CCR1 antagonist treatment in patients hospitalized with COVID-19

ABSTRACT

ConditionCOVID-19 - SARS-CoV-2 infection

InterventionGroup 1 CCR-1 inhibitor BAY86-5277, per os, 4x600mg / d (q6h) for 10d
Group 2 Placebo = Diluent, active macrogol 400 based solution, d (q6h) for 10 d


Primary outcome:ventilator-free days at day 28

CriteriaInclusion criteria Positive laboratory-confirmed SARS-CoV-2 PCR test, WHO clinical progression scale 5-6, Onset of COVID-19 symptoms < 10 days before randomization, Age = 18 years, Male or non-pregnant/non-breast-feeding female, Subject understands the clinical trial and signed the informed consent form

Exclusion criteria Patients has a chance of survival < 48 hours at time of randomization, Participation in another interventional clinical trial, Specific immunomodulatory treatment for COVID-19 according to the german S3 living guideline on therapy for patient hospitalized for COVID-19 longer than 72 hours before randomization, Other indications for systemic or inhaled glucocorticoid treatment, Immunosuppressive medication within the last 30 days before randomization, Immunosuppressive disease, Chronic inflammatory airways disease (e.g., COPD), Renal failure requiring dialysis, Chronic liver failure (Child-Pugh class C), Acute (or acute on chronic) liver failure
Chronic heart failure NYHA III/IV,
Acute right heart failure,
Clear evidence of active tuberculosis, bacterial, fungal, viral, or other infection (besides SARSCoV-2),
Current or regular treatment with Chloramphenicol,
Current or regular treatment with Nefazodone,
Current or regular treatment with Cimetidin,
Current or regular treatment with macrolide antibiotics,
Current or regular treatment with azole antimycotics,
Treatment with Phenytoin,
Person is placed in an institution based on an official or judicial order,
Person who is dependent on the Sponsor,
Principal Investigators, or the study site