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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: Pyronaridine-Artesunate

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Korea University Ansan Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • National Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Seoul Medical Center
  • Seoul, Korea, Republic of
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Sahmyook medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Eunpyeong St. Marys' Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*	* Patients who are rRT-PCR negative for COVID-19	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*	* Patients who are rRT-PCR negative for COVID-19	Day 3, 10, 14
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
Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline		Day 3, 7, 10, 14, 28
Time to achieve normalization of body temperature, post-dose		Day 3, 7, 10, 14, 28
Time to achieve normalization of respiratory rate, post-dose		Day 3, 7, 10, 14, 28
Time to achieve normalization of oxygen saturation, post-dose		Day 3, 7, 10, 14, 28

Collaborators and Investigators

• Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Artesunate; Pyramax; Corona virus; Pyronaridine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anthelmintics; Schistosomicides; Antiplatyhelmintic Agents; Artesunate; Pyronaridine
• Other Study ID Numbers: SP-PA-COV-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No