Back to resultsCharité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cenicriviroc (CVC)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Cenicriviroc, CVC, SARS-CoV-2
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.
Sites / Locations
- Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cenicriviroc (CVC)
Placebo
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Subject´s Responder status (score on the 7-point ordinal scale on 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:
Not hospitalized, no limitations on activities;
Not hospitalized, limitation on activities;
Hospitalized, not requiring supplemental oxygen;
Hospitalized, requiring supplemental oxygen;
Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation);
Death.
Secondary Outcome Measures
Evaluation of change in clinical condition based on the 7-point ordinal scale
7-point ordinal scale to be assessed on Day 15 (and Day 1 for baseline comparison), analyses of
ordinal change of 2 or more, compared with baseline
ordinal change of 1 or more, compared with baseline
Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status
7-point ordinal scale assessed on: Days 8, 22, 29 (and Day 1 for baseline comparison), analyses of:
Responder status (achieving a score of a "1" or a "2")
ordinal change of 2 or more, compared with baseline
ordinal change of 1 or more, compared with baseline
Hospital resource utilization comparison
Analysis of:
Length of time spent in the ICU (days)
Length of time spent in the hospital (days)
Days alive and out of hospital through Day 29
Days free of endotracheal tube-based ventilation through Day 29
Full Information
NCT ID
NCT04500418
First Posted
August 4, 2020
Last Updated
March 14, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT04500418
Brief Title
Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
Official Title
Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Despite multiple efforts, no further patient could be enrolled since 03/05/2021. A continuation of the study is therefore no longer justified
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
July 27, 2021 (Actual)
Study Completion Date
July 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, Cenicriviroc, CVC, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A monocentric, randomized, double-blind, placebo-controlled trial.
Randomization will be stratified by:
Presence of baseline score of "3" on 7-point ordinal scale versus presence of baseline score of "4" or "5" on seven-point ordinal scale
Presence of one or more of the following comorbidities: Diabetes mellitus, Obesity (BMI >30kg/m2), COPD or Asthma, Heart failure (NYHA Class I or II)
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cenicriviroc (CVC)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cenicriviroc (CVC)
Other Intervention Name(s)
Cenicriviroc Mesylate
Intervention Description
Treatment with Cenicriviroc tablets of 150mg. (450g/300g on day 1 and 300mg/d on days 2-28).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Optically identical pills without CVC.
Primary Outcome Measure Information:
Title
Subject´s Responder status (score on the 7-point ordinal scale on Day 15)
Description
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:
Not hospitalized, no limitations on activities;
Not hospitalized, limitation on activities;
Hospitalized, not requiring supplemental oxygen;
Hospitalized, requiring supplemental oxygen;
Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation);
Death.
Time Frame
14 days after enrollment (Day 15)
Secondary Outcome Measure Information:
Title
Evaluation of change in clinical condition based on the 7-point ordinal scale
Description
7-point ordinal scale to be assessed on Day 15 (and Day 1 for baseline comparison), analyses of
ordinal change of 2 or more, compared with baseline
ordinal change of 1 or more, compared with baseline
Time Frame
day of enrollment and 15 days after enrollment
Title
Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status
Description
7-point ordinal scale assessed on: Days 8, 22, 29 (and Day 1 for baseline comparison), analyses of:
Responder status (achieving a score of a "1" or a "2")
ordinal change of 2 or more, compared with baseline
ordinal change of 1 or more, compared with baseline
Time Frame
day of enrollment, 8 days, 22 days and 29 days after enrollment
Title
Hospital resource utilization comparison
Description
Analysis of:
Length of time spent in the ICU (days)
Length of time spent in the hospital (days)
Days alive and out of hospital through Day 29
Days free of endotracheal tube-based ventilation through Day 29
Time Frame
29 days after enrollment, 85 days after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Tacke, Prof. Dr.med.
Organizational Affiliation
Charité University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided at this moment. (08/2020)
Learn more about this trial
Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
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