Clinical trial NCT04500418: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Keywords: COVID-19
Cenicriviroc
CVC
SARS-CoV-2
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2020-08-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Subject´s Responder status (score on the 7-point ordinal scale on Day 15)
timeFrame: 14 days after enrollment (Day 15)
Secondary outcomes:
measure: Evaluation of change in clinical condition based on the 7-point ordinal scale
timeFrame: day of enrollment and 15 days after enrollment
measure: Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status
timeFrame: day of enrollment, 8 days, 22 days and 29 days after enrollment
measure: Hospital resource utilization comparison
timeFrame: 29 days after enrollment, 85 days after enrollment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM)
Study officials:
affiliation: Charité University, Berlin, Germany
name: Frank Tacke, Prof. Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: