DRKS00024585Active, not recruitingPhase 2
A clinical trial to assess the efficacy and safety of PB432 in COVID-19 positive inpatients with acute respiratory insufficiency (ARI)- COVARI study - - COVARI study
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 47
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
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
- •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
Investigators
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