Direkt zum Inhalt

Als eigene Infrastruktur am Deutschen Zentrum für Infektionsforschung (DZIF) erfassen die Klinischen Studienzentren die Studienaktivitäten des DZIF im „Healex Site Management System (SMS)“. Die Studien werden nach Indikationen sortiert dargestellt und laufend aktualisiert.

Das Studienregister wurde aktuell um die Kategorie „COVID-19“ erweitert. Hier werden erstmals nicht ausschließlich DZIF-Studienaktivitäten dargestellt. Um in der aktuellen Pandemielage einen umfassenden Überblick zu den in Deutschland geplanten und bereits aktiven COVID-19 Studien bereitstellen zu können, kooperieren die Klinischen Studienzentren mit Forschern aus unterschiedlichen Deutschen Zentren der Gesundheitsforschung und weiteren Netzwerken.

Für Forschende: Falls Sie Ihre Studie in unserem Portal vermissen sollten, wenden Sie sich gerne an das Projektmanagement der Klinischen Studienzentren (angela.steinbach@uk-koeln.de oder vassiliki.dimitriou@uk-koeln.de).

COVARI

PrüfplancodeISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
P2003GF2020-003779-17DRKS00024585

A clinical trial to assess the efficacy and safety of PB432 in COVID-19 positive inpatients with acute respiratory insufficiency (ARI)

Status: Aktiv

Studienziel / Fragestellung

Primäres Prüfziel

To assess efficacy and safety of PB432 within the treatment of COVID-19 patients on top of best supportive care

  • Daily scores of Ordinal Status Score (OSS; assessment of clinical status) will be summed up from Day 2 to Day 15, defined as SOSS-14 (sum of OSS) and Day 1 value will be used as baseline. This primary endpoint is based on the 7-point score that was mentioned above
  • The number of days from Day 1 (randomisation) until first increase (improvement) by at least two points in OSS compared to Day 1

Sekundäre Prüfziele

  • Daily Scores of OSS will be summed-up from Day 2 to Day 29, defined as SOSS-28 and will be evaluated analogously to the first primary endpoint
  • Time to patient satisfies categories 5, 6 or 7 on the above mentioned 7 category ordinal scale
  • Time to discharge (duration of hospitalisation)
  • Time to OSS score ≤2 (ICU admission / death)
  • Mortality
  • Percent of patient discharged till Day 8, 15, 22, 29
  • Proportion of patients with SARS-CoV-2 free nasopharyngeal / oropharyngeal swabs / sputum samples (virus-free) on Days 8, 15, 22, 29
  • Proportion of patients with interference of daily activities by dyspnoea at least once after discharge
  • SAEs/AEs
  • Safety laboratory data
  • Course of typical COVID-19 symptoms from Day 2 to Day 15, i.e. shortness of breath or difficulty breathing, cough, sore throat, congested or runny nose, fatigue, muscle or body aches, headache, loss of taste or smell, nausea or vomiting, diarrhoea
  • Interference in daily activities as a result of COVID-19 infection by dyspnoea documented in the diary
  • Days Alive and Out of Hospital until Day 29 (DAOH-28)
  • Course of IL-6 (ng/L) and CRP (mg/dL)

 

Diagnose

Patientenmerkmale

Einschlusskriterien

  • Male / female / diverse adult ≥18 years of age at time of enrolment
  • Laboratory-confirmed SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test in any defined specimen prior to trial inclusion
  • Inpatient admitted to an isolation ward with dyspnoea and / or tachypnoea (e.g. respiratory rate >20/minute) in stable conditions (i.e. without immediate plans for intermediate (IMC) or intensive care unit (ICU) transfer) and a need for supplemental oxygen with low-flow (i.e. up to 5 L/min) nasal cannula acc. to investigators assessment.
  • Signed informed consent and data protection declaration prior to initiation of any trial procedures

 

Ausschlusskriterien

  • Acute respiratory distress syndrome (ARDS) at time of inclusion
  • Relevant laboratory abnormality (serum liver enzymes (ASAT, ALAT, GGT) >3x upper range of normality)
  • Known hypersensitivity to trial medication or excipients
  • Active malignancy (active = running or immediately planned treatment options like e.g. surgery, chemo- or radiation therapy) or condition after carcinoma not longer than 2 years without relapse, which would make it in the opinion of the investigator unsafe or unsuitable for the patient to participate in this clinical trial
  • Use of systemic immunosuppressants (except corticosteroids) within 4 weeks before inclusion into the clinical trial
  • Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
  • Patients in custody by juridical or official order evidence of an uncooperative attitude

 

Studiendesign

  • Phase II
  • Phase III
  • Multizentrisch
  • Prospektiv
  • Randomisiert
  • Parallel
  • Doppelblind
  • Placebo-kontrolliert

Intervention

  • PB432 capsules (GeloMyrtol® forte), to be taken orally and matching placebo capsules; randomization 1:1
  • Enhancement of mucociliary clearance
  • One capsule contains 300 mg distillate of a mixture of four rectified essential oils
  • Dosing: 2 capsules four times a day (i.e. in the morning, at noon, in the evening, and at bedtime). Each capsule has to be intactly swallowed approximately 30 minutes before a meal or before bedtime
  • Eligible and consenting patients are randomly assigned to a 14-days treatment with investigational medicinal product (IMP), either PB432 capsules or matched placebo capsules. Both interventions are applied as add-on to centre specific COVID-19 related care. Active treatment will be followed by a follow-up phase of 14 days

 

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

G. Pohl-Boskamp GmbH & Co. KG

    Leiter der klinischen Prüfung

    Univ.-Prof. Dr. med. Michael Dreher

    Direkt zum Inhalt

    Als eigene Infrastruktur am Deutschen Zentrum für Infektionsforschung (DZIF) erfassen die Klinischen Studienzentren die Studienaktivitäten des DZIF im „Healex Site Management System (SMS)“. Die Studien werden nach Indikationen sortiert dargestellt und laufend aktualisiert.

