NCT04992273终止2 期
A Phase 2A, Open-Label Study Assessing Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Single-Dose Subcutaneous Anti- Spike(s) SARS-COV-2 Monoclonal Antibodies (Casirivimab and Imdevimab) in High-Risk Pediatric Subjects Under 12 Years of Age
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- Concentrations of Casirivimab+Imdevimab in Serum Over Time.
研究概览
简要总结
The primary objective of the study is to characterize the concentrations of casirivimab+imdevimab in serum over time after a single subcutaneous (SC) administration
The secondary objectives of the study are:
- To assess the safety and tolerability of SC or single administration of casirivimab+imdevimab
- To assess the occurrence of grade ≥3 injection site reactions and grade ≥3 hypersensitivity reactions, in participants treated with SC doses of casirivimab+imdevimab
- To assess the immunogenicity of casirivimab+imdevimab
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is <12 years of age and ≥3 kg to <40 kg at the time parental/guardian consent is signed
- •Has at least one risk factor for developing severe COVID-19 if they were to become infected, such as:
- •Obesity (BMI [kg/m2] ≥95th percentile for age and sex based on CDC growth charts)
- •Cardiovascular disease
- •Chronic lung disease
- •Type 1 or type 2 diabetes mellitus
- •Chronic kidney disease, including those on dialysis
- •Chronic liver disease
- •Immunocompromised or immunodeficient, based on Investigator's assessment (examples include cancer treatment, bone marrow or organ transplantation, immune deficiencies, HIV infection, sickle cell anemia, thalassemia, and prolonged use of immune-weakening medications)
- •Medical complexities (examples include any underlying genetic condition, neurologic condition, metabolic condition, or congenital heart disease)
- •Any other condition deemed by the Investigator to be a risk factor for severe COVID-19
排除标准
- •Has positive diagnostic test for SARS-CoV-2 infection from a sample collected during screening ≤7 days prior to study drug administration Note: The sample for the test should be collected ≤7 days within study drug administration, and the result should be reviewed and confirmed negative prior to dosing. Historical records will not be accepted.
- •Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
- •Has subject-reported clinical history of COVID-19, as determined by Investigator, within the last 90 days
- •Has subject-reported history of prior Emergency Use Authorization (EUA)/approved positive diagnostic test for SARSCoV-2 infection within the last 90 days
- •Is currently hospitalized or was hospitalized for >24 hours for any reason within 14 days of the screening visit
- •Prior use (within 90 days prior to study drug administration) or current use of any investigational, authorized, or approved passive antibody for prophylaxis of SARS-CoV-2 infection, including convalescent plasma, convalescent sera, hyperimmune globulin, or other monoclonal antibodies (eg, bamlanivimab and etesevimab, sotrovimab)
- •Has initiated vaccination for SARS-CoV-2 with an investigational or approved vaccine, but has not completed the vaccine schedule as recommended by the vaccine manufacturer.
- •Plans to receive an investigational or approved SARS-CoV-2 vaccine within 90 days after study drug administration, or per the recommended time frame from the current Centers for Disease Control vaccination guidelines (CDC, 2021b)
- •NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
研究组 & 干预措施
≥20 kg to <40 kg
Experimental
SC administration
干预措施: casirivimab+imdevimab (Drug)
≥10 kg to <20 kg
Experimental
SC administration
干预措施: casirivimab+imdevimab (Drug)
≥5 kg to <10 kg
Experimental
SC administration
干预措施: casirivimab+imdevimab (Drug)
≥3 kg to <5 kg
Experimental
SC administration
干预措施: casirivimab+imdevimab (Drug)
结局指标
主要结局
Concentrations of Casirivimab+Imdevimab in Serum Over Time.
时间窗: Day 0 and Day 14
Concentrations reported in milligrams per Liter (mg/L)
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Through end of study, approximately 24 weeks)
- Number of Participants With Indicated Immunogenicity as Measured by Anti-drug Antibodies (ADA) to Casirivimab Over Time(Up to 24 weeks)
- Immunogenicity as Measured by Neutralizing Antibodies (NAb) to Casirivimab Over Time(Up to 24 weeks)
- Immunogenicity as Measured by NAb to Imdevimab Over Time(Up to 24 weeks)
- Number of Participants With Indicated Immunogenicity as Measured by ADA to Imdevimab Over Time(Up to 24 weeks)
- Number of Participants With Indicated Severity of TEAEs(Through end of study, approximately 24 weeks)
- Number of Participants With Grade ≥3 Injection Site Reactions(Through Day 4)
- Number of Participants With Grade ≥3 Hypersensitivity Reactions(Through Day 4)
研究者
研究点 (7)
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