Created at Source Raw Value Validated value
June 2, 2022, 8 a.m. oms

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 ? Steroid ? 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

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 ? Steroid ? 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