EUCTR2020-001493-29-DE进行中（未招募）1 期
Charité trial of Cenicriviroc (CVC) treatment for COVID-19 patients - CVC for COVID-19
Charité - Universitaetsmedizin Berlin0 个研究点目标入组 200 人开始时间: 2020年4月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •oNote, 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
排除标准
- •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
研究者
相似试验
进行中（未招募）
1 期
The study of an investigational drug, Cenicriviroc, for the treatment of Nonalcoholic Steatohepatitis (NASH).onalcoholic Steatohepatitis with fibrosisMedDRA version: 20.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2014-003164-21-DETobira Therapeutics, Inc., a subsidiary of Allergan plc252
进行中（未招募）
1 期
The study of an investigational drug, Cenicriviroc, for the treatment of Nonalcoholic Steatohepatitis (NASH).EUCTR2014-003164-21-FRTobira Therapeutics, Inc.252
进行中（未招募）
1 期
The study of an investigational drug, Cenicriviroc, for the treatment of Nonalcoholic Steatohepatitis (NASH).onalcoholic Steatohepatitis with fibrosisMedDRA version: 17.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2014-003164-21-ESTobira Therapeutics, Inc.252
进行中（未招募）
1 期
The study of an investigational drug, Cenicriviroc, for the treatment of Nonalcoholic Steatohepatitis (NASH).onalcoholic Steatohepatitis with fibrosisMedDRA version: 20.0 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disordersEUCTR2014-003164-21-GBTobira Therapeutics, a subsidiary of Allergan plc289
进行中（未招募）
1 期
The study of an investigational drug, Cenicriviroc, for the treatment of Nonalcoholic Steatohepatitis (NASH).EUCTR2014-003164-21-BETobira Therapeutics, Inc., a subsidiary of Allergan plc289