Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe Coronavirus Disease 2019 Infectious Disease (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Serious adverse events in convalescent plasma treated patients
研究概览
简要总结
This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.
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
- 是
入选标准
- •for donors:
- •male patients who have been tested positive for SARS-CoV2 at University Hospital Basel, Switzerland or in the near surroundings more than 10 days before enrolment
- •18-60 years of age
- •asymptomatic (thus successfully overcome COVID-19) >14 days back
- •two consecutive naso-pharyngeal swabs tested negative for quantitative PCR-test for SARS-CoV-2 prior to plasma donation to demonstrate infection Resolution, or more than 28 days asymptomatic after SARS-CoV2 infection
- •Body weight of at least 50 kg
- •donor eligibility criteria according to the Swiss Red Cross Blood Transfusion Service as for regular blood donation
排除标准
- •for donors:
- •Female donors are excluded from plasma donation
- •Treatment with Actemra® (Tocilizumab) in the course of COVID-19
- •Current hospitalization
- •Current or previous relevant medical conditions that pose a risk for the donor
- •Inclusion Criteria for COVID-19 infected patients:
- •SARS-CoV-2 infection confirmed by PCR in respiratory secretions (naso- pharyngeal swab, broncho-alveolar lavage, sputum)
- •hospitalized
- •pulmonary infiltrates compatible with COVID-19 on CT-scan
- •availability of blood group compatible convalescent plasma
- •signed informed consent
结局指标
主要结局
Serious adverse events in convalescent plasma treated patients
时间窗: From baseline (enrolment) to 24 hours follow-up
Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection
Transfer to ICU
时间窗: at Baseline (admission to Covid-ward) until day 28
Transfer to ICU
Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients
时间窗: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Change in SARS-CoV2 quantitative in nasopharyngeal swab
Virologic clearance in plasma of convalescent plasma treated patients
时间窗: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Change in SARS-CoV2 quantitative in plasma
in-hospital death
时间窗: at Baseline (admission to Covid-ward) until day 28
in-hospital death
次要结局
- Humoral immune response(at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28)
- Time to discharge from hospital after enrolment(at Baseline (admission to Covid-ward) until discharge (approx. 28 days))