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Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04500418
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Prof. Dr. med. Frank Tacke, Charite University, Berlin, Germany

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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Cenicriviroc (CVC) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

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).
Drug: Cenicriviroc (CVC)
Treatment with Cenicriviroc tablets of 150mg. (450g/300g on day 1 and 300mg/d on days 2-28).
Other Name: Cenicriviroc Mesylate

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.
Drug: Placebo
Optically identical pills without CVC.




Primary Outcome Measures :
  1. 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:

    1. Not hospitalized, no limitations on activities;
    2. Not hospitalized, limitation on activities;
    3. Hospitalized, not requiring supplemental oxygen;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
    6. Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation);
    7. Death.


Secondary Outcome Measures :
  1. 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

    • ordinal change of 2 or more, compared with baseline
    • ordinal change of 1 or more, compared with baseline

  2. 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:

    • 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

  3. Hospital resource utilization comparison [ Time Frame: 29 days after enrollment, 85 days after enrollment ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500418


Contacts
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Contact: Frank Tacke, Prof. Dr. med. +49 30 450 553 022 frank.tacke@charite.de
Contact: Christoph Jochum, PD Dr. med. +49 30 450 514 102 christoph.jochum@charite.de

Locations
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Germany
Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM) Recruiting
Berlin, Germany, 10117
Contact: Frank Tacke, Prof. Dr. med.    +4930450553022    frank.tacke@charite.de   
Contact: Christoph Jochum, PD Dr. med.    +4930450514102    christoph.jochum@charite.de   
Principal Investigator: Frank Tacke, Prof. Dr. med.         
Sub-Investigator: Christoph Jochum, PD Dr. med.         
Sub-Investigator: Münevver Demir, PD Dr. med.         
Sub-Investigator: Florian Kurth, PD Dr. med.         
Sub-Investigator: Christoph Ruwwe-Glösenkamp, Dr. med.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Allergan
Investigators
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Principal Investigator: Frank Tacke, Prof. Dr.med. Charité University, Berlin, Germany
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Responsible Party: Prof. Dr. med. Frank Tacke, Prof. Dr. med., PhD, MHBA, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04500418    
Other Study ID Numbers: CVC for COVID-19
2020-001493-29 ( EudraCT Number )
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided at this moment. (08/2020)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. med. Frank Tacke, Charite University, Berlin, Germany:
COVID-19
Cenicriviroc
CVC
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cenicriviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents