Open, Non-comparative Pilot Study to Provide Access to Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection
研究概览
简要总结
This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.
详细描述
Primary objectives are as follows:
- To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection
- To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers.
Secondary, exploratory objectives are as follows:
- To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients
- To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion
- To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion
- Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)
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 must be 18 years of age or older.
- •Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
- •Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
- •For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.
排除标准
- •Female subjects with positive pregnancy test or breastfeeding.
- •Receipt of pooled immunoglobulin in past 30 days.
- •Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
- •On ECMO or in refractory shock at entry
研究组 & 干预措施
Convalescent Plasma
The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.
干预措施: Convalescent Plasma (Drug)
结局指标
主要结局
NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection
时间窗: Day of convalescent plasma infusion (day 0) and following day (day 1)
Neutralizing antibody titer (PRNT 80)
次要结局
- Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score(Within 4 hours of transfusion)
- Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples(Day 0,1,3,7 and 14)
研究者
Michelle Harkins
Division Chief of Pulmonary/ Critical Care/Sleep Medicine
University of New Mexico