NCT04528368Unknown2 期
Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
D'Or Institute for Research and Education1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
研究概览
简要总结
The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient Inclusion Criteria:
- •Confirmed diagnosis of COVID-19 by RT-PCR;
- •Time between symptom onset and inclusion ≤ 7 days;
- •Chest tomography with <50% involvement of the lung parenchyma;
- •No indication of ventilatory support at the time of randomization;
- •Sign the consent form.
排除标准
- •Contraindication to transfusion or history of previous reactions to blood products for transfusion;
- •Pregnant women;
- •Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
- •Donor Inclusion Criteria for Plasmapheresis:
- •Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
- •SARS-COV-2 negative RT-PCR;
- •Asymptomatic for at least 14 days;
- •SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;
- •Sign the consent form.
- •Donor Exclusion Criteria:
- •Female gender with previous pregnancy;
- •Absence of peripheral venous network compatible with the apheresis procedure;
- •Positive or indeterminate result in any of the infectious screening tests;
- •Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.
结局指标
主要结局
Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
时间窗: 0, 3, 6, 9, 12, 15, 18 and 21 days
To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.
次要结局
- Length of stay in intensive care(21 days)
- Assess the rate of orotracheal intubation(21 days)
- Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)(0, 3, 6, 9, 12, 15, 18 and 21 days)
- Change in the profile of cytokines/chemokines in both groups(0, 3, 6, 9, 12, 15, 18 and 21 days)
- Assessment of clinical improvement using an Ordinal Severity Scale(0, 7, 10, 14, 21 and 28 days)
- Assess respiratory rate(0, 3, 6, 9, 12, 15, 18 and 21 days)
- Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration(0, 3, 6, 9, 12, 15, 18 and 21 days)
- Death rate(7, 10, 14, 21 and 28 days)
- Evaluate oxygen saturation(0, 3, 6, 9, 12, 15, 18 and 21 days)
- Evaluate oxygen supplementation(0, 3, 6, 9, 12, 15, 18 and 21 days)
- Length of hospital stay(21 days)
- Rate of transfusion reactions to convalescent plasma infusion(21 days)
研究者
研究点 (1)
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