跳至主要内容
临床试验/RBR-7hzhwd
RBR-7hzhwd终止2 期

A phase IIb, double blind and randomized controlled study to evaluate the efficacy and safety of the Ivermectin in patients with Serious Acute Respiratory Syndrome during the Covid-19 pandemic

Hospital de Base de São José do Rio Preto0 个研究点开始时间: 2020年5月20日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Intervention

入排标准

年龄范围
18Y 至 90(—)

入选标准

  • Men or women, 18 years of age or older, ability to provide informed consent signed by study patient or legally acceptable representative
  • Respiratory sign or symptom, cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, O2 saturation less than 93%, signs of cyanosis, nasal flaring, accessory muscle use, and dyspnea).
  • Need for oxygen support using a nasal catheter up to 6 l / min to keep SaO2 above 94% or SpO2 less than 94% in room air.
  • Proven diagnosis of Covid-19 using a molecular diagnostic assay based on polymerase chain reaction.
  • Requires hospitalization in the ward.
  • Less than seven days after the first flu-like symptom.

排除标准

  • Suspected infections suggestive of fungal or bacterial etiologies.
  • Chronic hepatitis C infection in antiviral therapy.
  • Severely immunocompromised in the investigator's opinion (eg, differentiation cluster count 4+ [CD4 +] less than 200 cells / mm3, absolute neutrophil count less than 750 / mm3, first chemotherapy cycle completed within 2 weeks prior to screening, history stem cell transplantation within the period of 1 year prior to screening, any history of solid ORG transplant).
  • Pregnant women, Category C
  • Patients with a life expectancy of less than 30 days
  • Patients with meningitis or other disorders of the Central Nervous System that may affect the blood-brain barrier

研究者

发起方
Hospital de Base de São José do Rio Preto

相似试验

进行中(未招募)
1 期
Respiratory syncytial virus (RSV) investigational vaccine in infants aged 6 and 7 months likely to be unexposed to RSV
EUCTR2018-000431-27-PLGlaxoSmithKline Biologicals176
进行中(未招募)
1 期
A study to evaluate safety and immunogenicity of GSK Biologicals' RSV investigational vaccine in RSV-seropositive infants aged 12 to 23 months.Active immunization of infants for the prevention of any lower respiratory tract infections (LRTIbronchiolitis and [broncho]pneumonia) associated with respiratory syncytial virus (RSV [subtypes A and B])MedDRA version: 21.1Level: LLTClassification code 10035692Term: Pneumonia due to respiratory syncytial virusSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10038718Term: Respiratory syncytial virus bronchiolitisSystem Organ Class: 10021881 - Infections and infestations
EUCTR2016-000117-76-ITGLAXOSMITHKLINE BIOLOGICALS96
进行中(未招募)
1 期
A study to evaluate safety and immunogenicity of GSK Biologicals' RSV investigational vaccine in RSV-seropositive infants aged 12 to 23 months
EUCTR2016-000117-76-ESGlaxoSmithKline S.A.107
进行中(未招募)
1 期
Respiratory syncytial virus (RSV) investigational vaccine in infants aged 6 and 7 months likely to be unexposed to RSVActive immunization of infants for the prevention of any lower respiratory tract infections (LRTIbronchiolitis and [broncho] pneumonia) associated with respiratory syncytial virus (RSV).
EUCTR2018-000431-27-GBGlaxoSmithKline Biologicals176
进行中(未招募)
1 期
A study to evaluate safety and immunogenicity of GSK Biologicals’ RSV investigational vaccine in RSV-seropositive infants aged 12 to 23 months.Active immunization of infants for the prevention of any lower respiratory tract infections (LRTIbronchiolitis and [broncho]pneumonia) associated with respiratory syncytial virus (RSV [subtypes A and B])MedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10038718Term: Respiratory syncytial virus bronchiolitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10035692Term: Pneumonia due to respiratory syncytial virusSystem Organ Class: 10021881 - Infections and infestations
EUCTR2016-000117-76-PLGlaxoSmithKline Biologicals96