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临床试验/NCT04545060
NCT04545060已完成2 期

A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients

Vir Biotechnology, Inc.1 个研究点 分布在 1 个国家目标入组 1,057 人开始时间: 2020年8月27日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
1,057
试验地点
1
主要终点
Number of Participants Who Had Progression of COVID-19 Through Day 29
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old
  • •Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms

排除标准

  • •Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
  • •Symptoms consistent with severe COVID-19
  • •Participants who, in the judgement of the investigator are likely to die in the next 7 days
  • •Severely immunocompromised participants

研究组 & 干预措施

VIR-7831 (Sotrovimab)

Experimental

Participants received 500 mg sotrovimab administered intravenously (IV)

干预措施: VIR-7831 (sotrovimab) (Biological)

Placebo

Placebo Comparator

Participants received placebo administered intravenously (IV)

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Participants Who Had Progression of COVID-19 Through Day 29

时间窗: Through Day 29

COVID-19 progression defined as hospitalization \>24 hours or death

次要结局

  • Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Number of Participants With Adverse Events (AEs)(Up to 24 weeks)
  • Number of Participants With Cardiac Events of Special Interest(Up to 24 weeks)
  • Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Number of Participants With Serious Adverse Events (SAEs)(Up to 24 weeks)
  • Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions(Up to 24 weeks)
  • Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab(Up to 24 Weeks)
  • Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Mean Change in FLU PRO Plus Total Score (AUC)(Through Day 7)
  • Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8(Through Day 8)
  • Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab(Up to 24 weeks)
  • Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Number of Participants Who Had Progression of COVID-19(Through Day 29)
  • Time to Symptom Alleviation Using FLU-PRO Plus(Through Day 21)
  • Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22(Through Day 22)
  • Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29(Through Day 29)
  • 90-day All-cause Mortality(Through Day 90)
  • Clearance (CL) of VIR-7831 After IV Administration(Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169)
  • Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8(Baseline and Day 8)
  • Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15(Through Day 15)
  • 29-day All-cause Mortality(Through Day 29)
  • 60-day All-cause Mortality(Through Day 60)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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