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

• Sponsor: Shin Poong Pharmaceutical Co. Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04475107
• Collaborator: (none)
• Enrollment: 113
• Locations: 13
• Arms: 2
• Actual Duration (Months): 9.2
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Pyronaridine-Artesunate; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jul 9, 2020
• Actual Primary Completion Date: Mar 25, 2021
• Actual Study Completion Date: Apr 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Pyramax (Pyronaridine 180mg/ Artesunate 60mg)	Drug: Pyronaridine-Artesunate; Pyramax
Placebo Comparator: Arm B Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose* [Day 7]

   * Patients who are rRT-PCR negative for COVID-19

Secondary Outcome Measures

1. Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline [Day 3, 7, 10, 14]

2. Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose* [Day 3, 10, 14]

   * Patients who are rRT-PCR negative for COVID-19

3. Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline [Day 3, 7, 10, 14, 28]

4. Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline [Day 3, 7, 10, 14, 28]

5. Time to achieve normalization of body temperature, post-dose [Day 3, 7, 10, 14, 28]

6. Time to achieve normalization of respiratory rate, post-dose [Day 3, 7, 10, 14, 28]

7. Time to achieve normalization of oxygen saturation, post-dose [Day 3, 7, 10, 14, 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

1. Participating in another clinical trial currently or within 28 days from signing the informed consent

2. Patients that are deemed ineligible to participate in the clinical trial by the Investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Ansan Hospital	Ansan		Korea, Republic of
2	Chungnam national University Hospital	Daejeon		Korea, Republic of
3	Inha University Hospital	Incheon		Korea, Republic of
4	Gangnam Severance Hospital	Seoul		Korea, Republic of
5	Hallym University Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of
6	Korea University Guro Hospital	Seoul		Korea, Republic of
7	Kyungpook National University Hospital	Seoul		Korea, Republic of
8	National Medical Center	Seoul		Korea, Republic of
9	Sahmyook Medical Center	Seoul		Korea, Republic of
10	Seoul Medical Center	Seoul		Korea, Republic of
11	Severance Hospital	Seoul		Korea, Republic of
12	The Catholic University of Korea, Eunpyeong St. Marys' Hospital	Seoul		Korea, Republic of
13	Ajou University Hospital	Suwon		Korea, Republic of

Sponsors and Collaborators

• Shin Poong Pharmaceutical Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shin Poong Pharmaceutical Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04475107
• Other Study ID Numbers: SP-PA-COV-201
• First Posted: Jul 17, 2020
• Last Update Posted: Jun 1, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shin Poong Pharmaceutical Co. Ltd.: Pyramax; Pyronaridine; Artesunate; COVID-19; Corona virus
• Additional relevant MeSH terms: COVID-19; Artesunate; Pyronaridine

Study Results

No Results Posted as of Jun 1, 2021