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

Shin Poong Pharm0 个研究点目标入组 1,420 人开始时间: 待定最近更新: 2022年5月30日

适应症

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 1,420

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19(Year) 至 o Limit（—）
性别: All

入选标准

•1)Adult males and females aged 19 years or older (or minimum age for adulthood or for informed consent below 19 years for each country)
•2)Patients with body weight =45 kg at screening
•3)Patients with COVID-19 confirmed by RT-PCR before randomization
•4)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
•5)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

•1)Patients with severe or critical* COVID-19
•* Severe (SpO2 <94% without oxygen supply, PaO2/FiO2<300 mmHg, respiratory rate >30 per minute, or pulmonary infiltration > 50%), or Critical (respiratory failure, shock, and/or multiple organ failure) requiring high-flow oxygen therapy, ventilator, multiorgan injury, ECMO, CRRT treatment
•2)Patients requiring hospitalization for therapeutic purposes for COVID-19 such as oxygen therapy or higher level of care , or who may be potentially transferred to another hospital other than the institution within 72 hours, with decreased oxygen saturation (<94%) at screening.
•3)Patients who have received or who have plans 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).
•* Drugs other than investigational product that may affect the treatment course of COVID-19
•?Other antiviral drugs (remdesivir, lopinavir/ritonavir, favipiravir, ribavirin, umifenovir, baloxavir marboxil) and therapeutic antibodies (bamlanivimab plus etesevimab, casirivimab plus imdevimab, sotrovimab, regdanvimab, etc.)
•?Hydroxychloroquine and/or azithromycin
•?Interleukin-6 inhibitor (tocilizumab, sarilumab, etc.) and interleukin-1 inhibitor
•?Interferon
•?Convalescent Plasma
•?Conventional intravenous immunoglobulin
•?Other antimalarial drugs (e.g., primaquine, dihydroartemisinin)
•4)Patients with one or more of the following infections in the past or present
•a.Infection with need for systemic anti-infection treatment other than COVID-19 (SARS-CoV-2)
•b. Serious infection with need for oral antibiotics or hospitalization within 30 days before administration of investigational product by discretion of the investigator.
•5)Patients with a known clinically significant anemia (Hemoglobin <8.0 g/dL)
•6)Patients with a known severe renal impairment (eGFR = 30 mL/min/1.73 m2)
•7)Patients with a known severe hepatic dysfunction
•ALT or AST =5 times upper limit of normal (ULN) or,
•Vomiting or abdominal pain associated with jaundice or,
•Child-Pugh stage B or C
•8)Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of investigational product
•9)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)
•10)Patients who cannot be orally administered investigational product
•11)Pregnant, breast-feeding or females with positive pregnancy test at screening
•12)Females and males who have a child-bearing plan or who are unwilling to commit to the use of the following methods of contraception* during the study period and for 3 months after the study period
•* Hormonal contraception (combination of estrogen and progesterone or progesterone monotherapy; subcutaneous implants, injections, oral, intravaginal contraceptives, etc.), intrauterine devices [intrauterine device (IUD), intrauterine hormone-releasing system (IUS)], barrier method that must be included spermicides (use of female contracep

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发起方

Shin Poong Pharm

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