Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,225
- 试验地点
- 58
- 主要终点
- Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization
研究概览
简要总结
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
详细描述
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •≥ 18 years of age
- •Competent and capable to provide informed consent
- •• Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab
- •Experiencing any symptoms of COVID-19 including but not limited to fever(T> 100.5º F), cough, or other COVID associated symptoms like anosmia
- •≤ 8 days since the first symptoms of COVID-19
- •≤ 8 days since first positive SARS-CoV-2 RNA test
- •Able and willing to comply with protocol requirements listed in the informed consent
排除标准
- •Hospitalized or expected to be hospitalized within 24 hours of enrollment
- •Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
- •History of prior reactions to transfusion blood products
- •Inability to complete therapy with the study product within 24 hours after enrollment
- •Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (monoclonal antibodies, compassionate use or study trial related). Steroid treatment at any time does not affect study eligibility
结局指标
主要结局
Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization
时间窗: Up to day 28
Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Cumulative Incidence of Severe Infusion Reactions
时间窗: Up to day 28
Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.
Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events
时间窗: Up to day 90
Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.
Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)
时间窗: Up to day 28
Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.
次要结局
- Serum SARS-CoV-2 Antibody Titers by Visit(Days 0, 14, 28 and 90)