AzTrials
AzTrials

COVID-19Phase 2BroVIDNCT05276375

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

A Phase 2 study testing Bronchipret in people with COVID-19, run by Dr. Frank Behrens at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is currently an urgent need for effective and safe treatments of Coronavirus Disease (COVID) - 19 and the cytokine storm that is responsible for the development of patient's Acute Respiratory Distress Syndrome (ARDS). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
COVID-19
What is being tested?
Bronchipret
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteGermany
Study dates
14 Jan 2022to 30 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Fraunhofer ITMP - early clinical development

    Frankfurt, Hessia, 60596

Other trials in Germany

About this study

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

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.

Read the detailed description

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

As Bronchipret has been proven to be a very safe medicine, it is not expected that it would lead to the development of severe adverse effects in COVID-19 patients. Bronchipret can therefore be recommended as effective and safe supplementary treatments of COVID-19, even more so considering the positive effects shown in vitro. Thus, this randomized study will be conducted to assess the effect of Bronchipret on the immune response and recovery in patients with mild COVID-19 by assessing several blood parameters as well as the symptom recovery and improvement in comparison to patients who do not receive Bronchipret. Another aim of this feasibility study is to determine the best possible primary endpoint, i.e. which shows the greatest effect according to Cohen.

Conditions
COVID-19
Being tested
Bronchipret
Keywords
ARDS, COVID 19, Bronchipret
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BronchipretDrug

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

Study groups in NCT05276375
Study groupRoleWhat they receive
BronchipretActive comparatorBronchipret syrup (3x 5,4 ml daily, according to summary of product characteristics) until day 14
Receives: Drug: Bronchipret
standard of careNo interventionno study intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in average concentration of immunologic markers

    concentration of Interleukin 2 (IL-2)

    Measured: Comparison Baseline to day 7

  2. Change in average concentration of immunologic markers - IL4

    concentration of Interleukin (IL) 4

    Measured: Comparison Baseline to day 7

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

    concentration of IL-6

    Measured: Comparison Baseline to day 7

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

    concentration of IL-8

    Measured: Comparison Baseline to day 7

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

    concentration of IL-10

    Measured: Comparison Baseline to day 7

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

    concentration of interferon (INF) y

    Measured: Comparison Baseline to day 7

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

    concentration of c-reactive protein (CRP)

    Measured: Comparison Baseline to day 7

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

    concentration of IL-1β

    Measured: Comparison Baseline to day 7

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

    concentration of INFα

    Measured: Comparison Baseline to day 7

  10. Change in average concentration of immunologic markers - TNFα

    concentration of tumor necrosis factor alpha (TNFα)

    Measured: Comparison Baseline to day 7

  11. Change in average number of immunologic markers - neutrophils

    number of neutrophils

    Measured: Comparison Baseline to day 7

  12. Change in average number of immunologic markers - lymphocytes

    number of lymphocytes

    Measured: Comparison Baseline to day 7

  13. Change in average number of immunologic markers - monocytes

    number of monocytes

    Measured: Comparison Baseline to day 7

  14. Change in average number of immunologic markers - eosinophils

    number of eosinophils

    Measured: Comparison Baseline to day 7

  15. Change in average number of immunologic markers - basophils

    number of basophils

    Measured: Comparison Baseline to day 7

  16. Change in average number of immunologic markers - platelets

    number of platelets

    Measured: Comparison Baseline to day 7

Secondary outcomes (302)

