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

G. Pohl-Boskamp GmbH & Co. KG0 sites47 target enrollmentFebruary 25, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 25, 2021

End Date

July 19, 2021

Last Updated

last year

Study Type

Interventional

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 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

•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