Skip to main content
OpenTrials
Completed

NCT Number: NCT05276375

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fraunhofer ITMP - early clinical development

Frankfurt, Hessia, 60596, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Current participation in another interventional clinical trial

Treatment and study plan

Bronchipret

Drug

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

Primary outcomes

  1. Change in average concentration of immunologic markers

    Time frame: Comparison Baseline to day 7

    concentration of Interleukin 2 (IL-2)

  2. Change in average concentration of immunologic markers - IL4

    Time frame: Comparison Baseline to day 7

    concentration of Interleukin (IL) 4

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

    Time frame: Comparison Baseline to day 7

    concentration of IL-6

  4. Change in average concentration of immunologic markers - IL-8

    Time frame: Comparison Baseline to day 7

    concentration of IL-8

  5. Change in average concentration of immunologic markers - IL-10

    Time frame: Comparison Baseline to day 7

    concentration of IL-10

  6. Change in average concentration of immunologic markers - Interferon y

    Time frame: Comparison Baseline to day 7

    concentration of interferon (INF) y

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

    Time frame: Comparison Baseline to day 7

    concentration of c-reactive protein (CRP)

  8. Change in average concentration of immunologic markers - IL-1β

    Time frame: Comparison Baseline to day 7

    concentration of IL-1β

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

    Time frame: Comparison Baseline to day 7

    concentration of INFα

  10. Change in average concentration of immunologic markers - TNFα

    Time frame: Comparison Baseline to day 7

    concentration of tumor necrosis factor alpha (TNFα)

