Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients

Inclusion Criteria:

• Subject provides written informed consent prior to initiation of any study procedures.Understands and agrees to comply with planned study procedures.
• Male or non-pregnant female adult ≥18 years of age at time of enrolment.
• Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR and fulfils thecase criteria of COVID-19 (One or more of the following must be met in lieu of apositive PCR test: fever [defined as a temperature ≥ 100.0°F / 37.8°C documentedwithin 24 hr. of randomization] , absolute and relative lymphopenia and leukopenia,new typical infiltrates in x-ray of the chest or chest CT scan [only if obtained forclinical reasons; not required by study], no improvement on antibiotics).
• Scoring a "3" or "4" (or "5", at the Investigator's discretion) on the 7-Point OrdinalScale (see Outcome Measures) at enrolment. Note, if scoring a "2" at screening,inclusion will be met if the patient is in the process of being hospitalized oradmitted to an inpatient setting. Such a patient would be assigned a "3" at enrolmentfor Baseline assessment purposes.
• No participation in other clinical trials according to the German Medicines Act (AMG) (3 months before) at the time of this trial.

Exclusion Criteria:

• ALT/AST > 5 times the upper limit of normal.
• Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B orC)
• Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR < 30 ml/min)
• Advanced cardiac (eg, severe heart failure [NYHA III-IV]) or pulmonary diseases which,in the Investigator's judgment, would not make participation appropriate.
• Pregnancy or breast feeding.
• Anticipated transfer to another hospital which is not a study site within 72 hours.
• Known allergy or hypersensitivity to CVC or its components.
• Use of medications that are contraindicated with CVC and that could not be replaced orstopped during the trial period
• Administration of specified drugs which interfere with the metabolism of CVC.
• Patients immediately or imminently requiring mechanical ventilation.
• Patients unwilling to consent to saving and propagation of pseudonymised medical datafor study reasons.
• Subjects who are legally detained in an official institution.
• Subjects that are unsuitable to understand or to comply with the study requirements inthe opinion of the investigator.
• Subjects who may be dependent on the sponsor, the investigator or the trial sites.