NCT05007236已完成2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild SARS-CoV-2 Infection.
Rhizen Pharmaceuticals SA16 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2021年9月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 16
- 主要终点
- Proportion of patients requiring Covid-19 related hospitalization by Day 15.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study of RP7214 in patients with symptomatic mild SARS-CoV-2 infection, having at least one high-risk feature (e.g., age > 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity, cancer) for developing severe Covid-19 illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent.
- •Males and females of ≥ 18 years of age
- •Patient with mild COVID-19 infection having ≥ 1 symptoms.
- •Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
- •Patient should have at least one pre-existing high-risk feature for developing severe Covid-19 illness.
- •Ability to swallow and retain oral medication.
- •Male patient who is surgically sterile, or who is willing to agree to use a contraceptive measure.
- •Women of childbearing potential should be willing to use a medically acceptable method of contraception.
- •Willing to receive telephone calls or have videoconferences with study team personnel.
- •Willing and able to understand the nature of this study, comply with the study procedures and follow-up procedures as per the study protocol.
排除标准
- •Patient with asymptomatic Covid-19 infection.
- •Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time of randomization.
- •Moderate to Severe COVID-19 infection
- •Patient with Covid-19 re-infection
- •Subjects who are severely immunocompromised
- •Subjects with autoimmune diseases
- •Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
- •Current use of other DHODH inhibitors including teriflunomide or leflunomide.
- •Patients who are on or immediately require Covid-19 directed treatment such as antivirals, immunomodulatory treatment, convalescent plasma, oral/ intravenous steroids, or monoclonal antibodies at the time of screening.
- •Patients who have had received one or two doses of vaccine for Covid-
- •Patients participating in another clinical study or use of any investigational product within 4 weeks or 5 half-lives of the drug, whichever is longer, before the date of dosing
研究组 & 干预措施
Placebo + Standard of care (SOC)
Placebo Comparator
干预措施: Placebo + Standard of care (SOC) (Drug)
RP7214 + Standard of care (SOC)
Experimental
干预措施: RP7214 + Standard of care (SOC) (Drug)
结局指标
主要结局
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
时间窗: 15 days
次要结局
- Time to symptom resolution in patients receiving RP7214 as compared to placebo(15 days)
- Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.(15 days)
- Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test(15 days)
- Proportion of patients demonstrating symptom resolution(15 days)
- Time to symptom improvement in patients receiving RP7214 as compared to placebo(15 days)
- Proportion of patients demonstrating symptom improvement(15 days)
- Change in the disease-specific inflammatory markers (Ferritin, C-reactive protein (CRP), D-dimer, neutrophil to lymphocyte/CD8+ ratio, LDH, IL-6) as compared to baseline.(15 days)
研究者
研究点 (16)
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