  11. Change in average number of immunologic markers - neutrophils

    Time frame: Comparison Baseline to day 7

    number of neutrophils

  12. Change in average number of immunologic markers - lymphocytes

    Time frame: Comparison Baseline to day 7

    number of lymphocytes

  13. Change in average number of immunologic markers - monocytes

    Time frame: Comparison Baseline to day 7

    number of monocytes

  14. Change in average number of immunologic markers - eosinophils

    Time frame: Comparison Baseline to day 7

    number of eosinophils

  15. Change in average number of immunologic markers - basophils

    Time frame: Comparison Baseline to day 7

    number of basophils

  16. Change in average number of immunologic markers - platelets

    Time frame: Comparison Baseline to day 7

    number of platelets

Secondary outcomes

  1. Concentration of blood parameters and change to BL - IL2

    Time frame: Day 4

    percentage of change of concentration of IL-2

  2. Concentration of blood parameters and change to BL

    Time frame: Day 4

    absolute change of concentration of IL-2

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

    Time frame: Day 7

    percentage of change of concentration of IL-2

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

    Time frame: Day 7

    absolute change of concentration of IL-2

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

    Time frame: Day 14

    absolute change of concentration of IL-2

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

    Time frame: Day 14

    percentage of change of concentration of IL-2

  7. Concentration of blood parameters and change to BL (percentage) IL4

    Time frame: Day 4

    percentage of change of concentration of IL-4

  8. Concentration of blood parameters and change to BL (absolute change): IL4

    Time frame: Day 7

    absolute change of concentration of IL-4

  9. Concentration of blood parameters and change to BL (percentage) IL4

    Time frame: Day 7

    percentage of change of concentration of IL-4

  10. Concentration of blood parameters and change to BL (absolute change) IL4

    Time frame: Day 14

    absolute change of concentration of IL-4

  11. Concentration of blood parameters and change to BL (percentage) IL4

    Time frame: Day 14

    percentage of change of concentration of IL-4

  12. Concentration of blood parameters and change to BL (absolute change) IL6

    Time frame: Day 4

    absolute change of concentration of IL-6

  13. Concentration of blood parameters and change to BL (percentage) IL6

    Time frame: Day 4

    percentage of change of concentration of IL-6

  14. Concentration of blood parameters and change to BL (absolute change) IL6

    Time frame: Day 7

    absolute change of concentration of IL-6

  15. Concentration of blood parameters and change to BL (percentage) IL6

    Time frame: Day 7

    percentage of change of concentration of IL-6

  16. Concentration of blood parameters and change to BL (percentage) IL6

    Time frame: Day 14

    percentage of change of concentration of IL-6

  17. Concentration of blood parameters and change to BL (absolute change) IL6

    Time frame: Day 14

    absolute change of concentration of IL-6

  18. Concentration of blood parameters and change to BL (percentage) IL8

    Time frame: Day 4

    percentage of change of concentration of IL-8

  19. Concentration of blood parameters and change to BL (absolute change) IL8

    Time frame: Day 4

    absolute change of concentration of IL-8

  20. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of concentration of IL-8

  21. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of concentration of IL-8

  22. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of concentration of IL-8

  23. Concentration of blood parameters and change to BL (absolute change IL8):

    Time frame: Day 14

    absolute change of concentration of IL-8

  24. Concentration of blood parameters and change to BL (absolute change IL10):

    Time frame: Day 4

    absolute change of concentration of IL-10

  25. Concentration of blood parameters and change to BL (IL10 percentage):

    Time frame: Day 4

    percentage of change of concentration of IL-10

  26. Concentration of blood parameters and change to BL (absolute change IL10):

    Time frame: Day 7

    absolute change of concentration of IL-10

  27. Concentration of blood parameters and change to BL (percentage): IL10

    Time frame: Day 7

    percentage of change of concentration of IL-10

  28. Concentration of blood parameters and change to BL (absolute change IL10):

    Time frame: Day 14

    absolute change of concentration of IL-10

  29. Concentration of blood parameters and change to BL (percentage): IL10

    Time frame: Day 14

    percentage of change of concentration of IL-10

  30. Concentration of blood parameters and change to BL (INFy percentage):

    Time frame: Day 4

    percentage of change of concentration of INFy

  31. Concentration of blood parameters and change to BL (absolute change INFy):

    Time frame: Day 4

    absolute change of concentration of INFy

  32. Concentration of blood parameters and change to BL (percentage): INFy

    Time frame: Day 7

    percentage of change of concentration of INFy

  33. Concentration of blood parameters and change to BL (absolute change): INFy

    Time frame: Day 7

    absolute change of concentration of INFy

  34. Concentration of blood parameters and change to BL (percentage): INFy

    Time frame: Day 14

    percentage of change of concentration of INFy

  35. Concentration of blood parameters and change to BL (absolute change): INFy

    Time frame: Day 14

    absolute change of concentration of INFy

  36. Concentration of blood parameters and change to BL (absolute change): CRP

    Time frame: Day 4

    absolute change of concentration of CRP

  37. Concentration of blood parameters and change to BL (percentage): CRP

    Time frame: Day 4

    percentage of change of concentration of CRP

  38. Concentration of blood parameters and change to BL (absolute change): CRP

    Time frame: Day 7

    absolute change of concentration of CRP

  39. Concentration of blood parameters and change to BL (percentage): CRP

    Time frame: Day 7

    percentage of change of concentration of CRP

  40. Concentration of blood parameters and change to BL (absolute change): CRP

    Time frame: Day 14

    absolute change of concentration of CRP

  41. Concentration of blood parameters and change to BL (percentage): CRP

    Time frame: Day 14

    percentage of change of concentration of CRP

  42. Concentration of blood parameters and change to BL (percentage): IL-1β

    Time frame: Day 4

    percentage of change of concentration of IL-1β

  43. Concentration of blood parameters and change to BL (absolute change): IL-1β

    Time frame: Day 4

    absolute change of concentration of IL-1β

