NCT04421027已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,525
- 试验地点
- 96
- 主要终点
- Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])
研究概览
简要总结
The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with 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
- Double (Participant, Investigator)
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
- •Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:
- •PCR positive in sample collected <72 hours prior to randomization; OR
- •PCR positive in sample collected ≥72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •Requires supplemental oxygen at the time of study entry and at randomization.
- •Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation >ULN within 2 days before study entry.
排除标准
- •Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
- •Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-
- •Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
- •Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
- •Have received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab for COVID-
- •Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
- •Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
- •Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
- •Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry.
- •Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
- •Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
- •Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry.
- •Have neutropenia (absolute neutrophil count <1000 cells/microliters).
- •Have lymphopenia (absolute lymphocyte count <200 cells/microliters).
- •Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN.
- •Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
- •Have a known hypersensitivity to baricitinib or any of its excipients.
- •Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (started) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day
- •Are pregnant, or intend to become pregnant or breastfeed during the study.
- •Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
- •Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.
研究组 & 干预措施
Baricitinib + Standard of Care (SOC)
Experimental
4 milligrams (mg) of baricitinib (given as two 2 mg tablets) administered orally every day (QD) with standard of care.
干预措施: Baricitinib (Drug)
Placebo + SOC
Placebo Comparator
Placebo (given as two placebo tablets) administered orally QD with standard of care.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])
时间窗: Day 1 to Day 28
Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2
时间窗: Day 1 to Day 28
Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.
次要结局
- Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital(Day 10)
- Number of Ventilator-Free Days(Day 1 to Day 28)
- Time to Recovery(Day 1 to Day 28)
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4(Day 4)
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7(Day 7)
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10(Day 10)
- Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14(Day 14)
- Duration of Hospitalization(Days 1 to Day 28)
- Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline(Day 10)
- Overall Mortality(Day 1 to Day 28)
- Duration of Stay in the Intensive Care Unit (ICU) in Days(Day 1 to Day 28)
- Time to Clinical Deterioration (One-category Increase on the NIAID-OS)(Day 1 to Day 28)
- Time to Resolution of Fever in Participants With Fever at Baseline(Day 1 to Day 28)
- Time to Independence From Non-Invasive Mechanical Ventilation(Day 1 to Day 28)
- Time to Independence From Oxygen Therapy in Days(Day 1 to Day 28)
- Mean Change From Baseline on the National Early Warning Score (NEWS)(Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14)
- Number of Days With Supplemental Oxygen Use(Day 1 to Day 28)
- Number of Days of Resting Respiratory Rate <24 Breaths Per Minute(Day 1 to Day 28)
- Time to Definitive Extubation(Day 1 to Day 28)
研究者
研究点 (96)
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