Trial document





This trial has been registered retrospectively.
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  DRKS00024585

Trial Description

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Title

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

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Trial Acronym

COVARI study

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URL of the Trial

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Brief Summary in Lay Language

Aim of the COVARI study is to evaluate, whether a herbal medicinal product, administered on top of standard of care specific for the respective study centre, induces an improvement of the clinical status of the patients.

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Brief Summary in Scientific Language

Patients are hospitalised due to COVID-19 and acute respiratory insufficiency (ARI) and admitted to a separate isolation ward. The clinical picture presents a stable patient with respiratory and/or systemic symptoms or signs at time of admission and a need for supplemental oxygen, but does initially not present any clinical features suggesting a complicated course of illness (non-ARDS), or need for immediate transfer to intermediate (IMC) or intensive care unit (ICU). The clinical trial comprises 29 days with daily trial specific assessments as long as the patient is hospitalised. If the patient was discharged from hospital before Day 29, he / she is requested to complete diary until Day 29. End of trial evaluations will be performed on Day 29 - either inpatient or outpatient, depending on what applies.
Eligible and consenting patients are randomly assigned to a 14-days (i.e. 336 hours) treatment (including hospitalised and discharged patients) with investigational medicinal product (IMP), either PB432 capsules or matched placebo. Both interventions are applied as add-on to centre specific COVID-19 related care.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00024585
  •   2021/02/25
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  •   no
  •   Approved
  •   EK408/20, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  •   2020-003779-17 
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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Verum, PB432
    Capsule
    One capsule contains 300 mg distillate of a mixture of four rectified essential oils
    Oral administration
    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
  •   Matching placebo capsules
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   II-III
  •   Yes
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Primary Outcome

• The daily scores of Ordinal Status Score (OSS) evaluating the clinical status of the patients, 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.

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Secondary Outcome

• The 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2021/01/19
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Male / female / diverse adult ≥18 years of age at time of enrolment
2. Laboratory-confirmed SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test in any defined specimen prior to trial inclusion; samples of the first positive test collected within 8 (for symptomatic patients at the time of test) respectively 14 (for asymptomatic patients at the time of test) calendar days prior to randomisation are accepted.
3. 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.
4. Signed informed consent and data protection declaration prior to initiation of any trial procedures

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Exclusion Criteria

1. Acute respiratory distress syndrome (ARDS) at time of inclusion
2. Relevant laboratory abnormality (serum liver enzymes (ASAT, ALAT, GGT) >3x upper range of normality)
3. Known hypersensitivity to trial medication or excipients
4. Presence of inflammatory gastrointestinal disease (e.g. Crohn´s Disease, or colitis ulcerosa, diverticulitis or non-infectious acute gastritis) at time of inclusion
5. Presence of acute or recurrent inflammatory disease of the gall bladder and / or biliary ducts at time of inclusion
6. Severe hepatic disease (e.g. liver cirrhosis Child Pugh B or C, ongoing viral hepatitis) at time of inclusion
7. Hereditary fructose intolerance
8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min)
9. Only for female patients of childbearing potential: Pregnancy, positive urine pregnancy test on Day 1, breast feeding or no use of effective contraception
10. 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
11. Use of systemic immunosuppressants (except corticosteroids) within 4 weeks before inclusion into the clinical trial
Others
12. Patient in another clinical trial with an investigational medicinal product within 30 days before inclusion into the present clinical trial
13. Known to be or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
14. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
15. Patient in custody by juridical or official order evidence of an uncooperative attitude
16. Patient, who is a member of the staff of the study centre, staff of the sponsor or CRO, the investigator him- / herself or close relatives of the investigator

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Addresses

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    • G. Pohl-Boskamp GmbH & Co. KG
    • Kieler Straße 11
    • 25551  Hohenlockstedt
    • Germany
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    • G. Pohl-Boskamp GmbH & Co. KG
    • Mr.  Dr. med.  Thomas  Wittig 
    • Kieler Straße 11
    • 25551  Hohenlockstedt
    • Germany
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    • Mr.  Dr. med.  Thomas  Wittig 
    • Kieler Straße 11
    • 25551  Hohenlockstedt
    • Germany
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Sources of Monetary or Material Support

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    • G. Pohl-Boskamp GmbH & Co. KG
    • Kieler Straße 11
    • 25551  Hohenlockstedt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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