Plasma From Individuals Who Have Recovered From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection as Treatment for Acute COVID-19 Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Disease progression
研究概览
简要总结
There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness.
详细描述
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-19. However, data is limited to small studies and case series on severely ill patients. The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease. Plasma is collected from consenting donors who have recovered from SARS-CoV-2.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and <81 years
- •Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- •Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of >20 breaths per minute without supplemental oxygen treatment
- •A 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 and the Rh system is required)
- •Unavailability of plasma
- •Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- •Disease duration >8 Days
- •Estimated glomerular filtration rate <60 (kidney failure stage III or more)
- •Pregnancy (urinary-hcg), breast feeding,
- •History of severe allergic reactions
- •Inability to give informed consent
- •Significantly compromised immunity.*
- •Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (TNF) agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.
结局指标
主要结局
Disease progression
时间窗: 28 days
Decrease in progression to requiring non-invasive or invasive ventilation
次要结局
- Inflammatory parameter Pro-calcitonin(Until discharged from the hospital, up to 2 months)
- Time ro resolution of fever and symptoms(Until discharged from the hospital, up to 2 months)
- Clearance of viraemia(Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.)
- Antibody response to SARS-CoV-2(Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.)
- Inflammatory parameter C-reactive protein (CRP)(Until discharged from the hospital, up to 2 months)
- Inflammatory parameter white blood cell count(Until discharged from the hospital, up to 2 months)
- Adverse events (AE)(The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.)
- Inflammatory parameter haemoglobin (Hb)(Until discharged from the hospital, up to 2 months)
- Inflammatory parameter Creatine Kinase(Until discharged from the hospital, up to 2 months)
研究者
Joakim Dillner
Professor of Infectious Disease Epidemiology; Director of R&D
Karolinska University Hospital