Charité trial of Cenicriviroc (CVC) treatment for COVID-19 patients
- Conditions
- SARS-CoV-2 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001493-29-DE
- Lead Sponsor
- Charité - Universitaetsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1.Subject provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures.
2.Male or non-pregnant female adult =18 years of age at time of enrolment.
3.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR (date of sample collection maximal 10 days prior to randomization) 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).
4.Scoring a 3” or 4” (or 5”, at the Investigator’s discretion) on the cited 7-Point Ordinal Scale at enrolment.
oNote, 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
5.No participation in other clinical trials according to AMG (3 months before) at the time of this trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1.ALT/AST > 5 times the upper limit of normal.
2.Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B or C)
3.Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR < 30 ml/min)
4.Advanced cardiac (eg, severe heart failure [NYHA III-IV])
or pulmonary diseases which, in the Investigator's judgment, would not make participation appropriate.
5.Pregnancy or breast feeding.
6.Anticipated transfer to another hospital which is not a study site within 72 hours.
7.Known allergy or hypersensitivity to CVC or its components
8.Use of medications that are contraindicated with CVC and that could not be replaced or stopped during the trial period
9.Administration of specified drugs which interfere with the metabolism of CVC (see listing in protocol body for allowed or disallowed medication and CVC’s drug metabolism pathway (section 9.1.13)
10.Patients immediately or imminently requiring mechanical ventilation.
11.Patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
12.Subjects who are legally detained in an official institution
13.Subjects that are unsuitable to understand or to comply with the study requirements or in the opinion of the investigator
14.Subjects who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method