EUCTR2020-002537-15-RO进行中（未招募）1 期
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS CoV 2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,970
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) =72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted =72 hours prior to randomization is acceptable.
- •Has symptoms consistent with COVID-19, as determined by investigator, with onset =10 days before randomization
- •Hospitalized for COVID-19 illness for =72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:
- •a. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
- •b. Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol
- •c.Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
- •d.Cohort 3: On mechanical ventilation
- •NOTE: Other protocol defined inclusion criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2079
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 891
排除标准
- •Key Exclusion Criteria:
- •Phase 1 only: Patients maintaining O2 saturation >94% on room air
- •In the opinion of the investigator, unlikely to survive for >48 hours from screening
- •Receiving extracorporeal membrane oxygenation (ECMO)
- •Has new-onset stroke or seizure disorder during hospitalization
- •Initiated on renal replacement therapy due to COVID-19
- •NOTE: Other protocol defined exclusion criteria apply
研究者
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