NCT05216588已完成不适用
Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies with Early Access Authorization in Immunocompromised Patients. a Prospective Cohort.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Neutralizing antibody activity
研究概览
简要总结
This prospective cohort of patients, receiving pre exposure prophylaxis by Anti-SARS-CoV-2 Monoclonal Antibodies, is designed to evaluate the treatment protection against SARS-CoV-2 variants of concerns
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults (18 years-old or more)
- •Patient who received the first administration of Evusheld at 300 mg for less than 4 months and should receive a second dose, according to French recommendations OR Patient scheduled to receive or having received less than a month ago an injection of anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg, according to the French SARS-CoV-2 RT recommendations
- •qPCR negative at baseline
- •SARS-CoV-2 RT-qPCR Negative at inclusion
- •Patients who remain seronegative after a complete COVID-19 vaccination schedule
- •Immunocompromised patients :
- •Hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient : kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor
- •Life expectancy > 3 months
- •Social security affiliation
- •Lack of a legal protection measure
- •Signed informed consent
排除标准
- •Participation to another clinical study
- •State medical aid
- •Ongoing or scheduled plasmapheresis or immunoadsorption
- •Pregnant / lactating woman
- •Patient whose isolation period is underway following contact with a confirmed case of SARS-CoV2 infection
- •Hypersensitivity to one of the active substances or to one of the excipients
结局指标
主要结局
Neutralizing antibody activity
时间窗: Month 12
次要结局
- Proportion of patients with SAE(Month 12)
- Proportion of patients with suspended prophylaxis due to adverse event(Month 12)
- Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2(Month 12)
- Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.(Month 12)
- Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period(Month 12)
- Proportion of patients with treatment AE(Month 12)
- Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection(Month 12)
- Severity of treatment AE(Month 12)
- Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies(Month 12)
- Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2(Month 12)
- Anti-S et Anti- N antibodies levels(Month 12)
- Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it(Month 12)
- Proportion of patients infected with a resistant variant(Month 12)
研究者
研究点 (1)
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