EUCTR2020-001162-12-IT进行中（未招募）1 期
An adaptive phase 2/3, randomized, double-blind, placebo-controlled, study assessing efficacy and safety of sarilumab for hospitalized patients with COVID-19
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
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
- •Participants must have severe disease, multi-system organ dysfunction or critical disease
- •Laboratory-confirmed SARS-CoV-2 infection
- •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 184
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 276
排除标准
- •Unlikely to survive for >48 hours from screening
- •Presence of neutropenia less than 2000/mmˆ3, AST or ALT greater than 5 X ULN, platelets less than 50,000/mmˆ3
- •Prior immunosuppressive therapies
- •Use of chronic oral corticosteroids for non-COVID-19 related condition
- •Past or current history of autoimmune or inflammatory disease(s)
- •Known or suspected history of tuberculosis
- •Suspected or known active systemic bacterial or fungal infections
研究者
相似试验
进行中（未招募）
1 期
Sarilumab COVID-19Corona virus infectionMedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-001162-12-ESSanofi-aventis Recherche et Développement420
进行中（未招募）
1 期
Sarilumab COVID-19Corona virus infectionMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-001162-12-FRSanofi-aventis Recherche et Développement460
进行中（未招募）
1 期
Sarilumab COVID-19Corona virus infectionMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-001162-12-DESanofi-aventis Recherche et Développement440
进行中（未招募）
1 期
A Phase II/III study of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo in participants with recurrent or metastatic head and neck cancerRecurrent/Metastatic Head and Neck Squamous Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864EUCTR2019-002263-99-IEGlaxoSmithKline Research & Development Ltd315
进行中（未招募）
1 期
A Phase II/III study of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo in participants with recurrent or metastatic head and neck cancerEUCTR2019-002263-99-ATGlaxoSmithKline Research & Development Ltd600