- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04500418
Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
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-19 patients, will also be assessed. Furthermore, the clinical trial aims to answer the question of whether patients with pre-existing conditions, who have an increased risk of severe COVID-19 progression, benefit more and particularly from CVC. CVC is an orally available dual inhibitor of the chemokine receptors CCR2 and CCR5, which is expected to reduce (hyper-) inflammation in COVID-19.
The main goal of the study is to determine whether CVC helps increase the number of patients who are symptom-free and not hospitalized after 14 days compared to a placebo. Approximately 66.7% of the patients enrolled in the study will receive CVC and 33.3% will get an optically identical pill (placebo).
Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 8, 15, 22, and 29 and 85. All subjects will undergo a series of clinical, safety, and laboratory assessments. Blood samples and oropharyngeal (OP) swabs will be obtained on Day 1; 3, 5 (while hospitalized); and Day 8, 15 and 29 (if able to return to clinic or still hospitalized). The presence of anti-SARS-CoV-2 antibodies will be determined on Days 29 and 85.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cenicriviroc (CVC)
Approximately 122 patients.
Day 1: CVC 450 mg (300 mg AM; 150 mg PM; if patients receive their first dose on Day 1 past 2 PM, then their evening dose will be 300 mg and their next dose will be the following AM.) Days 2-28: CVC BID 150 mg (AM/PM).
Every dose should be taken with food (within 30 min).
|
Treatment with Cenicriviroc tablets of 150mg.
(450g/300g on day 1 and 300mg/d on days 2-28).
Other Names:
|
Placebo Comparator: Placebo
Approximately 61 patients.
A matching placebo will be given to the patients in the Placebo group at an equal volume and at the same schedule.
|
Optically identical pills without CVC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject´s Responder status (score on the 7-point ordinal scale on Day 15)
Time Frame: 14 days after enrollment (Day 15)
|
The Primary Endpoint will be the subject's responder status defined by achieving a score of "1" or "2" (discharged from hospital e.g.) on Day 15 on the following 7-point scale:
|
14 days after enrollment (Day 15)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of change in clinical condition based on the 7-point ordinal scale
Time Frame: day of enrollment and 15 days after enrollment
|
7-point ordinal scale to be assessed on Day 15 (and Day 1 for baseline comparison), analyses of
|
day of enrollment and 15 days after enrollment
|
Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status
Time Frame: day of enrollment, 8 days, 22 days and 29 days after enrollment
|
7-point ordinal scale assessed on: Days 8, 22, 29 (and Day 1 for baseline comparison), analyses of:
|
day of enrollment, 8 days, 22 days and 29 days after enrollment
|
Hospital resource utilization comparison
Time Frame: 29 days after enrollment, 85 days after enrollment
|
Analysis of:
|
29 days after enrollment, 85 days after enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frank Tacke, Prof. Dr.med., Charite University, Berlin, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- CCR5 Receptor Antagonists
- Cenicriviroc
Other Study ID Numbers
- CVC for COVID-19
- 2020-001493-29 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on Cenicriviroc (CVC)
-
Novartis PharmaceuticalsAllerganCompletedNon-alcoholic Steatohepatitis (NASH)United States, Belgium, Spain, Canada, Argentina, Israel, Germany, France, Italy, Turkey, Singapore, Russian Federation, United Kingdom, Czechia, Egypt, India, Latvia
-
National Institute of Allergy and Infectious Diseases...AllerganWithdrawn
-
Tobira Therapeutics, Inc.CompletedPrimary Sclerosing CholangitisUnited States, Canada
-
Tobira Therapeutics, Inc.CompletedLiver InsufficiencyUnited States
-
Bactiguard ABDanderyd HospitalTerminatedCatheter-Related Infections | Catheter Bacteraemia | Vascular Access Complication | Catheter Complications | Catheter Site Discomfort | Catheter Blockage | Catheter ThrombosisSweden
-
AllerganCompletedHepatic ImpairmentUnited States
-
Tobira Therapeutics, Inc.TerminatedNonalcoholic SteatohepatitisUnited States, Spain, Australia, Belgium, Israel, Canada, Puerto Rico, Italy, Germany, France, New Zealand, Taiwan, Poland, United Kingdom, Brazil, Austria, Singapore, Portugal, Chile, Greece, Hong Kong, Hungary, Latvia, Mexico, Norway, R... and more
-
Tobira Therapeutics, Inc.TerminatedLiver Cirrhosis | Non-alcoholic Fatty Liver Disease | Nonalcoholic SteatohepatitisUnited States, Australia, France, Germany, Spain, Poland, United Kingdom, Italy, Puerto Rico, Belgium, Hong Kong
-
Catholic University of the Sacred HeartISS, Dip.Tecnologie e Salute, Prof. Gianfranco DonelliCompletedCentral Venous Catheter Related InfectionsItaly
-
National Institute of Allergy and Infectious Diseases...AbbVieActive, not recruitingHIV-1-infectionUnited States