SARS-CoV-2 infection
Conditions
Interventions
Product Name: Cenicriviroc
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CENICRIVIROC MESYLATE
CAS Number: 497223-28-6
Other descriptive name: CENICRIVIROC MESYLATE
Concentration unit:
Sponsors
Charité - Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures. 2. Male or non-pregnant female adult =18 years of age at time of enrolment. 3. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR (date of sample collection maximal 10 days prior to randomization) 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). 4. Scoring a “3” or “4” (or “5”, at the Investigator’s discretion) on the cited 7-Point Ordinal Scale at enrolment. o 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 5. No participation in other clinical trials according to AMG (3 months before) at the time of this trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. ALT/AST > 5 times the upper limit of normal. 2. Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B or C) 3. Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR < 30 ml/min) 4. Advanced cardiac (eg, severe heart failure [NYHA III-IV]) or pulmonary diseases which, in the Investigator's judgment, would not make participation appropriate. 5. Pregnancy or breast feeding. 6. Anticipated transfer to another hospital which is not a study site within 72 hours. 7. Known allergy or hypersensitivity to CVC or its components 8. Use of medications that are contraindicated with CVC and that could not be replaced or stopped during the trial period 9. Administration of specified drugs which interfere with the metabolism of CVC (see listing in protocol body for allowed or disallowed medication and CVC’s drug metabolism pathway (section 9.1.13) 10. Patients immediately or imminently requiring mechanical ventilation. 11. Patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons 12. Subjects who are legally detained in an official institution 13. Subjects that are unsuitable to understand or to comply with the study requirements or in the opinion of the investigator 14. Subjects who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to compare the efficacy of Cenicriviroc (CVC) plus standard of care (SOC) versus SOC alone in participants with COVID-19 with respect to achieving a meaningful response in clinical condition.;Secondary Objective: Key secondary and secondary objectives: 1. Evaluate the clinical efficacy of CVC relative to the control arm in patients hospitalized with COVID-19 with respect to improvement in clinical condition, as assessed by respiratory and laboratory assessments. 2. To compare hospital resource utilization in patients receiving CVC relative to the control arm in participants with COVID-19. 3. To compare respiratory progression in patients receiving CVC versus placebo in participants with COVID-19 [Daily assessment while inpatient] 4. Evaluate the safety of CVC as compared to the placebo ;Primary end point(s): 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints • 7-point ordinal scale to be assessed on Day 15 (and Day 1 for baseline comparison), analyses of: o ordinal improvement of 2 or more, compared with baseline o ordinal improvement of 1 or more, compared with baseline • with 7-point ordinal scale assessed on: Days 8, 22, 29 (and Day 1 for baseline comparison), analyses of: o Responder status (achieving a score of a “1” or a “2”) o ordinal improvement of 2 or more, compared with baseline o ordinal improvement of 1 or more, compared with baseline • Length of time spent in the hospital (days) • Length of time spent in the ICU (days) • Days alive and out of hospital through Day 29. • Days free of endotracheal tube-based ventilation (or ECMO) through Day 29 Secondary endpoints • 7-point Ordinal Scale outcome, assessed while hospitalized o Time to an ordinal improvement of 2 or more, compared with baseline (i.e. start of trial participation) o Time to an ordinal improvement of 1 or more, compared with baseline (i.e. start of trial participation) o Subject clinical status using ordinal scale at Days 3, 5, 8, 29, and 85 • National Early Warning Score (NEWS) assessed daily while hospitalized o The time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first. o Change from baseline to Days 3, 5, 8, 15, and 29 in NEWS • Duration of supplemental oxygen (if applicable) • Exogenous oxygen free days in the first 28 days (to Day 29). • Incidence of new oxygen use during the study • duration of new oxygen use during the study • Mechanical Ventilation: o Ventilator free days in the first 28 days (to Day 29). o Incidence and duration of new mechanic ventilation • Mortality o 14 -day mortality o 28-day mortality o 12-week mortality • Evaluate the safety of the intervention through 84 days of follow-up as compared to the control arm as assessed by: o Cumulative incidence of serious adverse events (SAEs) through Day 85 of follow-up. o Cumulative incidence of G | — |
Countries
Germany
Contacts
Public ContactDept. of Hepatology and Gastroenter
Charité - Universitaetsmedizin Berlin
Outcome results
None listed