  44. Concentration of blood parameters and change to BL (percentage): IL-1β

    Time frame: Day 7

    percentage of change of concentration of IL-1β

  45. Concentration of blood parameters and change to BL (absolute change): IL-1β

    Time frame: Day 7

    absolute change of concentration of IL-1β

  46. Concentration of blood parameters and change to BL (percentage): IL-1β

    Time frame: Day 14

    percentage of change of concentration of IL-1β

  47. Concentration of blood parameters and change to BL (absolute change): IL-1β

    Time frame: Day 14

    absolute change of concentration of IL-1β

  48. Concentration of blood parameters and change to BL (absolute change): INFα

    Time frame: Day 4

    absolute change of concentration of INFα

  49. Concentration of blood parameters and change to BL (percentage): INFα

    Time frame: Day 4

    percentage of change of concentration of INFα

  50. Concentration of blood parameters and change to BL (absolute change):INFα

    Time frame: Day 7

    absolute change of concentration of INFα

  51. Concentration of blood parameters and change to BL (percentage): INFα

    Time frame: Day 7

    percentage of change of concentration of INFα

  52. Concentration of blood parameters and change to BL (percentage): INFα

    Time frame: Day 14

    percentage of change of concentration of INFα

  53. Concentration of blood parameters and change to BL (absolute change): INFα

    Time frame: Day 14

    absolute change of concentration of INFα

  54. Concentration of blood parameters and change to BL (absolute change): TNFα,

    Time frame: Day 4

    absolute change of concentration of TNFα,

  55. Concentration of blood parameters and change to BL (percentage): TNFα,

    Time frame: Day 4

    percentage of change of concentration of TNFα,

  56. Concentration of blood parameters and change to BL (absolute change): TNFα,

    Time frame: Day 7

    absolute change of concentration of TNFα,

  57. Concentration of blood parameters and change to BL (percentage): TNFα,

    Time frame: Day 7

    percentage of concentration of TNFα,

  58. Concentration of blood parameters and change to BL (absolute change): TNFα,

    Time frame: Day 14

    absolute change of concentration of TNFα,

  59. Concentration of blood parameters and change to BL (percentage): TNFα,

    Time frame: Day 14

    percentage of change of concentration of TNFα,

  60. Concentration of blood parameters and change to BL (percentage): neutrophils

    Time frame: Day 4

    percentage change of neutrophils

  61. Concentration of blood parameters and change to BL (absolute change): neutrophils

    Time frame: Day 4

    absolute change of neutrophils number

  62. Concentration of blood parameters and change to BL (percentage): neutrophils

    Time frame: Day 7

    percentage change of neutrophils

  63. Concentration of blood parameters and change to BL (absolute change): neutrophils

    Time frame: Day 7

    absolute change of neutrophils number

  64. Concentration of blood parameters and change to BL (percentage): neutrophils

    Time frame: Day 14

    percentage change of neutrophils

  65. Concentration of blood parameters and change to BL (absolute change): neutrophils

    Time frame: Day 14

    absolute change of neutrophils number

  66. Concentration of blood parameters and change to BL (absolute change): lymphocytes

    Time frame: Day 4

    absolute change of lymphocytes number

  67. Concentration of blood parameters and change to BL (percentage): lymphocytes

    Time frame: Day 4

    percentage change of lymphocytes

  68. Concentration of blood parameters and change to BL (absolute change): lymphocytes

    Time frame: Day 7

    absolute change of lymphocytes number

  69. Concentration of blood parameters and change to BL (percentage): lymphocytes

    Time frame: Day 7

    percentage change of lymphocytes

  70. Concentration of blood parameters and change to BL (absolute change): lymphocytes

    Time frame: Day 14

    absolute change of lymphocytes number

  71. Concentration of blood parameters and change to BL (percentage): lymphocytes

    Time frame: Day 14

    percentage change of lymphocytes

  72. Concentration of blood parameters and change to BL (percentage): monocytes

    Time frame: Day 4

    percentage change of monocytes

  73. Concentration of blood parameters and change to BL (absolute change): monocytes

    Time frame: Day 4

    absolute change of monocytes number

  74. Concentration of blood parameters and change to BL (percentage): monocytes

    Time frame: Day 7

    percentage change of monocytes

  75. Concentration of blood parameters and change to BL (absolute change): monocytes

    Time frame: Day 7

    absolute change of monocytes number

  76. Concentration of blood parameters and change to BL (percentage): monocytes

    Time frame: Day 14

    percentage of change of monocytes

  77. Concentration of blood parameters and change to BL (absolute change): monocytes

    Time frame: Day 14

    absolute change of monocytes number

  78. Concentration of blood parameters and change to BL (absolute change): eosinophils

    Time frame: Day 4

    absolute change of eosinophils number

  79. Concentration of blood parameters and change to BL (percentage): eosinophils

    Time frame: Day 4

    percentage of change of eosinophils

  80. Concentration of blood parameters and change to BL (percentage): eosinophils

    Time frame: Day 7

    percentage of change of eosinophils

  81. Concentration of blood parameters and change to BL (absolute change): eosinophils

    Time frame: Day 7

    absolute change of eosinophils number

  82. Concentration of blood parameters and change to BL (percentage): eosinophils

    Time frame: Day 14

    percentage of change of eosinophils

  83. Concentration of blood parameters and change to BL (absolute change): eosinophils

    Time frame: Day 14

    absolute change of eosinophils number

  84. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of basophils number

  85. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of basophils number

  86. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of basophils number

  87. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of basophils

  88. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of basophils number

  89. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of basophils

  90. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of platelets

  91. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of platelet number

  92. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of platelets

  93. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of platelet number

  94. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of platelets

  95. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of platelet number

  96. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of lactate dehydrogenase (LDH)

