A Phase II Randomized, Double-blind Study to Evaluate the Safety, Neutralizing Activity and Efficacy of AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants Having an Increased Risk for Inadequate Response to Active Immunization (NOVELLA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 116
- 试验地点
- 7
- 主要终点
- The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
研究概览
简要总结
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
The aim of the Phase II study is to evaluate the safety, neutralizing activity and efficacy of AZD3152 for pre exposure prophylaxis of COVID-19
详细描述
Phase II study to assess the safety, neutralizing activity and efficacy of one dose of AZD3152 compared with one dose of placebo in adults with immunocompromised conditions, including comorbidities contributing to weakened immunity, thereby increasing the risk of COVID-19 progression up to severe grade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Participant must be 18 years of age or older at the time of signing the informed consent.
- •Weight ≥ 45 kg at Visit
- •Participants must satisfy at least 1 of the following risk factors at enrollment:
- •Obese, ie, BMI ≥ 30
- •Congestive heart failure
- •Chronic obstructive pulmonary disease
- •Chronic kidney disease
- •Intolerant of vaccine
- •Immunocompromised state (one of the following risk factors ):
- •Have cancer
- •Have solid organ transplant or a hematopoietic stem cell transplant
- •Are actively taking immunosuppressive medicines
- •Received chimeric antigen receptor T-cell therapy
- •Within 1 year of receiving B-cell depleting therapies
- •Have a moderate or severe primary immunodeficiency
- •Medically stable
- •WOCBP must not be pregnant or lactating and must use a highly effective method of contraception
排除标准
- •Known hypersensitivity to any component of the study intervention
- •Previous hypersensitivity or severe adverse reaction following administration of a mAb
- •Acute or febrile infection prior to dosing
- •Has HIV infection
- •Receipt of any convalescent COVID-19 plasma treatment, mAb against SARS-CoV-2 , COVID-19 vaccine within 6 months
- •COVID-19 antiviral prophylaxis within at least 2 weeks
- •COVID-19 case within 6 months
结局指标
主要结局
The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
时间窗: up to Day 181
The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
次要结局
- Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)(up to Day 181)
- Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)(up to Day 181)
- Incidence of a Post-treatment Symptomatic COVID-19 Case(up to Day 181)