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

    percentage of change of concentration of IL-2

    Measured: Day 4

  2. Concentration of blood parameters and change to BL

    absolute change of concentration of IL-2

    Measured: Day 4

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

    percentage of change of concentration of IL-2

    Measured: Day 7

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

    absolute change of concentration of IL-2

    Measured: Day 7

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

    absolute change of concentration of IL-2

    Measured: Day 14

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

    percentage of change of concentration of IL-2

    Measured: Day 14

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

    percentage of change of concentration of IL-4

    Measured: Day 4

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

    absolute change of concentration of IL-4

    Measured: Day 7

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

    percentage of change of concentration of IL-4

    Measured: Day 7

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

    absolute change of concentration of IL-4

    Measured: Day 14

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

    percentage of change of concentration of IL-4

    Measured: Day 14

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

    absolute change of concentration of IL-6

    Measured: Day 4

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

    percentage of change of concentration of IL-6

    Measured: Day 4

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

    absolute change of concentration of IL-6

    Measured: Day 7

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

    percentage of change of concentration of IL-6

    Measured: Day 7

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

    percentage of change of concentration of IL-6

    Measured: Day 14

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

    absolute change of concentration of IL-6

    Measured: Day 14

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

    percentage of change of concentration of IL-8

    Measured: Day 4

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

    absolute change of concentration of IL-8

    Measured: Day 4

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

    percentage of change of concentration of IL-8

    Measured: Day 7

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

    absolute change of concentration of IL-8

    Measured: Day 7

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

    percentage of change of concentration of IL-8

    Measured: Day 14

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

    absolute change of concentration of IL-8

    Measured: Day 14

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

    absolute change of concentration of IL-10

    Measured: Day 4

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

    percentage of change of concentration of IL-10

    Measured: Day 4

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

    absolute change of concentration of IL-10

    Measured: Day 7

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

    percentage of change of concentration of IL-10

    Measured: Day 7

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

    absolute change of concentration of IL-10

    Measured: Day 14

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

    percentage of change of concentration of IL-10

    Measured: Day 14

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

    percentage of change of concentration of INFy

    Measured: Day 4

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

    absolute change of concentration of INFy

    Measured: Day 4

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

    percentage of change of concentration of INFy

    Measured: Day 7

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

    absolute change of concentration of INFy

    Measured: Day 7

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

    percentage of change of concentration of INFy

    Measured: Day 14

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

    absolute change of concentration of INFy

    Measured: Day 14

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

    absolute change of concentration of CRP

    Measured: Day 4

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

    percentage of change of concentration of CRP

    Measured: Day 4

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

    absolute change of concentration of CRP

    Measured: Day 7

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

    percentage of change of concentration of CRP

    Measured: Day 7

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

    absolute change of concentration of CRP

    Measured: Day 14

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

    percentage of change of concentration of CRP

    Measured: Day 14

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

    percentage of change of concentration of IL-1β

    Measured: Day 4

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

    absolute change of concentration of IL-1β

    Measured: Day 4

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

    percentage of change of concentration of IL-1β

    Measured: Day 7

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

    absolute change of concentration of IL-1β

    Measured: Day 7

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

    percentage of change of concentration of IL-1β

    Measured: Day 14

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

    absolute change of concentration of IL-1β

    Measured: Day 14

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

    absolute change of concentration of INFα

    Measured: Day 4

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

    percentage of change of concentration of INFα

    Measured: Day 4

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

    absolute change of concentration of INFα

    Measured: Day 7

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

    percentage of change of concentration of INFα

    Measured: Day 7

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

    percentage of change of concentration of INFα

    Measured: Day 14

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

    absolute change of concentration of INFα

    Measured: Day 14

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

    absolute change of concentration of TNFα,

    Measured: Day 4

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

    percentage of change of concentration of TNFα,

    Measured: Day 4

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

    absolute change of concentration of TNFα,

    Measured: Day 7

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

    percentage of concentration of TNFα,

    Measured: Day 7

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

    absolute change of concentration of TNFα,

    Measured: Day 14

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

    percentage of change of concentration of TNFα,

    Measured: Day 14

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

    percentage change of neutrophils

    Measured: Day 4

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

