This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase Ⅱ clinical trial to evaluate efficacy and safety of Pyramax in mild to moderate COVID-19 patients.
Drug: Pyronaridine-Artesunate
Pyramax
Drug: Placebo
Placebo
Inclusion Criteria:
1. Age ≥19 years at the time of signing Informed Consent Form
2. Body weight ≥45 kg at screening
3. Laboratory (rRT-PCR) confirmed infection with SARS-CoV-2 by testing specimens from
upper airway (i.e. nasopharyngeal and oropharyngeal swab) or lower airway (i.e.
sputum) within 96 hours of randomization
4. Oxygen saturation(SpO2) > 94% at randomization, in room air condition
5. Willing and able to provide informed consent
Exclusion Criteria:
1. Diagnosed with severe pneumonia
2. Patients with clinically significant cardiovascular disease (including arrhythmia, QTc
interval prolongation)
3. Patients with clinically significant anemia (Hemoglobin <8.0 g/dL)
4. Patient with known allergic reaction or contraindication to any of the investigational
medicinal product (pyronaridine tetraphosphate, artesunate)
5. Patients with known history of galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption, etc.
6. Patients with the gastrointestinal disease and surgery to affect the absorption,
distribution, metabolism and excretion of the drug, active gastritis, gastrointestinal
tract / rectal bleeding, gastric ulcer, pancreatitis abnormalities (except simple
appendectomy or hernia surgery)
7. Patients who received antiviral drugs that is intended to treat COVID-19, within 28
days prior to screening evaluation (can be enrolled into the study, if the patient has
gone through a sufficient wash-out period)
8. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30
mL/min/1.73 m2)
9. Patients with known severe liver disease (i.e. ALT or AST>5 times upper limit, nausea,
abdominal pain associated with jaundice or Child-Pugh stage B or C)
10. Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of
other antiviral agents
11. Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive
mechanical ventilation, extracorporeal membrane oxygenation, etc.)
12. Patients with chronic underlying disease (e.g. uncontrolled diabetes mellitus, chronic
kidney disease, chronic liver disease, chronic pulmonary disease, chronic
cardiovascular disease, blood cancer, cancer patients with cancer treatment, patients
taking immunosuppressants), highly obese patients, dialysis patients, and transplant
patients that are determined by the Physician, to be not suitable for trial
involvement.
13. Pregnant or lactating women
14. Male or female of childbearing potential who has plans to become pregnant during the
study period and for three months after the clinical study or who is not willing to
take appropriate contraceptive measures
*Hormonal contraception (contraceptive implant, injections, pills, etc.), IUDs,
condoms (male) and contraceptive diaphragm or cap (female), sterilization (vasectomy,
tubal ligation, etc.)
15. Participating in another clinical trial currently or within 28 days from signing the
informed consent
16. Patients that are deemed ineligible to participate in the clinical trial by the
Investigator
Korea University Ansan Hospital
Ansan, Korea, Republic of
Chungnam national University Hospital
Daejeon, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyungpook National University Hospital
Seoul, Korea, Republic of
National Medical Center
Seoul, Korea, Republic of
Sahmyook Medical Center
Seoul, Korea, Republic of
Seoul Medical Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Marys' Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of