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

NCT04500418 | Terminated Phase 2 DMC

• 2 other identifiers: CVC for COVID-192020-001493-29
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID-19; Cenicriviroc; CVC; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  14 days after enrollment (Day 15)

Secondary Outcomes (3)

• Evaluation of change in clinical condition based on the 7-point ordinal scale

  day of enrollment and 15 days after enrollment

• Evaluation of change in clinical condition based on the 7-point ordinal scale and Responder Status

  day of enrollment, 8 days, 22 days and 29 days after enrollment

• Hospital resource utilization comparison

  29 days after enrollment, 85 days after enrollment

Study Arms (2)

Cenicriviroc (CVC)

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Cenicriviroc (CVC) DRUG

Treatment with Cenicriviroc tablets of 150mg. (450g/300g on day 1 and 300mg/d on days 2-28).

Also known as: Cenicriviroc Mesylate

Cenicriviroc (CVC)

Placebo DRUG

Optically identical pills without CVC.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• No participation in other clinical trials according to the German Medicines Act (AMG) (3 months before) at the time of this trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Allergan: collaborator

Study Sites (1)

Medical Department of Hepatology and Gastroenterology, Charité University Medicine, Campus Virchow Klinikum (CVK) and Campus Charité Mitte (CCM)

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

COVID-19

Interventions

cenicriviroc

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Frank Tacke, Prof. Dr.med.

  Charité University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med., PhD, MHBA

Model Details: 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)

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 5, 2020
• Study Start: August 25, 2020
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

DE (1)