    absolute change of neutrophils number

    Measured: Day 4

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

    percentage change of neutrophils

    Measured: Day 7

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

    absolute change of neutrophils number

    Measured: Day 7

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

    percentage change of neutrophils

    Measured: Day 14

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

    absolute change of neutrophils number

    Measured: Day 14

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

    absolute change of lymphocytes number

    Measured: Day 4

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

    percentage change of lymphocytes

    Measured: Day 4

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

    absolute change of lymphocytes number

    Measured: Day 7

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

    percentage change of lymphocytes

    Measured: Day 7

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

    absolute change of lymphocytes number

    Measured: Day 14

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

    percentage change of lymphocytes

    Measured: Day 14

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

    percentage change of monocytes

    Measured: Day 4

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

    absolute change of monocytes number

    Measured: Day 4

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

    percentage change of monocytes

    Measured: Day 7

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

    absolute change of monocytes number

    Measured: Day 7

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

    percentage of change of monocytes

    Measured: Day 14

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

    absolute change of monocytes number

    Measured: Day 14

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

    absolute change of eosinophils number

    Measured: Day 4

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

    percentage of change of eosinophils

    Measured: Day 4

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

    percentage of change of eosinophils

    Measured: Day 7

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

    absolute change of eosinophils number

    Measured: Day 7

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

    percentage of change of eosinophils

    Measured: Day 14

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

    absolute change of eosinophils number

    Measured: Day 14

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

    percentage of change of basophils number

    Measured: Day 4

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

    absolute change of basophils number

    Measured: Day 4

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

    absolute change of basophils number

    Measured: Day 7

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

    percentage of change of basophils

    Measured: Day 7

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

    absolute change of basophils number

    Measured: Day 14

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

    percentage of change of basophils

    Measured: Day 14

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

    percentage of change of platelets

    Measured: Day 4

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

    absolute change of platelet number

    Measured: Day 4

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

    percentage of change of platelets

    Measured: Day 7

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

    absolute change of platelet number

    Measured: Day 7

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

    percentage of change of platelets

    Measured: Day 14

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

    absolute change of platelet number

    Measured: Day 14

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

    percentage of change of lactate dehydrogenase (LDH)

    Measured: Day 4

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

    absolute change of lactate dehydrogenase (LDH)

    Measured: Day 4

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

    absolute change of LDH

    Measured: Day 7

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

    percentage of change of LDH

    Measured: Day 7

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

    absolute change of LDH

    Measured: Day 14

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

    percentage of change of LDH

    Measured: Day 14

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

    percentage of change of ferritin

    Measured: Day 4

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

    absolute change of ferritin

    Measured: Day 4

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

    percentage of change of ferritin

    Measured: Day 7

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

    absolute change of ferritin

    Measured: Day 7

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

    percentage of change of ferritin

    Measured: Day 14

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

    absolute change of ferritin

    Measured: Day 14

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

    absolute change of haemoglobin

    Measured: Day 4

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

    percentage of change of haemoglobin

    Measured: Day 4

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

    absolute change of haemoglobin

    Measured: Day 7

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

    percentage of change of haemoglobin

    Measured: Day 7

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

    absolute change of haemoglobin

    Measured: Day 14

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

    percentage of change of haemoglobin

    Measured: Day 14

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

    absolute change of alanine aminotransferase (ALT)

    Measured: Day 4

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

    percentage of change of alanine aminotransferase (ALT)

    Measured: Day 4

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

    absolute change of alanine aminotransferase (ALT)

    Measured: Day 7

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

    percentage of change of alanine aminotransferase (ALT)

    Measured: Day 7

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

    percentage of change of alanine aminotransferase (ALT)

    Measured: Day 14

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

    absolute change of alanine aminotransferase (ALT)

    Measured: Day 14

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

    absolute change of Aspartate aminotransferase (AST)

    Measured: Day 4

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

    absolute change of Aspartate aminotransferase (AST)

    Measured: Day 7

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

    percentage of change of Aspartate aminotransferase (AST)

    Measured: Day 7

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

    absolute change of Aspartate aminotransferase (AST)

    Measured: Day 14

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

    percentage of change of Aspartate aminotransferase (AST)

