The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients (Phase3)

Inclusion criteria

• 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

Exclusion criteria

• 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