Pharmacokinetics of a SARS-CoV-2 Monoclonal Antibody in Hematopoietic Stem Cell Transplant Recipients (COVIDMAB)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Half-life of Sotrovimab (VIR-7831) Post-transplant
研究概览
简要总结
This phase I trial studies the process by which sotrovimab is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics) in hematopoietic stem cell transplant recipients. Sotrovimab is a monoclonal antibody that may target and bind to a specific protein on SARS-CoV-2 and block its viral attachment and entry into human cells. This may slow the progression of the disease and accelerate recovery, and may potentially provide temporary protection against infection with SARS-CoV-2 in hematopoietic stem cell transplant recipients.
详细描述
OUTLINE:
Patients receive sotrovimab intravenously (IV) over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial.
After completion of study treatment, patients are followed up for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (or legally authorized representative if applicable) must be capable of understanding and providing a written informed consent
- •Patients must be at least 18 years of age, of any gender, race, or ethnicity
- •Patients must be undergoing HCT (any donor or stem cell source including autologous or cord blood)
- •History of prior transplants are permitted
- •History of COVID-19, history of vaccination for SARS-CoV-2, positive polymerase chain reaction (PCR) of a respiratory specimen for SARS-CoV-2 as long as it is not within four weeks from conditioning, or seropositivity for SARS-CoV-2 are permitted
- •History of SARS-CoV-2 infection or vaccination of the donor are permitted.
- •Post-enrollment vaccination is anticipated and permitted
- •Administration of intravenous immunoglobulin therapy (IVIG) before or during the study is permitted
排除标准
- •Signs or symptoms of uncontrolled, active infection
- •Positive PCR result for SARS-CoV-2 within four weeks of scheduled conditioning
- •Pregnant or breastfeeding (this population is generally not cleared for transplant)
- •Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
- •Previous anaphylaxis or severe hypersensitivity reaction, including angioedema, to a mAb
- •Previous reaction to a mAb that required medical attention
- •Participants of other clinical studies that preclude the use of other investigational compounds
- •Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol or unlikely to survive to the end of study
研究组 & 干预措施
Prevention (Sotrovimab)
Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial.
干预措施: Questionnaire Administration (Other)
Prevention (Sotrovimab)
Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial.
干预措施: Sotrovimab (Biological)
Prevention (Sotrovimab)
Patients receive sotrovimab IV over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Half-life of Sotrovimab (VIR-7831) Post-transplant
时间窗: Up to 24 weeks
Will use descriptive statistics of model estimation from population pharmacokinetic model. Levels of VIR-7831 can be measured using an idiotypic antibody assay that is not affected by COVID-19 infection or vaccination.
Neutralizing Antibody Titers
时间窗: Up to 24 weeks
Will be calculated by a one-phase exponential decay model. Will compare fold-changes in antibody titers by normalizing to pre-transplant levels for each subject. Data analysis was not performed.
次要结局
- Half-life of VIR-7831 in Matched vs Mismatched Donors(Up to 24 weeks)
- Half-life of VIR-7831 in Autologous vs Allogeneic HCT(Up to 24 weeks)
- VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea(Up to 24 weeks)
- VIR-7831 Exposure in Patients With and Without Graft Versus Host Disease(Up to 24 weeks)
- Number of Participants With Breakthrough SARS-CoV-2 Acquisition(Up to 24 weeks)
- Antibody Clearance Rate From Serum/Plasma(Up to 24 weeks)
- Number of Participants With Presence of Anti-drug Antibodies From Serum/Plasma(At 4 and 24 weeks)
- Number of Participants With Adverse Events(Up to 40 weeks)
研究者
Alpana Waghmare
Assistant Professor
Fred Hutchinson Cancer Center