    Measured: Day 14

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

    percentage of change of activated partial thromboplastin time

    Measured: Day 4

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

    absolute change of activated partial thromboplastin time

    Measured: Day 4

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

    absolute change of activated partial thromboplastin time

    Measured: Day 7

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

    percentage of change of activated partial thromboplastin time

    Measured: Day 7

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

    percentage of change of activated partial thromboplastin time

    Measured: Day 14

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

    absolute change of activated partial thromboplastin time

    Measured: Day 14

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

    absolute change of prothrombin Z

    Measured: Day 4

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

    percentage of change of prothrombin Z

    Measured: Day 4

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

    absolute change of prothrombin Z

    Measured: Day 7

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

    percentage of change of prothrombin Z

    Measured: Day 7

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

    absolute change of prothrombin Z

    Measured: Day 14

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

    percentage of change of prothrombin Z

    Measured: Day 14

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

    percentage of change of fibrinogen

    Measured: Day 4

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

    absolute change of fibrinogen

    Measured: Day 4

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

    percentage of change of fibrinogen

    Measured: Day 7

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

    absolute change of fibrinogen

    Measured: Day 7

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

    percentage of change of fibrinogen

    Measured: Day 14

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

    absolute change of fibrinogen

    Measured: Day 14

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

    absolute change of d-dimeric

    Measured: Day 4

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

    percentage of change of d-dimeric

    Measured: Day 4

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

    absolute change of d-dimeric

    Measured: Day 7

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

    percentage of change of d-dimeric

    Measured: Day 7

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

    absolute change of d-dimeric

    Measured: Day 14

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

    percentage of change of d-dimeric

    Measured: Day 14

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

    percentage of change of fibrin-degranulation products

    Measured: Day 4

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

    absolute change of fibrin-degranulation products

    Measured: Day 4

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

    percentage of change of fibrin-degranulation products

    Measured: Day 7

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

    absolute change of fibrin-degranulation products

    Measured: Day 7

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

    percentage of change of fibrin-degranulation products

    Measured: Day 14

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

    absolute change of fibrin-degranulation products

    Measured: Day 14

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

    absolute change of anti-thrombin III activity

    Measured: Day 4

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

    percentage of change of anti-thrombin III activity

    Measured: Day 4

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

    absolute change of anti-thrombin III activity

    Measured: Day 7

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

    percentage of change of anti-thrombin III activity

    Measured: Day 7

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

    absolute change of anti-thrombin III activity

    Measured: Day 14

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

    percentage of change of anti-thrombin III activity

    Measured: Day 14

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

    percentage of change of Immunglobulin M (IgM)

    Measured: Day 4

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

    absolute change of Immunglobulin M (IgM)

    Measured: Day 4

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

    percentage of change of Immunglobulin M (IgM)

    Measured: Day 7

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

    absolute change of Immunglobulin M (IgM)

    Measured: Day 7

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

    percentage of change of Immunglobulin M (IgM)

    Measured: Day 14

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

    absolute change of Immunglobulin M (IgM)

    Measured: Day 14

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

    absolute change of Immunglobulin G (IgG)

    Measured: Day 4

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

    percentage of change of Immunglobulin G (IgG)

    Measured: Day 4

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

    absolute change of Immunglobulin G (IgG)

    Measured: Day 7

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

    percentage of change of Immunglobulin G (IgG)

    Measured: Day 7

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

    absolute change of Immunglobulin G (IgG)

    Measured: Day 14

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

    percentage of change of Immunglobulin G (IgG)

    Measured: Day 14

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

    percentage of change of Creatinin

    Measured: Day 4

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

    absolute change of Creatinin

    Measured: Day 4

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

    percentage of change of Creatinin

    Measured: Day 7

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

    absolute change of Creatinin

    Measured: Day 7

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

    percentage of change of Creatinin

    Measured: Day 14

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

    absolute change of Creatinin

    Measured: Day 14

  179. Neutrophil to lymphocyte ratio

    Neutrophil to lymphocyte number ratio

    Measured: Day 4

  180. Neutrophil to lymphocyte ratio

    Neutrophil to lymphocyte number ratio

    Measured: Day 7

  181. Neutrophil to lymphocyte ratio

    Neutrophil to lymphocyte number ratio

    Measured: Day 14

  182. IL-6/IL-10 ratio

    IL-6/IL-10 concentration ratio

    Measured: Day 4

  183. IL-6/IL-10 ratio

    IL-6/IL-10 concentration ratio

    Measured: Day 7

  184. IL-6/IL-10 ratio

    IL-6/IL-10 concentration ratio

    Measured: Day 14

  185. IL-6/INFy ratio

    IL-6/INFy concentration ratio

    Measured: Day 14

  186. IL-6/INFy ratio

    IL-6/INFy concentration ratio

    Measured: Day 7

  187. IL-6/INFy ratio

    IL-6/INFy concentration ratio

    Measured: Day 4

  188. 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)

    Measured: Day 4

  189. 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)

    Measured: Day 7

  190. 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)

    Measured: Day 14

  191. 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)

    Measured: Day 28

  192. 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)

    Measured: Day 4

  193. 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)

    Measured: Day 7

  194. 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)

    Measured: Day 14

  195. 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)

    Measured: Day 28

  196. 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)

    Measured: Day 4

  197. 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)

    Measured: Day 7

  198. 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)

    Measured: Day 14

  199. 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)