  97. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of lactate dehydrogenase (LDH)

  98. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of LDH

  99. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of LDH

  100. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of LDH

  101. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of LDH

  102. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of ferritin

  103. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of ferritin

  104. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of ferritin

  105. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of ferritin

  106. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of ferritin

  107. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of ferritin

  108. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of haemoglobin

  109. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of haemoglobin

  110. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of haemoglobin

  111. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of haemoglobin

  112. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of haemoglobin

  113. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of haemoglobin

  114. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of alanine aminotransferase (ALT)

  115. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of alanine aminotransferase (ALT)

  116. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of alanine aminotransferase (ALT)

  117. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of alanine aminotransferase (ALT)

  118. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of alanine aminotransferase (ALT)

  119. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of alanine aminotransferase (ALT)

  120. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of Aspartate aminotransferase (AST)

  121. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of Aspartate aminotransferase (AST)

  122. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of Aspartate aminotransferase (AST)

  123. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of Aspartate aminotransferase (AST)

  124. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of Aspartate aminotransferase (AST)

  125. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of activated partial thromboplastin time

  126. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of activated partial thromboplastin time

  127. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of activated partial thromboplastin time

  128. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of activated partial thromboplastin time

  129. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of activated partial thromboplastin time

  130. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of activated partial thromboplastin time

  131. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of prothrombin Z

  132. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of prothrombin Z

  133. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of prothrombin Z

  134. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of prothrombin Z

  135. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of prothrombin Z

  136. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of prothrombin Z

  137. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of fibrinogen

  138. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of fibrinogen

  139. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of fibrinogen

  140. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of fibrinogen

  141. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of fibrinogen

  142. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of fibrinogen

  143. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of d-dimeric

  144. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of d-dimeric

  145. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of d-dimeric

  146. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of d-dimeric

  147. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of d-dimeric

  148. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of d-dimeric

  149. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of fibrin-degranulation products

  150. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of fibrin-degranulation products

  151. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of fibrin-degranulation products

  152. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of fibrin-degranulation products

  153. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of fibrin-degranulation products

  154. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of fibrin-degranulation products

  155. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of anti-thrombin III activity

  156. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of anti-thrombin III activity

  157. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of anti-thrombin III activity

  158. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of anti-thrombin III activity

  159. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of anti-thrombin III activity

  160. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of anti-thrombin III activity

  161. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of Immunglobulin M (IgM)

  162. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of Immunglobulin M (IgM)

  163. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of Immunglobulin M (IgM)

  164. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of Immunglobulin M (IgM)

  165. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of Immunglobulin M (IgM)

  166. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of Immunglobulin M (IgM)

  167. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of Immunglobulin G (IgG)

  168. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of Immunglobulin G (IgG)

  169. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of Immunglobulin G (IgG)

  170. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of Immunglobulin G (IgG)

  171. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of Immunglobulin G (IgG)

  172. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of Immunglobulin G (IgG)

  173. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 4

    percentage of change of Creatinin

  174. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 4

    absolute change of Creatinin

  175. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 7

    percentage of change of Creatinin

  176. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 7

    absolute change of Creatinin

  177. Concentration of blood parameters and change to BL (percentage):

    Time frame: Day 14

    percentage of change of Creatinin

  178. Concentration of blood parameters and change to BL (absolute change):

    Time frame: Day 14

    absolute change of Creatinin

  179. Neutrophil to lymphocyte ratio

    Time frame: Day 4

    Neutrophil to lymphocyte number ratio

  180. Neutrophil to lymphocyte ratio

    Time frame: Day 7

    Neutrophil to lymphocyte number ratio

  181. Neutrophil to lymphocyte ratio

    Time frame: Day 14

    Neutrophil to lymphocyte number ratio

  182. IL-6/IL-10 ratio

    Time frame: Day 4

    IL-6/IL-10 concentration ratio

  183. IL-6/IL-10 ratio

    Time frame: Day 7

    IL-6/IL-10 concentration ratio

  184. IL-6/IL-10 ratio

    Time frame: Day 14

    IL-6/IL-10 concentration ratio

  185. IL-6/INFy ratio

    Time frame: Day 14

    IL-6/INFy concentration ratio

  186. IL-6/INFy ratio

    Time frame: Day 7

    IL-6/INFy concentration ratio

  187. IL-6/INFy ratio

    Time frame: Day 4

    IL-6/INFy concentration ratio

  188. Assessment of symptom improvement/worsening

    Time frame: Day 4

    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)

