Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE SAFETY AND EFFICACY OF TOFACITINIB IN HOSPITALIZED PARTICIPANTS WITH COVID-19 PNEUMONIA WHO ARE RECEIVING STANDARD OF CARE THERAPY
The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pneumonia who are receiving SoC therapy and who are not on HFNC, noninvasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.
Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available or public health assay, who have agreed to participate will be screened within 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1.
Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate.
Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET/ED/EOT visit, and on Day 60.
An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.
研究概览
研究类型
阶段
- 阶段2
联系人和位置
学习地点
-
-
Connecticut
-
Hartford、Connecticut、美国、06102
- Hartford Hospital (HH)
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- University of Iowa
-
Iowa City、Iowa、美国、52242
- University of Iowa Hospitals & Clinics Investigational Drug Services
-
-
Louisiana
-
Shreveport、Louisiana、美国、71103
- LSUHSC-Shreveport
-
Shreveport、Louisiana、美国、71103
- Ochsner LSU Health Shreveport Academic Medical Center
-
-
Ohio
-
Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female between 18 and 65 years. A female is eligible if she is not pregnant or breastfeeding. WOCBP must use 2 highly effective forms of contraception.
- Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection prior to Day 1.
- Participants with evidence of COVID-19 pneumonia assessed by radiographic imaging (chest x ray or chest CT scan).
Exclusion Criteria:
- Require HFNC, non-invasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.
- Have history of or current thrombosis. Only if current thrombosis is suspected, imaging testing is recommended (e.g. CTPA or per local guidance) to exclude thrombosis.
- Have a personal or first degree family history of blood clotting disorders.
- Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (e.g. azathioprine, cyclosporine).
- Participants with any current malignancy or lymphoproliferative disorders that requires active treatment.
- Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19).
- Severe hepatic impairment, defined as Child-Pugh class C.
- Severe anemia (hemoglobin < 8 g/dL)
- ANY of the following abnormalities in clinical lab tests at screening, confirmed by a single repeat, if deemed necessary: ALC < 500 cells/mm3, ANC < 1000 cells/mm3
- Known allergy to tofacitinib
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tofacitinib
Participants will receive tofacitinib 10 mg twice per day for 14 days and standard of care therapy.
|
10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days
其他名称：
|
|
安慰剂比较：Placebo
Participants will receive tofacitinib-matching placebo twice per day for 14 days and standard of care therapy.
|
Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical status using ordinal scale
大体时间：Day 28
|
Death or respiratory failure (1, 2, or 3, on an 8-point ordinal scale of disease severity) at Day 28.
The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
|
Day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical status using ordinal scale
大体时间：Day 14
|
Ordinal scale of disease severity.
The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
|
Day 14
|
|
Status of alive and not using mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
大体时间：Day 14 and Day 28
|
Category 3 to 8 on an ordinal scale of disease severity.
The scale is as follows: 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
|
Day 14 and Day 28
|
|
Status of discharged or not requiring supplemental oxygen
大体时间：Day 28
|
Category 5 to 8 on an ordinal scale of disease severity.
The scale is as follows: 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
|
Day 28
|
|
Mortality
大体时间：Day 60
|
Category 1 on an ordinal scale of disease severity.
The scale is as follows: 1) Death.
|
Day 60
|
合作者和调查者
赞助
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- A3921377
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.