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

NCT ID: NCT04475107

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2021-04-15

Brief Summary

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm A

Pyramax (Pyronaridine 180mg/ Artesunate 60mg)

Group Type: EXPERIMENTAL

Pyronaridine-Artesunate

Intervention Type: DRUG

Pyramax

Arm B

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Pyronaridine-Artesunate

Pyramax

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Poong Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University Ansan Hospital

Ansan, , South Korea

Chungnam national University Hospital

Daejeon, , South Korea

Inha University Hospital

Incheon, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Kyungpook National University Hospital

Seoul, , South Korea

National Medical Center

Seoul, , South Korea

Sahmyook Medical Center

Seoul, , South Korea

Seoul Medical Center

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

The Catholic University of Korea, Eunpyeong St. Marys' Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

SP-PA-COV-201

Identifier Type: -

Identifier Source: org_study_id