  189. Assessment of symptom improvement/worsening

    Time frame: Day 7

    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)

  190. Assessment of symptom improvement/worsening

    Time frame: Day 14

    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)

  191. Assessment of symptom improvement/worsening

    Time frame: Day 28

    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)

  192. Assessment of number of symptoms

    Time frame: Day 4

    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)

  193. Assessment of number of symptoms

    Time frame: Day 7

    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)

  194. Assessment of number of symptoms

    Time frame: Day 14

    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)

  195. Assessment of number of symptoms

    Time frame: Day 28

    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)

  196. Assessment of symptom distribution

    Time frame: Day 4

    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)

  197. Assessment of symptom distribution

    Time frame: Day 7

    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)

  198. Assessment of symptom distribution

    Time frame: Day 14

    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)

  199. Assessment of symptom distribution

    Time frame: Day 28

    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)

  200. Assessment of defervescence

    Time frame: Day 28

    Time to defervescence in days

  201. Assessment of defervescence - number of patients

    Time frame: Day 28

    Number of patients who achieved defervescence

  202. Assessment of defervescence - portion of patients

    Time frame: Day 28

    Proportion of patients who achieved defervescence

  203. Assessment of defervescence

    Time frame: Day 4

    Absolute temperature values and change to BL

  204. Assessment of defervescence

    Time frame: Day 7

    Absolute temperature values and change to BL

  205. Assessment of defervescence

    Time frame: Day 14

    Absolute temperature values and change to BL

  206. Assessment of defervescence

    Time frame: Day 28

    Absolute temperature values and change to BL

  207. Assessment of improvement or absence of coughing

    Time frame: Day 28

    Time to cough reported as mild oder non existent in days

  208. Assessment of improvement or absence of coughing

    Time frame: Day 28

    Time to non-existent coughing for all patients in days

  209. Assessment of improvement or absence of coughing - proportion of patients

    Time frame: Day 28

    proportion of patients with moderate or severe cough at BL who achieved cough reported as mild or none existent

  210. Assessment of improvement or absence of coughing - number of patients

    Time frame: Day 28

    Number of patients with moderate or severe cough at BL who achieved cough reported as mild or none existent

  211. Assessment of improvement or absence of coughing

    Time frame: Day 28

    proportion of patients who achieved cough reported as none existent

  212. Assessment of intensity and distribution of most bothersome symptom

    Time frame: Day 28

    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

  213. Assessment of intensity and distribution of most bothersome symptom

    Time frame: Day 28

    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

  214. Proportion of patients who return to usual health

    Time frame: Day 28

    proportion of patients who return to usual health

  215. Number of patients who return to usual health

    Time frame: Day 28

    Number of patients who return to usual health

  216. proportion of patients who return to usual activity

    Time frame: Day 28

    proportion of patients who return to usual activity

  217. Requirement of hospitalisation or oxygen supplementation

    Time frame: Day 28

    Number of patients requiring hospitalisation or oxygen supplementation (patient reported)

  218. Requirement of hospitalisation or oxygen supplementation

    Time frame: Day 28

    proportion of patients requiring hospitalisation or oxygen supplementation (patient reported)

  219. Disease progression/improvement

    Time frame: Day 4

    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

  220. Disease progression/improvement

    Time frame: Day 4

    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

  221. Disease progression/improvement

    Time frame: Day 7

    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

  222. Disease progression/improvement

    Time frame: Day 7

    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

  223. Disease progression/improvement

    Time frame: Day 14

    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

  224. Disease progression/improvement

    Time frame: Day 14

    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

  225. Disease progression/improvement

    Time frame: Day 28

    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

  226. Disease progression/improvement

    Time frame: Day 28

    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

  227. Disease progression/improvement

    Time frame: Day 4

    Number of patients with each WHO score Score 0 - 10, higher score described more progressed state

