RPCEC00000379招募中1 期
Exploratory, controlled, randomized, open and monocentric clinical trial to evaluate the safety and explore the antiviral effect of anti-SARSCoV-2 gamma globulin in Sars-Cov-2 adult serious with COVID-19. - GammaCOVID-AICA
AICA Laboratorories Company0 个研究点目标入组 30 人开始时间: 2021年6月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 19 years 至 one（—）
- 性别
- All
入选标准
- •1. Severe patients over 19 years of age, with a confirmed diagnosis by PCR-RT of infection by the SARS-CoV-2 virus.
- •2. Patients with less than 10 days of evolution since the onset of symptoms.
- •3. Patient who gives his informed consent.
排除标准
- •1. Ventilated
- •2. With acute and chronic kidney disease
- •3. Previous thromboembolic events
- •4. History of previous anaphylaxis
- •5. Previous history of adverse reaction to intravenous gamma globulin
- •6. Pregnant or lactating woman
- •7. Severe comorbidity: terminal cancer and severe heart disease.
- •8. Body Mass Index (BMI) = 30
- •9. With a diagnosis of selective IgA immunodeficiency
- •10. With autoimmune diseases
- •11. That they are using treatment with the anti-CD 6 monoclonal antibody Itolizumab
- •12. History of having received treatment with blood products one month before inclusion in the study.
研究者
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ithium Carbonate-COVID-19- mild and moderate -Exploratory / Phase IICOVID-19SARS-CoV2BetacoronavirusCoronaviridae InfectionsCoronavirus InfectionsSARS VirusRPCEC00000386Institute of Basic and Preclinical Sciences Victoria de Giron192
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