NCT04343976终止2 期
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected With COVID-19
Raymond Chung1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年6月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Undetectable COVID PCR at Day 7
研究概览
简要总结
Prospective randomized trial to assess the antiviral efficacy of Pegylated Interferon Lambda (180 mcg SC injection) vs.placebo in up to 20 subjects with COVID-19 infection.
详细描述
The study objective is to assess the efficacy of Pegylated Interferon Lambda (180 mcg) vs. placebo in inducting quantitative PCR negativity at day 7
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
- Single (Participant)
盲法说明
Single blind
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
- •Able to provide informed consent
- •Confirmed COVID-19 diagnosis based on PCR analysis of respiratory secretions
- •Positive SARS-CoV-2 RT-PCR test must be within 48 hours of randomization
排除标准
- •Clinically-significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol
- •Treatment with IFN or other immunomodulatory/immunosuppressive agent within 12 months before screening.
- •Respiratory compromise requiring ventilatory support other than nasal cannula (mask, bipap or intubation and mechanical ventilation)
- •History of treatment with any of the following medications within five half-lives or 30 days before administration of the study drug (whichever is longer): anti-IL-6, anti-IL6R antagonists, Janus kinase inhibitors, ustekinumab (anti-IL-12/23), or anti IL-23 agents (guselkumab).
- •Life threatening SAE during the screening period
- •Pregnant or Nursing Females
- •Platelet count <90,000 cells/mm3
- •WBC count <3,000 cells/mm3
- •ANC <1,500 cells/mm3
- •Hb <11 g/dL for women and <12 g/dL for men
- •CrCl < 50 mL/min
- •Bilirubin level ≥ 1.5x ULN
- •INR ≥1.5 (except in the setting of concomitant anticoagulant use)
- •CRP > 200 mg/L
- •Clinically-relevant alcohol or drug abuse within 12 months of screening
- •Known hypersensitivity to Interferons
- •Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through Day 14 post treatment
研究组 & 干预措施
Lambda Treatment
Experimental
Treatment with subcutaneous injection (180 mcg) of pegylated interferon lambda
干预措施: Pegylated interferon lambda (Drug)
Saline Placebo
Placebo Comparator
Subcutaneous injection of saline placebo
干预措施: Pegylated interferon lambda (Drug)
结局指标
主要结局
Undetectable COVID PCR at Day 7
时间窗: 7 days
Negative COVID PCR testing 7 days after first lambda dose
次要结局
- Undetectable COVID PCR Testing at Day 14(14 days)
- Undetectable COVID PCR at Day 3(3 days)
- Percentage of Subjects on Lambda vs Placebo With Symptomatic Improvement(2 weeks)
- Percentage of Subjects on Lambda vs Placebo With Improved Clinical Outcomes(2 weeks)
研究者
Raymond Chung
Director of Hepatology, MGH
Massachusetts General Hospital
研究点 (1)
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