KCT0005834已完成未知
A Multi-center, Randomized, Double-blind, Parallel, Placebo-Controlled, Phase ? Clinical Trial to Evaluate Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients
Shin Poong Pharm0 个研究点目标入组 110 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 110
研究概览
简要总结
A
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1)Male and Female adult age over 19
- •2)The weight over 45 kg at screening.
- •3)Persons confirmed by COVID19 as a result of real-time reverse transcription polymerase chain reaction (rRT-PCR) test using specimens collected from upper airway (oropharyngeal/ nasopharyngeal smear mixing, etc.) or lower airway (sputum, etc.) within 72 hours of randomization.
- •4)Persons whose oxygen saturation in blood (SpO2) > in indoor air condition at randomization.
- •5)A person who agrees in writing to voluntarily decide to participate and follow the precautions after hearing and fully understanding the details of this study.
排除标准
- •1)Persons who are diagnosed with severe pneumonia#
- •#Suspected respiratory infections with one of the followings
- •Breathing more than 30 times/minute, severe dyspnea, oxygen saturation (SpO2) 93% or less without oxygen administration
- •2)Persons with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation)
- •3)Persons with clinically significant anemia (Hemoglobin <8.0 g/dL)
- •4)Persons who have hypersensitivity to main ingredients (pyronaridine phosphate, artesunate) and components of the investigational product
- •5)Persons who have problems like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •6)Persons who have gastrointestinal disease or surgical patient that may affect absorption, distribution, metabolism and excretion of drugs, current active gastritis, gastrointestinal /rectal bleeding, gastric ulcers, pancreatic abnormalities such as pancreatitis, etc. (except simple appendectomy or hernia surgery)
- •7)Persons who have received antiviral drugs for the treatment of COVID19 infection within 28 days prior to participation in the study (However, if sufficient wash-out period has elapsed, it is possible to participate in the study)
- •8)Patients with severe renal impairment (eGFR = 30 mL/min/1.73 m2)
- •9)Patients with severe hepatic impairment (ALT or AST = 5 times the normal upper limit of the trachea or have symptoms of abdominal pain or vomiting associated with Jaundice or Child-Pugh Stage B or C)
- •10)Virus diseases other than COVID19 that requires administration of other antiviral agents (HIV, HBV, HCV etc.)
- •11)Patients requiring mechanical ventilation (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation etc.)
- •12)Patients with chronic underlying diseases(such as uncontrolled diabetes, chronic kidney disease, chronic liver disease, chronic lung disease, chronic cardiovascular disease, blood cancer, cancer patients with anti-cancer treatment, patients taking immunosuppressants, etc.), patients with high obesity, dialysis patients, transplant patients whom are inadequate to participate in clinical trials based on the investigator’s discretion.
- •13)Pregnant women or breastfeeding mothers
- •14)Women and men of childbearing potential who plan to become pregnant or unwilling to use the appropriate contraception during the study and within 3 months after completion of the study
- •*Hormonal contraception (subcutaneous implants, injection, oral contraceptives, etc.), intrauterine devices(copper IUD, intrauterine systems containing hormones), all use of double-blocking methods (male (condom) and female (contraceptive diaphragm, vaginal sponge or cervical cap), sterilization procedure(vasectomy, ligation of uterine tube, etc.)
- •15)A person who participated in another clinical trial / medical device clinical trial within 28 days from the date of signing the consent and received drug / operated medical device for clinical trial.
- •16)A person who has been determined that it is inappropriate to participate in this study for any other reasons by the investigator.
研究者
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