NCT04610541Unknown3 期
Open-label Study to Assess the Safety of REMdesivir-HU as Eligible Novel therapY for Moderate and Severe Covid-19 Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 2,000
- 试验地点
- 7
- 主要终点
- To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA)
研究概览
简要总结
This is a Phase 3, open-label, multi-center, interventional safety study of REM therapy in participants 12 years of age or older with COVID-19, pneumonia and oxygen supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 12yrs and older with body weight at least 40kg
- •Hospitalized with COVID-19 confirmed by PCR and/or COVID-19 typical symptoms with pneumonia:
- •▪ In case of no confirmed PCR test result available at screening, typical symptoms can also apply
- •requiring supplemental oxygen at screening
- •▪ at the discretion of the investigator, any form of O2 support can apply
- •Do not have access to Veklury treatment
- •▪ Patient may be under other treatment against COVID-19 (except for chloroquine/hydroxychloroquine)
- •Willing and able to provide valid written informed consent prior to performing study procedures (for those <18yrs of age, parental consent and patient assent is required). For an unconscious or comatose patient written informed consent given by next of kin or a legal representative is also accepted. If none of the above consents are available the investigator can enroll the patient as described in 21 CFR 50.24 (involving emergency research).
排除标准
- •Known liver disease, hepatic impairment and/or Alanine Transaminase (ALT) or Aspartate Transaminase (AST) ≥ 5 times the upper limit of normal
- •Known severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (eGFR) < 30 ml/min.
- •Pregnancy or breast feeding at the discretion of the investigator
- •Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours
- •Know allergy to any anti-viral medication
- •Hypersensitivity to the active substance(s) or to any of the excipients
- •Current (or 48 hours prior) treatment with chloroquine/hydroxychloroquine Other investigationsl treatment up to 2x the "emptying" time of treatment, or if this is not known for 60 days, except in the case of a favipiravir study. In case of the clinical trial of favipiravir the petinents can be enrolled in the study if afterthe end of study / early termination visit.
- •Any medical condition that the examining physician deems unsuitable for the patient to participate in the study.
研究组 & 干预措施
Remdesivir-HU
Experimental
Day 1 - single loading dose of remdesivir-HU 200 mg given by intravenous infusion
• Day 2 onwards - 100 mg given once daily by intravenous infusion.
干预措施: Remdesivir-HU (Drug)
结局指标
主要结局
To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA)
时间窗: 30 days
The primary endpoint of the study is the proportion of patients with at least one treatment-emergent AESI (hypersensitivity including infusion-related reaction, anaphylactic reaction, acute respiratory failure, hypotension, hepatic toxicity and nephrotoxicity).
次要结局
- The proportion of patients with at least 1 treatment-emergent adverse event(30 days)
- Proportion of patients with treatment-emergent clinical(30 days)
研究者
研究点 (7)
Loading locations...
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