NCT04475107已完成2 期
A Multi-center, Randomized, Double-blind, Parallel, Placebo-Controlled, Phase Ⅱ 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
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 13
- 主要终点
- Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
研究概览
简要总结
This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase Ⅱ 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
- •Age ≥19 years at the time of signing Informed Consent Form
- •Body weight ≥45 kg at screening
- •Laboratory (rRT-PCR) confirmed infection with SARS-CoV-2 by testing specimens from upper airway (i.e. nasopharyngeal and oropharyngeal swab) or lower airway (i.e. sputum) within 96 hours of randomization
- •Oxygen saturation(SpO2) > 94% at randomization, in room air condition
- •Willing and able to provide informed consent
排除标准
- •Diagnosed with severe pneumonia
- •Patients with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation)
- •Patients with clinically significant anemia (Hemoglobin <8.0 g/dL)
- •Patient with known allergic reaction or contraindication to any of the investigational medicinal product (pyronaridine tetraphosphate, artesunate)
- •Patients with known history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
- •Patients with the gastrointestinal disease and surgery to affect the absorption, distribution, metabolism and excretion of the drug, active gastritis, gastrointestinal tract / rectal bleeding, gastric ulcer, pancreatitis abnormalities (except simple appendectomy or hernia surgery)
- •Patients who received antiviral drugs that is intended to treat COVID-19, within 28 days prior to screening evaluation (can be enrolled into the study, if the patient has gone through a sufficient wash-out period)
- •Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
- •Patients with known severe liver disease (i.e. ALT or AST>5 times upper limit, nausea, abdominal pain associated with jaundice or Child-Pugh stage B or C)
- •Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of other antiviral agents
- •Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.)
- •Patients with chronic underlying disease (e.g. uncontrolled diabetes mellitus, chronic kidney disease, chronic liver disease, chronic pulmonary disease, chronic cardiovascular disease, blood cancer, cancer patients with cancer treatment, patients taking immunosuppressants), highly obese patients, dialysis patients, and transplant patients that are determined by the Physician, to be not suitable for trial involvement.
- •Pregnant or lactating women
- •Male or female of childbearing potential who has plans to become pregnant during the study period and for three months after the clinical study or who is not willing to take appropriate contraceptive measures
- •*Hormonal contraception (contraceptive implant, injections, pills, etc.), IUDs, condoms (male) and contraceptive diaphragm or cap (female), sterilization (vasectomy, tubal ligation, etc.)
- •Participating in another clinical trial currently or within 28 days from signing the informed consent
- •Patients that are deemed ineligible to participate in the clinical trial by the Investigator
研究组 & 干预措施
Arm A
Experimental
Pyramax (Pyronaridine 180mg/ Artesunate 60mg)
干预措施: Pyronaridine-Artesunate (Drug)
Arm B
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
时间窗: Day 7
\* Patients who are rRT-PCR negative for COVID-19
次要结局
- Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline(Day 3, 7, 10, 14, 28)
- Time to achieve normalization of oxygen saturation, post-dose(Day 3, 7, 10, 14, 28)
- Time to achieve normalization of body temperature, post-dose(Day 3, 7, 10, 14, 28)
- Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline(Day 3, 7, 10, 14)
- Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*(Day 3, 10, 14)
- Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline(Day 3, 7, 10, 14, 28)
- Time to achieve normalization of respiratory rate, post-dose(Day 3, 7, 10, 14, 28)
研究者
研究点 (13)
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