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

G. Pohl-Boskamp GmbH & Co. KG0 sites150 target enrollmentNovember 13, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 13, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 enrolment; samples of 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 according to investigators assessment.
•4\.Signed informed consent and data protection declaration prior to initiation of any trial procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 100
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 50

•1\.Acute respiratory distress syndrome (ARDS) at time of inclusion2\.
•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