RBR-5r8gv8p暂停2 期
Antibodies in Covid-19 therapy: phase IIa clinical study with convalescent plasma and generation of human monoclonal antibodies
niversidade de Brasília0 个研究点开始时间: 2021年7月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 0（—）
入选标准
- •Plasma donor: be between 18 and 60 years old; be male or a female that has never been pregnant; weight at least 60 kg; have SARS-CoV-2 infection confirmed by positive RT-PCR; be eligible for blood donation, according to the appropriate Brazilian law (Seção II da Portaria de Consolidação n.5, de 28 de setembro de 2017); agree to participate in the study and sign the informed consent form(s); have no Covid-19 symptoms for 14-27 days, in which case a new RT-PCR test from a nasopharyngeal or oropharyngeal swab has to be negative OR have no Covid-19 symptoms for 28 days or more, in which case no additional tests are necessary; have a positive result on a SAR-CoV-2 IgG test. Plasma transfusion receptor: be 18 years or older; have been admitted to a hospital to treat moderate Covid-19, defined as compatible clinical characteristics, such as dyspnea and/or fever and/or cough plus chest computed tomography with bilateral ground glass opacities; have SARS-CoV-2 infection confirmed by nasopharyngeal and/or oropharyngeal swab PCR or serological assay that detects IgM or SARS-CoV-2 antigen; have Covid-19 symptoms for no more than 10 days.
排除标准
- •Plasma donor: at the interview and research subject selection stage: history of severe Covid-19 in the last 30 days (septic shock, cardiac arrest or intubation for more than two days); previous history of coagulation diseases than could increase the venous access risk; previous history of hemoglobinopathies that could increase the plasmapheresis risk; situations that prohibit blood donations, according to Brazilian law (Portaria de Consolidação n.5, de 28 de setembro de 2017). At the pre-plasmapheresis stage: positive result in an irregular antibody test made with serum collected during triage; detection of anomalous hemoglobin (e.g. sickle cell trait) in a whole blood sample obtained during triage; negative result on a test for SARS-CoV-2 IgG; ineligibility for blood donation identified during triage, as specified at the relevant Brazilian law (Portaria de Consolidação n.5, de 28 de setembro de 2017). Plasma transfusion receptor: respiratory insufficiency with indication for mechanical ventilation; severe sepsis or septic shock; active co-infection with a dengue virus, confirmed by serological detection of the NS1 antigen or RT-PCR; admission to the Intensive Care Unit (ICU); having received intravenous immunoglobulin (IVIG) in the last 30 days; history of allergy or hypersensitivity to a blood product transfusion; heart or renal insufficiencies that makes the excess volume from plasma transfusion not advisable; in women, present pregnancy, plans to get pregnant in the following two months or breastfeeding; be part of another clinical trial.
研究者
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