 7
Assessment of intake of concomitant medication
Average days of additional intake of concomitant medication paracetamol
Time frame: Day 14
Assessment of intake of concomitant medication
Average days of additional intake of concomitant medication paracetamol
Time frame: Day 28
Assessment of intake of concomitant medication
Number of patients with a reduction in concomitant medication intake
Time frame: Day 14
Assessment of intake of concomitant medication
proportion of patients with a reduction in concomitant medication intake
Time frame: Day 14
Number of patients with hyposmia or anosmia
Number of patients with hyposmia or anosmia
Time frame: Day 4
proportion of patients with hyposmia or anosmia
proportion of patients with hyposmia or anosmia
Time frame: Day 4
Number of patients with hyposmia or anosmia
Number of patients with hyposmia or anosmia
Time frame: Day 7
proportion of patients with hyposmia or anosmia
proportion of patients with hyposmia or anosmia
Time frame: Day 7
Number of patients with hyposmia or anosmia
Number of patients with hyposmia or anosmia
Time frame: Day 14
proportion of patients with hyposmia or anosmia
proportion of patients with hyposmia or anosmia
Time frame: Day 14
Number of patients with hyposmia or anosmia
Number of patients with hyposmia or anosmia
Time frame: Day 28
proportion of patients with hyposmia or anosmia
proportion of patients with hyposmia or anosmia
Time frame: Day 28
Number of patients with fever
Number of patients with fever
Time frame: Day 4
proportion of patients with fever
proportion of patients with fever
Time frame: Day 4
Number of patients with fever
Number of patients with fever
Time frame: Day 7
proportion of patients with fever
proportion of patients with fever
Time frame: Day 7
Number of patients with fever
Number of patients with fever
Time frame: Day 14
proportion of patients with fever
proportion of patients with fever
Time frame: Day 14
Number of patients with fever
Number of patients with fever
Time frame: Day 28
proportion of patients with fever
proportion of patients with fever
Time frame: Day 28
Number of patients with COVID-19 vaccination
Number of patients with COVID-19 vaccination
Time frame: Day 4
proportions of patients with COVID-19 vaccination
proportions of patients with COVID-19 vaccination
Time frame: Day 4
Number of patients with COVID-19 vaccination
Number of patients with COVID-19 vaccination
Time frame: Day 7
proportions of patients with COVID-19 vaccination
proportions of patients with COVID-19 vaccination
Time frame: Day 7
Number of patients with COVID-19 vaccination
Number of patients with COVID-19 vaccination
Time frame: Day 14
proportions of patients with COVID-19 vaccination
proportions of patients with COVID-19 vaccination
Time frame: Day 14
Number of patients with COVID-19 vaccination
Number of patients with COVID-19 vaccination
Time frame: Day 28
proportions of patients with COVID-19 vaccination
proportions of patients with COVID-19 vaccination
Time frame: Day 28
Number of recovered COVID-19 patients
Number of recovered COVID-19 patients
Time frame: Day 4
proportion of recovered COVID-19 patients
proportion of recovered COVID-19 patients
Time frame: Day 4
Number of recovered COVID-19 patients
Number of recovered COVID-19 patients
Time frame: Day 7
proportion of recovered COVID-19 patients
proportion of recovered COVID-19 patients
Time frame: Day 7
Number of recovered COVID-19 patients
Number of recovered COVID-19 patients
Time frame: Day 14
proportion of recovered COVID-19 patients
proportion of recovered COVID-19 patients
Time frame: Day 14
Number of recovered COVID-19 patients
Number of recovered COVID-19 patients
Time frame: Day 28
proportion of recovered COVID-19 patients
proportion of recovered COVID-19 patients
Time frame: Day 28
Assessment of severe acute respiratory syndrome (SARS)- Corona virus (CoV) -2 negativity
Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)
Time frame: Day 4
Assessment of SARS-CoV-2 negativity
Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)
Time frame: Day 7
Assessment of SARS-CoV-2 negativity
Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)
Time frame: Day 14
Assessment of SARS-CoV-2 negativity
Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)
Time frame: Day 28
Assessment of compliance
Compliance to investigational medicinal product (IMP) by dose taken and as documented in patient diary
Time frame: Day 4
Assessment of compliance
Compliance to IMP by dose taken and as documented in patient diary
Time frame: Day 7
Assessment of compliance
Compliance to IMP by dose taken and as documented in patient diary
Time frame: Day 14
Number of adverse events (AE)
Number of adverse events (AE)
Time frame: through study completion, average 28 days
Number of serious adverse events (SAE)
Number of serious adverse events (SAE)
Time frame: through study completion, average 28 days
Type and severity of adverse events
Type and severity of adverse events
Time frame: through study completion, average 28 days
Type and severity of serious adverse events
Type and severity of serious adverse events
Time frame: through study completion, average 28 days
Seriousness and relatedness of AEs
Seriousness and relatedness of AEs
Time frame: through study completion, average 28 days
Seriousness and relatedness of SAEs
Seriousness and relatedness of SAEs
Time frame: through study completion, average 28 days