A Phase 2a Randomized, Dose Ranging, Double-Blind, 3-Arm Study to Investigate Orally Administered Abrocitinib Compared With Placebo in Non-Hospitalized Symptomatic Adult Participants With Severe Fatigue From Post COVID Condition
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale
研究概览
简要总结
The primary purpose of this phase 2a study is to compare the efficacy of abrocitinib to placebo in improving severe fatigue in non-hospitalized adults with symptomatic Post-COVID Condition (PCC) (also called Long COVID). We are also interested in learning if abrocitinib is effective in improving overall health status in people suffering from severe fatigue from PCC. Eligible participants with a confirmed history of COVID19 infection who also have PCC according to the World Health Organization definition, will be randomized to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo by mouth daily for 12 weeks (84 days).
详细描述
Eligible volunteers will participate in six in-person visits at Beth Israel Deaconess Medical Center over 5 months. These visits include review of medical and medication history, answering questionnaires, blood, urine, and nasal swab specimen collection, physical exams, and contraceptive and medication counseling.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of confirmed COVID-19 infection
- •PCC diagnosis according to the WHO definition as occurring in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 that lasts for at least 2 months and cannot be explained by an alternative diagnosis
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- •Capable of giving signed informed consent
排除标准
- •Participants with acute and chronic infections, history of specific recurrent infections
- •Suspected or confirmed active SARS-CoV-2 infection within past 30 days
- •Some cardiac conditions
- •Any current tobacco smoker or person who has smoked tobacco products within 12 months of screening, or former tobacco smoker ≥ 50 years old
- •Known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, Herpes Virus, or Tuberculosis
- •History of immunodeficiency
- •Blood clotting conditions
- •Must meet general screening laboratory criteria
- •Allergy or other contraindication to any of the components of the study intervention
- •Known prior participation in this trial or other trial involving abrocitinib
- •Concurrent therapy with a JAK or TYK2 inhibitor
- •Other protocol criteria apply
研究组 & 干预措施
Arm 1: Abrocitinib 50 mg daily
Participants will take 50 mg of abrocitinib daily for 12 weeks
干预措施: Placebo (Drug)
Arm 3: Placebo
Participants will take placebo daily for 12 weeks
干预措施: Placebo (Drug)
Arm 1: Abrocitinib 50 mg daily
Participants will take 50 mg of abrocitinib daily for 12 weeks
干预措施: Abrocitinib (Drug)
Arm 2: Abrocitinib 100 mg once daily
Participants will take 100mg of abrocitinib daily for 12 weeks
干预措施: Abrocitinib (Drug)
结局指标
主要结局
Change from baseline in mean score for FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale
时间窗: Baseline to Day 84
To compare the efficacy of abrocitinib to placebo in improving severe fatigue in adults with symptomatic PCC
次要结局
- Safety-related clinical laboratory test abnormalities and related adverse events(Baseline to Day 84)
- The difference in blood high sensitivity C-reactive protein (HSCRP) from baseline visit to Day 84(Baseline to Day 84)
- Change from baseline for EQ(EuroQol)-5D-5L values and visual analog scale (VAS) score to Day 84(Baseline to Day 84)
- Change from baseline in PASC Symptom PRO (patient reported outcome) Instrument score to Day 84(Baseline to Day 84)
研究者
Dan Barouch
Director of the Center for Virology and Vaccine Research
Beth Israel Deaconess Medical Center