CCR1 antagonist treatment in patients hospitalized with COVID-19
- Conditions
- COVID-19 - SARS-CoV-2 infection
- Registration Number
- DRKS00024465
- Lead Sponsor
- Charité Campus Benjamin Franklin, Medizinische Klinik für Kardiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 5
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ventilator-free days at day 28
- Secondary Outcome Measures
Name Time Method WHO clinical progression scale,<br>Severity of gas exchange impairment<br>(paO2/FiO2),<br>Duration in days of supplemental oxygen,<br>Duration in days of MV,<br>ICU-free days,<br>Duration in days of hospitalization,<br>SOFA at Day 1, 10, 28,<br>Mortality