    Das Studienregister wurde aktuell um die Kategorie „COVID-19“ erweitert. Hier werden erstmals nicht ausschließlich DZIF-Studienaktivitäten dargestellt. Um in der aktuellen Pandemielage einen umfassenden Überblick zu den in Deutschland geplanten und bereits aktiven COVID-19 Studien bereitstellen zu können, kooperieren die Klinischen Studienzentren mit Forschern aus unterschiedlichen Deutschen Zentren der Gesundheitsforschung und weiteren Netzwerken.

    Für Forschende: Falls Sie Ihre Studie in unserem Portal vermissen sollten, wenden Sie sich gerne an das Projektmanagement der Klinischen Studienzentren (angela.steinbach@uk-koeln.de oder vassiliki.dimitriou@uk-koeln.de).

    COVARI

    PrüfplancodeISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
    P2003GF2020-003779-17DRKS00024585

    A clinical trial to assess the efficacy and safety of PB432 in COVID-19 positive inpatients with acute respiratory insufficiency (ARI)

    Status: Aktiv

    Studienziel / Fragestellung

    Primäres Prüfziel

    To assess efficacy and safety of PB432 within the treatment of COVID-19 patients on top of best supportive care

    • Daily scores of Ordinal Status Score (OSS; assessment of clinical status) will be summed up from Day 2 to Day 15, defined as SOSS-14 (sum of OSS) and Day 1 value will be used as baseline. This primary endpoint is based on the 7-point score that was mentioned above
    • The number of days from Day 1 (randomisation) until first increase (improvement) by at least two points in OSS compared to Day 1

    Sekundäre Prüfziele

    • Daily Scores of OSS will be summed-up from Day 2 to Day 29, defined as SOSS-28 and will be evaluated analogously to the first primary endpoint
    • Time to patient satisfies categories 5, 6 or 7 on the above mentioned 7 category ordinal scale
    • Time to discharge (duration of hospitalisation)
    • Time to OSS score ≤2 (ICU admission / death)
    • Mortality
    • Percent of patient discharged till Day 8, 15, 22, 29
    • Proportion of patients with SARS-CoV-2 free nasopharyngeal / oropharyngeal swabs / sputum samples (virus-free) on Days 8, 15, 22, 29
    • Proportion of patients with interference of daily activities by dyspnoea at least once after discharge
    • SAEs/AEs
    • Safety laboratory data
    • Course of typical COVID-19 symptoms from Day 2 to Day 15, i.e. shortness of breath or difficulty breathing, cough, sore throat, congested or runny nose, fatigue, muscle or body aches, headache, loss of taste or smell, nausea or vomiting, diarrhoea
    • Interference in daily activities as a result of COVID-19 infection by dyspnoea documented in the diary
    • Days Alive and Out of Hospital until Day 29 (DAOH-28)
    • Course of IL-6 (ng/L) and CRP (mg/dL)

     

    Diagnose

    Patientenmerkmale

    Einschlusskriterien

    • Male / female / diverse adult ≥18 years of age at time of enrolment
    • Laboratory-confirmed SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test in any defined specimen prior to trial inclusion
    • Inpatient admitted to an isolation ward with dyspnoea and / or tachypnoea (e.g. respiratory rate >20/minute) in stable conditions (i.e. without immediate plans for intermediate (IMC) or intensive care unit (ICU) transfer) and a need for supplemental oxygen with low-flow (i.e. up to 5 L/min) nasal cannula acc. to investigators assessment.
    • Signed informed consent and data protection declaration prior to initiation of any trial procedures

     

    Ausschlusskriterien

    • Acute respiratory distress syndrome (ARDS) at time of inclusion
    • Relevant laboratory abnormality (serum liver enzymes (ASAT, ALAT, GGT) >3x upper range of normality)
    • Known hypersensitivity to trial medication or excipients
    • Active malignancy (active = running or immediately planned treatment options like e.g. surgery, chemo- or radiation therapy) or condition after carcinoma not longer than 2 years without relapse, which would make it in the opinion of the investigator unsafe or unsuitable for the patient to participate in this clinical trial
    • Use of systemic immunosuppressants (except corticosteroids) within 4 weeks before inclusion into the clinical trial
    • Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
    • Patients in custody by juridical or official order evidence of an uncooperative attitude

     

    Studiendesign

    • Phase II
    • Phase III
    • Multizentrisch
    • Prospektiv
    • Randomisiert
    • Parallel
    • Doppelblind
    • Placebo-kontrolliert

    Intervention

    • PB432 capsules (GeloMyrtol® forte), to be taken orally and matching placebo capsules; randomization 1:1
    • Enhancement of mucociliary clearance
    • One capsule contains 300 mg distillate of a mixture of four rectified essential oils
    • Dosing: 2 capsules four times a day (i.e. in the morning, at noon, in the evening, and at bedtime). Each capsule has to be intactly swallowed approximately 30 minutes before a meal or before bedtime
    • Eligible and consenting patients are randomly assigned to a 14-days treatment with investigational medicinal product (IMP), either PB432 capsules or matched placebo capsules. Both interventions are applied as add-on to centre specific COVID-19 related care. Active treatment will be followed by a follow-up phase of 14 days

     

    Dokumente (passwortgeschützt)

    Zuständigkeiten Gesamtstudie

    G. Pohl-Boskamp GmbH & Co. KG

      Leiter der klinischen Prüfung

      Univ.-Prof. Dr. med. Michael Dreher