  228. Disease progression/improvement

    Time frame: Day 4

    proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state

  229. Disease progression/improvement

    Time frame: Day 7

    Number of patients with each WHO score Score 0 - 10, higher score described more progressed state

  230. Disease progression/improvement

    Time frame: Day 7

    proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state

  231. Disease progression/improvement

    Time frame: Day 14

    Number of patients with each WHO score Score 0 - 10, higher score described more progressed state

  232. Disease progression/improvement

    Time frame: Day 14

    proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state

  233. Disease progression/improvement

    Time frame: Day 28

    Number of patients with each WHO score Score 0 - 10, higher score described more progressed state

  234. Disease progression/improvement

    Time frame: Day 28

    proportion of patients with each WHO score Score 0 - 10, higher score described more progressed state

  235. Disease progression/improvement

    Time frame: Day 4

    WHO score and change to BL Score 0 - 10, higher score described more progressed state

  236. Disease progression/improvement

    Time frame: Day 7

    WHO score and change to BL Score 0 - 10, higher score described more progressed state

  237. Disease progression/improvement

    Time frame: Day 14

    WHO score and change to BL Score 0 - 10, higher score described more progressed state

  238. Disease progression/improvement

    Time frame: Day 28

    WHO score and change to BL Score 0 - 10, higher score described more progressed state

  239. Disease progression/improvement

    Time frame: Day 4

    Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  240. Disease progression/improvement

    Time frame: Day 4

    proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  241. Disease progression/improvement

    Time frame: Day 7

    Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  242. Disease progression/improvement

    Time frame: Day 7

    proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  243. Disease progression/improvement

    Time frame: Day 14

    proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  244. Disease progression/improvement

    Time frame: Day 14

    Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  245. Disease progression/improvement

    Time frame: Day 28

    proportion of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  246. Disease progression/improvement

    Time frame: Day 28

    Number of patients in each disease severity state according to WHO score Score 0 - 10, higher score described more progressed state

  247. Assessment of oxygen saturation

    Time frame: Day 4

    Oxygen saturation measured by finger clip and change to BL

  248. Assessment of oxygen saturation

    Time frame: Day 7

    Oxygen saturation measured by finger clip and change to BL

  249. Assessment of oxygen saturation

    Time frame: Day 14

    Oxygen saturation measured by finger clip and change to BL

  250. Assessment of oxygen saturation

    Time frame: Day 28

    Oxygen saturation measured by finger clip and change to BL

  251. Assessment of intake of concomitant medication

    Time frame: Day 14

    Type and average daily dose of concomitant medication and total dose of paracetamol

