A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Modified WHO Ordinal Scale (MOS) score
研究概览
简要总结
In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.
详细描述
Investigators are doing this research to learn more about high-titer COVID-19 convalescent plasma (HT-CCP) transfusion as a possible treatment for people who have COVID-19, the coronavirus infection. "HT-CCP" is plasma that contains a high amount of antibodies that were made to fight off COVID-19 because it is donated by another person who has also been infected with coronavirus but has recovered, so their immune system has had enough time to make these antibodies. This study is being done to determine whether HT-CCP will help people with COVID-19 recover from their infection more quickly and lower their risk of having to go on a ventilator or reduce the time they need to stay on a ventilator. It is not yet known whether HT-CCP helps people with COVID-19, which is why the study needs to be randomized, meaning some subjects will be randomly selected to receive HT-CCP while others will be randomly selected to receive FFP.
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, Investigator)
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >1 year.
- •Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
- •Meets institutional criteria for admission to hospital for COVID-
- •Admitted to ICU or non-ICU floor within 5 days of enrollment.
- •PaO2/FiO2 >200 mmHg if intubated.
- •Patient or LAR able to provide informed consent.
排除标准
- •Previous treatment with convalescent plasma for COVID-
- •Current use of investigational antiviral therapy targeting SARS-CoV-
- •History of anaphylactic transfusion reaction.
- •Clinical diagnosis of acute decompensated heart failure.
- •Objection to blood transfusion.
结局指标
主要结局
Modified WHO Ordinal Scale (MOS) score
时间窗: Day 14
The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.
次要结局
未报告次要终点
研究者
Kaufman, Richard Max,M.D.
Principal Investigator
Brigham and Women's Hospital