    Measured: Day 28

  200. Assessment of defervescence

    Time to defervescence in days

    Measured: Day 28

  201. Assessment of defervescence - number of patients

    Number of patients who achieved defervescence

    Measured: Day 28

  202. Assessment of defervescence - portion of patients

    Proportion of patients who achieved defervescence

    Measured: Day 28

  203. Assessment of defervescence

    Absolute temperature values and change to BL

    Measured: Day 4

  204. Assessment of defervescence

    Absolute temperature values and change to BL

    Measured: Day 7

  205. Assessment of defervescence

    Absolute temperature values and change to BL

    Measured: Day 14

  206. Assessment of defervescence

    Absolute temperature values and change to BL

    Measured: Day 28

  207. Assessment of improvement or absence of coughing

    Time to cough reported as mild oder non existent in days

    Measured: Day 28

  208. Assessment of improvement or absence of coughing

    Time to non-existent coughing for all patients in days

    Measured: Day 28

  209. 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

    Measured: Day 28

  210. 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

    Measured: Day 28

  211. Assessment of improvement or absence of coughing

    proportion of patients who achieved cough reported as none existent

    Measured: Day 28

  212. 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

    Measured: Day 28

  213. 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

    Measured: Day 28

  214. Proportion of patients who return to usual health

    proportion of patients who return to usual health

    Measured: Day 28

  215. Number of patients who return to usual health

    Number of patients who return to usual health

    Measured: Day 28

  216. proportion of patients who return to usual activity

    proportion of patients who return to usual activity

    Measured: Day 28

  217. Requirement of hospitalisation or oxygen supplementation

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

    Measured: Day 28

  218. Requirement of hospitalisation or oxygen supplementation

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

    Measured: Day 28

  219. 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

    Measured: Day 4

  220. 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

    Measured: Day 4

  221. 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

    Measured: Day 7

  222. 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

    Measured: Day 7

  223. 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

    Measured: Day 14

  224. 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

    Measured: Day 14

  225. 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

    Measured: Day 28

  226. 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

    Measured: Day 28

  227. Disease progression/improvement

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

    Measured: Day 4

  228. Disease progression/improvement

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

    Measured: Day 4

  229. Disease progression/improvement

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

    Measured: Day 7

  230. Disease progression/improvement

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

    Measured: Day 7

  231. Disease progression/improvement

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

    Measured: Day 14

  232. Disease progression/improvement

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

    Measured: Day 14

  233. Disease progression/improvement

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

    Measured: Day 28

  234. Disease progression/improvement

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

    Measured: Day 28

  235. Disease progression/improvement

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

    Measured: Day 4

  236. Disease progression/improvement

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

    Measured: Day 7

  237. Disease progression/improvement

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

    Measured: Day 14

  238. Disease progression/improvement

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

    Measured: Day 28

  239. Disease progression/improvement

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

    Measured: Day 4

  240. Disease progression/improvement

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

    Measured: Day 4

  241. Disease progression/improvement

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

    Measured: Day 7

  242. Disease progression/improvement

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

    Measured: Day 7

  243. Disease progression/improvement

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

    Measured: Day 14

  244. Disease progression/improvement

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

    Measured: Day 14

  245. Disease progression/improvement

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

    Measured: Day 28

  246. Disease progression/improvement

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

    Measured: Day 28

  247. Assessment of oxygen saturation

    Oxygen saturation measured by finger clip and change to BL

    Measured: Day 4

  248. Assessment of oxygen saturation

    Oxygen saturation measured by finger clip and change to BL

    Measured: Day 7

  249. Assessment of oxygen saturation

    Oxygen saturation measured by finger clip and change to BL

    Measured: Day 14

  250. Assessment of oxygen saturation

    Oxygen saturation measured by finger clip and change to BL

    Measured: Day 28

  251. Assessment of intake of concomitant medication

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

    Measured: Day 14

  252. Assessment of intake of concomitant medication

    Average days of additional intake of concomitant medication paracetamol

    Measured: Day 4

  253. Assessment of intake of concomitant medication

    Average days of additional intake of concomitant medication paracetamol

    Measured: Day 7

  254. Assessment of intake of concomitant medication

    Average days of additional intake of concomitant medication paracetamol

    Measured: Day 14

  255. Assessment of intake of concomitant medication

    Average days of additional intake of concomitant medication paracetamol

