Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

• Status: Completed
• Trial end date: 2022-11-20
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multi-center, single-arm, open-label, pilot clinical trial to explore efficacy and safety of Pyramax in mild to moderate COVID-19 patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd.
• Treatments: Artesunate; Pyronaridine

Criteria

Inclusion Criteria:

• Age 19 years or older

• Patients with body weight ≥45 kg at screening

• Patients who were first confirmed with COVID-19 through Real-Time Polymerase Chain Reaction (RT-PCR) or antigen test within 96 hours of baseline (those who have no history of confirmed COVID-19 within 3 months from the time of screening)

• Patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before screening, 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 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.

• 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

• Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of 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 investigational product

• Pregnant, breast-feeding or females with positive pregnancy test at screening

• Females and males who have a child-bearing plan or who are unwilling to commit to the use of the highly effective methods of contraception during the study period and for 3 months after the study period, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence and surgical sterilization (vasectomy, tubal ligation, etc.)

• Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons