Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
研究概览
简要总结
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
详细描述
COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 0 to 22 years of age
- •SARS-CoV-2 infection documented by RNA RT-PCR detection
- •Admitted to an acute care facility
- •Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived
排除标准
- •Pregnancy/ breast feeding
- •Medical condition that increases the risk of plasma infusion
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- •Inclusion criteria for infusion:
- •Severe COVID-19 disease, OR
- •Moderate disease with a risk of progression to severe or life threatening disease, OR
- •Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care.
- •Exclusion to infusion:
- •Pregnancy/ breast feeding
- •Medical condition that increases the risk of plasma infusion
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
研究组 & 干预措施
Convalescent Plasma (CP)
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered
干预措施: Convalescent Plasma (CP) (Biological)
Convalescent Plasma (CP)
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered
干预措施: Standard COVID-19 therapies (Drug)
结局指标
主要结局
Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
时间窗: 28 days
Safety of convalescent plasma for pediatric patients will be determined by capturing the grade 3-5 adverse events that are possible, probably or definitely related to the CP infusion, defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
- Change in percent of supplemental oxygen(Baseline, 72 hours after infusion)
- Number of patients that required change in level of respiratory support(Baseline, 72 hours after infusion)
- Mortality(up to 1 year)
- Mean length of ICU stay (days)(Up to 28 days)
- Mean length of hospital stay (days)(Up to 28 days)
- Mean length of ventilation (days)(Up to 28 days)
- Number of patients with progression to renal dysfunction and/or multisystem organ failure(up to 1 year)
- IL-6 level(up to 28 days)
- Number of anti-SARS CoV 2 specific T cells(up to 28 days)
- Diversity of circulating T cells(up to 28 days)
- ARS-CoV-2 Antibody Titer(up to 28 days)
- SARS-CoV-2 Neutralizing Titer(up to 28 days)
研究者
Preeti Jaggi
Principal Investigator
Emory University