A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Influenza Caused by Type A Strains
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The occurence of Adverse Events
研究概览
简要总结
The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.
详细描述
The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult subjects who are hospitalized with influenza caused by Type A strains. Approximately 450 subjects will be enrolled at study centers in North America, Europe, and other regions.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older at the time of screening. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States, Data Privacy Directive in Europe) obtained from the subject/legal representative prior to performing any protocol related procedures, including screening evaluations.
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must have evidence of not being pregnant upon enrollment and have a negative pregnancy test prior to administration of investigational product. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), premenarchal, or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Hospitalized ≤ 72 hours prior to receipt of a positive diagnostic test for influenza A; confirmed with positive rapid antigen test (supplied or approved by the sponsor), or confirmed with culture, polymerase chain reaction, or antigen testing at the study site. Onset of influenza symptoms ≤ 144 hours (≤ 6 days) prior to randomization. Receiving supplemental oxygen. Expected to participate in the study through Day 60.
排除标准
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of study drugs or interpretation of subject safety or study results.
- •Concurrent enrollment in another clinical study involving an investigational treatment. -Hospitalized > 72 hours (> 3 days) prior to receipt of a positive diagnostic test for influenza A.
- •Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor. -Receipt of any investigational antiviral medications within 30 days prior to study drug dosing.
- •Previous receipt of an influenza mAb within past 100 days.
- •Pregnant or nursing female.
- •History of allergic disease or reactions likely to be exacerbated by any components of the study drugs (MEDI8852 or oseltamivir).
- •Diagnosis of influenza B infection within 14 days prior to randomization.
- •Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
研究组 & 干预措施
Oseltamivir + low dose MEDI8852
Low Dose of MEDI8852 + Oseltamivir will be studied
干预措施: Oseltamivir (Drug)
Oseltamivir + low dose MEDI8852
Low Dose of MEDI8852 + Oseltamivir will be studied
干预措施: MEDI8852 (Drug)
Oseltamivir + high dose MEDI8852
High dose of MEDI8852 + Oseltamivir will be studied.
干预措施: Oseltamivir (Drug)
Oseltamivir + high dose MEDI8852
High dose of MEDI8852 + Oseltamivir will be studied.
干预措施: MEDI8852 (Drug)
Oseltamivir + Placebo
Oseltamivir in conjunction with placebo will be studied.
干预措施: Oseltamivir (Drug)
Oseltamivir + Placebo
Oseltamivir in conjunction with placebo will be studied.
干预措施: Placebo (Drug)
结局指标
主要结局
The occurence of Adverse Events
时间窗: Through Day 28
Occurrence of adverse events.
Evaluation of efficacy as defined as time to normalization of respiratory function.
时间窗: Through Day 14
To evaluate the effect of MEDI8852 administered in conjunction with oseltamivir and the effect of oseltamivir alone in reducing time to normalization of respiratory function.
The occurence of Serious Adverse Events
时间窗: Through Study Day 60
Occurrence of serious adverse events.
The occurence of Adverse Events of Special Interest (AESIs)
时间窗: Through Day 60
Occurrence of Adverse Events of Special Interest.
次要结局
- Evaluation of serum concentrations and PK of MEDI8852.(Through Day 60)
- Evaluation of serum ADA responses in serum through Day 60.(Through Day 60)
- Assessment of the effect of MEDI8852 in reducing severity of clinical status.(Through Day 7)
- Evaluation of time to hospital discharge.(Through Day 60)
- Quantitation of influenza viral shedding by qRT-PCR.(Through Day 60)
- Evaluation of time to ICU discharge.(Through Day 60)
- Evaluation of the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities.(Through Day 14)
- Evaluation of Change in NEWS from baseline through Day 14.(Through Day 14)
- Evaluation of the effect of MEDI8852 in reducing the duration of mechanical ventilation.(Through Day 60)
- Evaluation of the effect of MEDI8852 on all-cause re-admission rates during the study.(Through Day 60)
- Evaluation of the effect of MEDI8852 in reducing the rates of ICU admission from the general ward.(Through Day 60)
- Evaluation to determine the effect of MEDI8852 on all-cause mortality(Through Day 60)