Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy
研究概览
简要总结
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients.
In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Admitted to a study hospital
- •Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- •Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
- •Written informed consent after meeting with a study physician and ability and willingness to complete follow up
排除标准
- •No matching plasma donor (Exact matching in both the ABO system is required)
- •Unavailability of plasma
- •Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- •Estimated glomerular filtration rate <60 (kidney failure stage III or more)
- •Pregnancy (urinary-hcg)
- •Breast feeding
- •History of severe allergic reactions to foods or other substances that the donor may have been exposed to (for example severe peanut allergy)
- •Inability to give informed consent
结局指标
主要结局
Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy
时间窗: Measured in the first 28 days after inclusion.
Progression to non-invasive or invasive ventilation or a sustained requirement of 15L of supplementary oxygen therapy in patients that are not eligible for intensive care treatment.
次要结局
- Adverse events(The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.)
- Dose of plasma needed to clear viremia(28 days)
- Clearance of viremia(6 months.)
- Fever and symptoms(Until discharged from the hospital, up to 2 months)
- Inflammatory parameters(Until discharged from the hospital, up to 2 months)
- Antibody response to SARS-CoV-2(6 months)
研究者
Joakim Dillner
Professor of Infectious Disease Epidemiology; Director of R&D
Karolinska University Hospital