A Phase 2, Multi-Center, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 4
- 主要终点
- Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
研究概览
简要总结
This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).
详细描述
There are few effective therapies for coronavirus disease 2019 (COVID-19) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS-CoV). Small clinical trials and observational studies of CP therapy in patients with COVID-19 have suggested a possible clinical benefit.
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
- Double (Participant, Outcomes Assessor)
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
- •Willing and able to provide written informed consent prior to performing study procedures or have a legally authorized representative available to do so.
- •Age ≥18 years
- •Evidence of SARS-CoV-2 infection by PCR test of naso-/oro-pharyngeal swab or tracheal aspirate sample within 14 days of randomization
- •Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation at screening
- •Evidence of infiltrates on chest radiography
- •Females of childbearing age and males, must be willing to practice an effective contraceptive method or remain abstinent during the study period.
排除标准
- •Participation in another clinical trial of anti-viral agent(s) for COVID-19
- •Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 <24 hours prior to study drug administration [1]
- •Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days
- •Severe multi-organ failure
- •History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria
- •Known Immunoglobulin A (IgA) deficiency
- •Females who are pregnant
- •Use of remdesivir as treatment for COVID-19 is permitted.
研究组 & 干预措施
Convalescent Plasma (anti-SARS-CoV-2 plasma)
Convalescent plasma (1 unit; ~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
干预措施: Convalescent Plasma (anti-SARS-CoV-2 plasma) (Biological)
Non-convalescent Plasma (control plasma)
Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019
干预措施: Non-convalescent Plasma (control plasma) (Biological)
结局指标
主要结局
Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
时间窗: Up to 28 days
Compare the day 28 severity outcome amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups using a 7-point ordinal scale of clinical status. Seven-point ordinal scale for clinical assessment ranges from 1 and 2: Not hospitalized 3: Hospitalized, not requiring supplemental oxygen 4: Hospitalized, requiring supplemental oxygen 5: Hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation 6: Hospitalized, requiring IMV, ECMO, or both 7: Dead Higher number means worse outcome
次要结局
- Proportion of SARS-CoV-2 PCR Positivity(Up to 14 days)
- Levels of SARS-CoV-2 RNA(Up to 14 days)
- Duration of Need for Supplemental Oxygen(Up to 28 days)
- Duration of Hospitalization(Up to 28 days)
- 28-day Mortality(Up to 28 days)
- Time-to-clinical Improvement In-hospital(Up to 28 days)
- Host Genetic Differences at Day 0(Day 0)
- Host Transcriptomic Differences at Days 0,7,14(Up to 14 days)
研究者
Max O'Donnell
Florence Irving Associate Professor of Medicine and Epidemiology
Columbia University