  252. Assessment of intake of concomitant medication

    Time frame: Day 4

    Average days of additional intake of concomitant medication paracetamol

  253. Assessment of intake of concomitant medication

    Time frame: Day 7

    Average days of additional intake of concomitant medication paracetamol

  254. Assessment of intake of concomitant medication

    Time frame: Day 14

    Average days of additional intake of concomitant medication paracetamol

  255. Assessment of intake of concomitant medication

    Time frame: Day 28

    Average days of additional intake of concomitant medication paracetamol

  256. Assessment of intake of concomitant medication

    Time frame: Day 14

    Number of patients with a reduction in concomitant medication intake

  257. Assessment of intake of concomitant medication

    Time frame: Day 14

    proportion of patients with a reduction in concomitant medication intake

  258. Number of patients with hyposmia or anosmia

    Time frame: Day 4

    Number of patients with hyposmia or anosmia

  259. proportion of patients with hyposmia or anosmia

    Time frame: Day 4

    proportion of patients with hyposmia or anosmia

  260. Number of patients with hyposmia or anosmia

    Time frame: Day 7

    Number of patients with hyposmia or anosmia

  261. proportion of patients with hyposmia or anosmia

    Time frame: Day 7

    proportion of patients with hyposmia or anosmia

  262. Number of patients with hyposmia or anosmia

    Time frame: Day 14

    Number of patients with hyposmia or anosmia

  263. proportion of patients with hyposmia or anosmia

    Time frame: Day 14

    proportion of patients with hyposmia or anosmia

  264. Number of patients with hyposmia or anosmia

    Time frame: Day 28

    Number of patients with hyposmia or anosmia

  265. proportion of patients with hyposmia or anosmia

    Time frame: Day 28

    proportion of patients with hyposmia or anosmia

  266. Number of patients with fever

    Time frame: Day 4

    Number of patients with fever

  267. proportion of patients with fever

    Time frame: Day 4

    proportion of patients with fever

  268. Number of patients with fever

    Time frame: Day 7

    Number of patients with fever

  269. proportion of patients with fever

    Time frame: Day 7

    proportion of patients with fever

  270. Number of patients with fever

    Time frame: Day 14

    Number of patients with fever

  271. proportion of patients with fever

    Time frame: Day 14

    proportion of patients with fever

  272. Number of patients with fever

    Time frame: Day 28

    Number of patients with fever

  273. proportion of patients with fever

    Time frame: Day 28

    proportion of patients with fever

  274. Number of patients with COVID-19 vaccination

    Time frame: Day 4

    Number of patients with COVID-19 vaccination

  275. proportions of patients with COVID-19 vaccination

    Time frame: Day 4

    proportions of patients with COVID-19 vaccination

  276. Number of patients with COVID-19 vaccination

    Time frame: Day 7

    Number of patients with COVID-19 vaccination

  277. proportions of patients with COVID-19 vaccination

    Time frame: Day 7

    proportions of patients with COVID-19 vaccination

  278. Number of patients with COVID-19 vaccination

    Time frame: Day 14

    Number of patients with COVID-19 vaccination

  279. proportions of patients with COVID-19 vaccination

    Time frame: Day 14

    proportions of patients with COVID-19 vaccination

  280. Number of patients with COVID-19 vaccination

    Time frame: Day 28

    Number of patients with COVID-19 vaccination

  281. proportions of patients with COVID-19 vaccination

    Time frame: Day 28

    proportions of patients with COVID-19 vaccination

  282. Number of recovered COVID-19 patients

    Time frame: Day 4

    Number of recovered COVID-19 patients

  283. proportion of recovered COVID-19 patients

    Time frame: Day 4

    proportion of recovered COVID-19 patients

  284. Number of recovered COVID-19 patients

    Time frame: Day 7

    Number of recovered COVID-19 patients

  285. proportion of recovered COVID-19 patients

    Time frame: Day 7

    proportion of recovered COVID-19 patients

  286. Number of recovered COVID-19 patients

    Time frame: Day 14

    Number of recovered COVID-19 patients

  287. proportion of recovered COVID-19 patients

    Time frame: Day 14

    proportion of recovered COVID-19 patients

  288. Number of recovered COVID-19 patients

    Time frame: Day 28

    Number of recovered COVID-19 patients

  289. proportion of recovered COVID-19 patients

    Time frame: Day 28

    proportion of recovered COVID-19 patients

  290. Assessment of severe acute respiratory syndrome (SARS)- Corona virus (CoV) -2 negativity

    Time frame: Day 4

    Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)

  291. Assessment of SARS-CoV-2 negativity

    Time frame: Day 7

    Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)

  292. Assessment of SARS-CoV-2 negativity

    Time frame: Day 14

    Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)

  293. Assessment of SARS-CoV-2 negativity

    Time frame: Day 28

    Assessment of SARS-CoV-2 negativity measured by polymerase chain reaction (PCR) test)

  294. Assessment of compliance

    Time frame: Day 4

    Compliance to investigational medicinal product (IMP) by dose taken and as documented in patient diary

  295. Assessment of compliance

    Time frame: Day 7

    Compliance to IMP by dose taken and as documented in patient diary

  296. Assessment of compliance

    Time frame: Day 14

    Compliance to IMP by dose taken and as documented in patient diary

  297. Number of adverse events (AE)

    Time frame: through study completion, average 28 days

    Number of adverse events (AE)

  298. Number of serious adverse events (SAE)

    Time frame: through study completion, average 28 days

    Number of serious adverse events (SAE)

  299. Type and severity of adverse events

    Time frame: through study completion, average 28 days

    Type and severity of adverse events

  300. Type and severity of serious adverse events

    Time frame: through study completion, average 28 days

    Type and severity of serious adverse events

  301. Seriousness and relatedness of AEs

    Time frame: through study completion, average 28 days

    Seriousness and relatedness of AEs

  302. Seriousness and relatedness of SAEs

    Time frame: through study completion, average 28 days

    Seriousness and relatedness of SAEs

Sponsors and collaborators

Lead sponsor

Dr. Frank Behrens

Other

Collaborators

  • Bionorica SE

Registry information

Official study title

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

Acronym: BroVID

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.