NCT05084911已完成3 期
A Multi-center, Randomized, Double-blind, Parallel, Placebo-Controlled, Phase III Clinical Trial to Evaluate Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,807
- 试验地点
- 66
- 主要终点
- Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
研究概览
简要总结
This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase III clinical trial to evaluate efficacy and safety of pyramax in mild to moderate COVID-19 patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged 19 years or older (or minimum age for adulthood or for informed consent below 19 years for each country)
- •Patients with body weight ≥45 kg at screening
- •Patients with COVID-19 confirmed by RT-PCR before randomization
- •Patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days before randomization, who do not need adjunctive oxygen therapy
- •Patients who are fully informed of this study, voluntarily decide to participate in this study and provide written consent to comply with requirements for this study
排除标准
- •Patients with severe or critical* COVID-19
- •Patients requiring hospitalization for therapeutic purposes for COVID-19 such as oxygen therapy with a decrease of oxygen saturation (<94%) at screening or higher level of care, or who may be potentially transferred to another hospital other than the clinical trial institution within 72 hours.
- •Patients who have received or who have planned to receive any anti-viral drugs to treat COVID-19 infection or medications that may affect the course of treatment within 28 days before participating in this study or before a sufficient wash-out period [more than five times the half-life of the drug, etc.] (the longer period between the two is chosen).
- •Patients with one or more of the following infections in the past or present
- •Infection with need for systemic anti-infection treatment other than Corona virus (SARS-CoV-2)
- •Major infection with need for oral antibiotics or hospitalization within 30 days before administration of the investigational product by discretion of the investigator.
- •Patients with a known clinically significant anemia (Hemoglobin <8.0 g/dL)
- •Patients with a known severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2)
- •Patients with a known severe hepatic dysfunction
- •Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of the investigational product
- •Patients with a gastrointestinal disease or who underwent a surgery that can affect the absorption, distribution, metabolism and excretion of the drug, or who have active gastritis, gastrointestinal tract/rectal bleeding, gastric ulcer, and pancreatitis or pancreatic function abnormalities (excluding general appendectomy or hernia repair surgery)
- •Patients who cannot be orally administered with the Investigational Product
- •Pregnant, breast-feeding or females with positive pregnancy test at screening
- •Females and males who have child-bearing plan or who are unwilling to commit to the use of the following methods of contraception* during study period and for 3 months after the study period
- •Patients who have participated in another clinical study/device study and received the investigational product/device within 28 days from signing the informed consent
- •Patients with Co-morbidity requiring surgery within 7 days before administration of the investigational product, or life-threatening co-morbidity within 30 days before administration of the investigational product
- •Patients with history of alcohol or drug abuse within 12 months before administration of the investigational product
- •Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons
研究组 & 干预措施
Test
Experimental
Pyramax tablet
干预措施: Pyramax (Drug)
Control
Placebo Comparator
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
时间窗: follow up to Day29
次要结局
- Percentage of subjects requiring acute therapy for more than 24 hours in a hospital or acute treatment facility or who have died due to COVID-19 until D29 after administration(follow up to Day29)
- Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14(Day2, Day3, Day5, Day7, Day14)
- Time to sustained recovery (discharge) in hospitalized subjects (days)(follow up to Day29)
- NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline(Day3, Day7, Day14, Day21, Day29)
- 11-point WHO clinical progression scale for clinical symptoms at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline(Day3, Day7, Day14, Day21, Day29)
- 29-day mortality after the first dose of the investigational product(Day29)
- Percentage of subjects who have newly diagnosed with pneumonia or aggravated pneumonia* according to baseline pneumonia criteria until D29 after administration of the IP(follow up to Day29)
- Percentage of subjects in the high-risk group** who require hospitalization or have died due to COVID-19 until post-dose D29(follow up to Day29)
研究者
研究点 (66)
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