EUCTR2020-006044-14-PL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + SOC vs. placebo + SOC in adult hospitalized patients with COVID19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,501
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
- •Main Study:
- •All the following criteria need to be met for inclusion:
- •1. Men and women =18 years of age at the time of consent.
- •2. Laboratory-confirmed diagnosis of COVID-19.
- •3. Hospitalized for COVID-19 related respiratory disease.
- •4. Patient belongs to one of the following four categories in the nine-point COVID-19 severity scale:
- •Hospitalized, not requiring supplemental oxygen –Level 3 of the nine-point COVID-19 severity scale.
- •Hospitalized, requiring supplemental oxygen – Level 4 of the nine-point COVID-19 severity scale.
- •Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both – Level 5 of the nine-point COVID-19 severity scale.
- •Hospitalized, requiring intubation and mechanical ventilation- Level 6 of the nine-point COVID-19 severity scale.
- •5. For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local
- •regulations) during the study period.
- •6. Informed consent obtained from any patient capable of giving consent, or, when the patient is not capable of giving consent, from his or her legal/authorized representatives.
- •Sub (Exploratory) Study:
- •All the inclusion criteria of the Main Study with the following substitution for inclusion criterion (4):
- •Hospitalized, requiring ventilation for more than 5 days or intubation + additional organ support – pressors, RRT, ECMO - Level 7 of the nine-point COVID-19 severity scale.
- •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 975
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 526
排除标准
- •Patients will be excluded if any of the following criteria are met:
- •1. The subject is a female who is breastfeeding or pregnant.
- •2. Known hypersensitivity to EB05 or its excipients.
- •3. In the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment.
- •4. Active participation in other immunomodulator or immunosuppressant drug clinical trials.
- •participation in COVID-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case by case basis.
- •5. Treatment with immunomodulator or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, antiIL-1 agents, and JAK inhibitors within 5 half-lives or 30 days
- •(whichever is longer) before randomization. (Note treatment with
- •immunomodulator or immunosuppressant drugs, such as
- •corticosteroids, as part of SOC, is permitted).
- •6. Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgement of the clinician.
研究者
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