Clinical trial: Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients (NCT04500418)

Eligibility criteria:
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 the
             case criteria of COVID-19 (One or more of the following must be met in lieu of a
             positive PCR test: fever [defined as a temperature ≥ 100.0°F / 37.8°C documented
             within 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 for
             clinical 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 Ordinal
             Scale (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 or
             admitted to an inpatient setting. Such a patient would be assigned a "3" at enrolment
             for 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 or
             C)

          -  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 or
             stopped 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 data
             for study reasons.

          -  Subjects who are legally detained in an official institution.

          -  Subjects that are unsuitable to understand or to comply with the study requirements in
             the opinion of the investigator.

          -  Subjects who may be dependent on the sponsor, the investigator or the trial sites.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment