A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
研究概览
简要总结
This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
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
- •Subjects Age ≥ 18 Willing and able to provide written informed consent
- •SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
- •Time of illness onset ≥8 days
- •Have findings consistent with interstitial lung disease found on CT scan
- •Willing not use other investigational agents of anti-fibrosis
排除标准
- •Pre-existing severe liver disease
- •Pre-existing severe chronic kidney disease
- •Pre-existing interstitial lung disease
- •Pre-existing severe COPD or other structural lung disease
- •Receiving invasive mechanical ventilation
- •Currently Pregnant or Breast Feeding
- •Poor baseline health conditoin
- •Disability to complete lung function test
- •Receiving pirfenidone wthin half-year
研究组 & 干预措施
Pirfenidone
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
干预措施: Pirfenidone Oral Product (Drug)
Placebo
Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months
干预措施: Pirfenidone placebo (Drug)
结局指标
主要结局
To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
时间窗: 1 month
1. Change of total lung lesion volume on Chest CT from enrollment to 1 month follow up 2. DLCO% pred at 1 month follow up
次要结局
- difference of DLCO between two groups(at the 3 months follow-up vist)
- incidence of adverse event(within 2 months after enrollment)
- difference of total lung capacity (TLC) between two groups(at the 1 month and 3 months follow-up vist)
- Medical Research Council (mMRC) dyspnoea scale(at the 1 month and 3 months follow-up vist)
- distance walked in 6 Minutes (6MWD)(at the 1 month and 3 months follow-up vist)
- the EuroQol five-dimension five-level (EQ-5D-5L)(at the 1 month and 3 months follow-up vist)
- difference of forced vital capacity (FVC) between two groups(at the 1 month and 3 months follow-up vist)
研究者
Bin Cao
Capital Medical University
Capital Medical University