Status:
TERMINATED
Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Allergan
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to test Cenicriviroc (CVC) as a means to reduce the severity of the lung disease COVID-19 caused by an infection with SARS-CoV-2. The safety of CVC, when administered to COVID...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04500418
Start Date
August 25 2020
End Date
July 27 2021
Last Update
March 29 2022
Active Locations (1)
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1
Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM)
Berlin, Germany, 10117