    Measured: Day 28

  256. Assessment of intake of concomitant medication

    Number of patients with a reduction in concomitant medication intake

    Measured: Day 14

  257. Assessment of intake of concomitant medication

    proportion of patients with a reduction in concomitant medication intake

    Measured: Day 14

  258. Number of patients with hyposmia or anosmia

    Number of patients with hyposmia or anosmia

    Measured: Day 4

  259. proportion of patients with hyposmia or anosmia

    proportion of patients with hyposmia or anosmia

    Measured: Day 4

  260. Number of patients with hyposmia or anosmia

    Number of patients with hyposmia or anosmia

    Measured: Day 7

  261. proportion of patients with hyposmia or anosmia

    proportion of patients with hyposmia or anosmia

    Measured: Day 7

  262. Number of patients with hyposmia or anosmia

    Number of patients with hyposmia or anosmia

    Measured: Day 14

  263. proportion of patients with hyposmia or anosmia

    proportion of patients with hyposmia or anosmia

    Measured: Day 14

  264. Number of patients with hyposmia or anosmia

    Number of patients with hyposmia or anosmia

    Measured: Day 28

  265. proportion of patients with hyposmia or anosmia

    proportion of patients with hyposmia or anosmia

    Measured: Day 28

  266. Number of patients with fever

    Number of patients with fever

    Measured: Day 4

  267. proportion of patients with fever

    proportion of patients with fever

    Measured: Day 4

  268. Number of patients with fever

    Number of patients with fever

    Measured: Day 7

  269. proportion of patients with fever

    proportion of patients with fever

    Measured: Day 7

  270. Number of patients with fever

    Number of patients with fever

    Measured: Day 14

  271. proportion of patients with fever

    proportion of patients with fever

    Measured: Day 14

  272. Number of patients with fever

    Number of patients with fever

    Measured: Day 28

  273. proportion of patients with fever

    proportion of patients with fever

    Measured: Day 28

  274. Number of patients with COVID-19 vaccination

    Number of patients with COVID-19 vaccination

    Measured: Day 4

  275. proportions of patients with COVID-19 vaccination

    proportions of patients with COVID-19 vaccination

    Measured: Day 4

  276. Number of patients with COVID-19 vaccination

    Number of patients with COVID-19 vaccination

    Measured: Day 7

  277. proportions of patients with COVID-19 vaccination

    proportions of patients with COVID-19 vaccination

    Measured: Day 7

  278. Number of patients with COVID-19 vaccination

    Number of patients with COVID-19 vaccination

    Measured: Day 14

  279. proportions of patients with COVID-19 vaccination

    proportions of patients with COVID-19 vaccination

    Measured: Day 14

  280. Number of patients with COVID-19 vaccination

    Number of patients with COVID-19 vaccination

    Measured: Day 28

  281. proportions of patients with COVID-19 vaccination

    proportions of patients with COVID-19 vaccination

    Measured: Day 28

  282. Number of recovered COVID-19 patients

    Number of recovered COVID-19 patients

    Measured: Day 4

  283. proportion of recovered COVID-19 patients

    proportion of recovered COVID-19 patients

    Measured: Day 4

  284. Number of recovered COVID-19 patients

    Number of recovered COVID-19 patients

    Measured: Day 7

  285. proportion of recovered COVID-19 patients

    proportion of recovered COVID-19 patients

    Measured: Day 7

  286. Number of recovered COVID-19 patients

    Number of recovered COVID-19 patients

    Measured: Day 14

  287. proportion of recovered COVID-19 patients

    proportion of recovered COVID-19 patients

    Measured: Day 14

  288. Number of recovered COVID-19 patients

    Number of recovered COVID-19 patients

    Measured: Day 28

  289. proportion of recovered COVID-19 patients

    proportion of recovered COVID-19 patients

    Measured: Day 28

  290. 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)

    Measured: Day 4

  291. Assessment of SARS-CoV-2 negativity

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

    Measured: Day 7

  292. Assessment of SARS-CoV-2 negativity

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

    Measured: Day 14

  293. Assessment of SARS-CoV-2 negativity

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

    Measured: Day 28

  294. Assessment of compliance

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

    Measured: Day 4

  295. Assessment of compliance

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

    Measured: Day 7

  296. Assessment of compliance

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

    Measured: Day 14

  297. Number of adverse events (AE)

    Number of adverse events (AE)

    Measured: through study completion, average 28 days

  298. Number of serious adverse events (SAE)

    Number of serious adverse events (SAE)

    Measured: through study completion, average 28 days

  299. Type and severity of adverse events

    Type and severity of adverse events

    Measured: through study completion, average 28 days

  300. Type and severity of serious adverse events

    Type and severity of serious adverse events

    Measured: through study completion, average 28 days

  301. Seriousness and relatedness of AEs

    Seriousness and relatedness of AEs

    Measured: through study completion, average 28 days

  302. Seriousness and relatedness of SAEs

    Seriousness and relatedness of SAEs

    Measured: through study completion, average 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start14 Jan 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparison of Verum (Bronchipret) versus no verum i.d. standard of care
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05276375
Sponsor's protocol ID
TMP-2005-2020-36
Acronym
BroVID
Status last verified
Aug 2024
First submitted
2 Mar 2022
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bronchipret in people with COVID-19, run by Dr. Frank Behrens at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average concentration of immunologic markers (time frame: Comparison Baseline to day 7). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05276375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

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