临床试验/NCT04340232

NCT04340232撤回2 期

Safety and Efficacy of Baricitinib for COVID-19

University of Colorado, Denver1 个研究点分布在 1 个国家开始时间: 2021年3月最近更新: 2021年3月8日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: University of Colorado, Denver
试验地点: 1
主要终点: Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs)

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 study plans to learn more about the effects of a medicine called baricitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Baricitinib is FDA-approved for the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define the impact of baricitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs.

The study will recruit patients who have been diagnosed with COVID-19.

The goal is to recruit 80 patients.

详细描述

This is an adaptive Phase 2/3 clinical trial, with a focus on the assessment of safety in the first 20 participants (Phase 2), followed by a much broader assessment of efficacy, while continuing to monitor safety, in an additional 60 participants (Phase 3, total participants across Phase 2/3 n=80). Both phases are single arm, open label, and occur at a single site at the University of Colorado Hospital (UCH). Data from participants in this study will be compared with data from other COVID-19 patients not receiving baricitinib. Study participants will receive 2 mg/day of baricitinib for 14 days and will be followed for up to 29 days.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 89 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female aged 18 - 89 years at time of enrollment
•Hospitalized (or documented plan to hospitalize if patient is in the emergency department) with symptoms suggestive of COVID-19
•Illness of any duration that meets each of the following:
•Evidence of pneumonia, including radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or clinical assessment (rales/crackles on exam)
•Requires supportive care, including non-invasive supplemental oxygen
•Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay within 7 days of enrollment
•Understands and agrees to comply with planned study procedures
•Provides informed consent signed by study patient or legally acceptable representative

排除标准

•Absolute lymphocyte count is less than 500 cells/mm
•Absolute neutrophil count is less than 1000 cells/mm
•Hemoglobin level is less than 8 g/dL
•Estimated GFR is less than 60 mL/min/1.73 m2
•ALT or AST is over 5 times the upper limit of normal
•Treatment with other JAK inhibitors, OAT3 inhibitors, biologic disease-modifying anti-rheumatic drugs (DMARDs), anti-IL-6 or anti-IL-6R antibodies, or potent immunosuppressants such as azathioprine. and cyclosporine concurrently or within the past 5 days. Note: recent or concurrent treatment with hydroxychloroquine or chloroquine is allowable, as these are 'non-biologic' DMARDs with potential antiviral activity.
•History of HIV infection and on active immunosuppressant therapy
•Current hematological or solid organ malignancy and on active immunosuppressant therapy
•Active tuberculosis (TB) infection or known or suspected systemic bacterial or fungal infection
•Pregnancy or breast feeding
•Known allergy to baricitinib
•In the opinion of the investigator, they are unlikely to survive for >48 hours from screening
•Any physical examination findings and/or history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
•Additional Exclusion Criteria for Phase 2 only:
•Invasive oxygen supplementation, including mechanical ventilation and extracorporeal membrane oxygenation (ECMO)

研究组 & 干预措施

Baricitinib Arm

Experimental

This study is an Adaptive Phase 2/3 trial designed to test the safety (Phase 2) and efficacy (Phase 2 and 3) of baricitinib to treat COVID-19. Phase 2 consists of a single-arm, open-label assignment of 20 participants receiving 2 mg baricitinib once daily for 14 days. Phase 3 consists of a single-arm, open-label assignment of 60 additional participants receiving baricitinib at the same dose. In both phases, participants will be monitored daily while hospitalized for 29 days, or until discharge, whichever occurs first. Participants who are discharged will be followed up with via phone on Day 15 and Day 29.

干预措施: Baricitinib (Drug)

结局指标

主要结局

Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs)

时间窗: Day 0 (screening) through Day 29

Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. AEs will be collected and graded daily and cumulative incidence will be reported.

Phase 2: Changes in ALT through Day 15

时间窗: Day 1 to Day 15

Phase 2: Cumulative incidence of serious adverse events (SAEs)

时间窗: Day 0 (screening) through Day 29

Description: An SAE is defined as an AE that is life-threatening or results in death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs will be collected and graded daily and cumulative incidence will be reported.

Phase 2: Changes in total bilirubin through Day 15

时间窗: Day 1 to Day 15

Phase 2: Changes in hemoglobin through Day 15

时间窗: Day 1 to Day 15

Phase 2: Changes in glucose through Day 15

时间窗: Day 1 to Day 15

Phase 2: Changes in creatinine through Day 15

时间窗: Day 1 to Day 15

Phase 2: Changes in prothrombin time (PT) through Day 15

时间窗: Day 1 to Day 15

Phase 2: Changes in white blood cell count (CBC) through Day 15

时间窗: Day 1 to Day 15

Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as standard of care (SOC). Mean changes from baseline to Day 15 will be reported.

Phase 2: Changes in platelets through Day 15

时间窗: Day 1 to Day 15

Phase 2: Changes in AST through Day 15

时间窗: Day 1 to Day 15

Phase 2: Changes in white blood cell count (CBC) through End of Study (EOS)

时间窗: Day through Day 29 or hospital discharge, whichever is first

Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.

Phase 2: Changes in hemoglobin through End of Study (EOS)