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

Shin Poong Pharmaceutical Co. Ltd.13 sites in 1 country113 target enrollmentJuly 9, 2020

ConditionsCOVID-19

InterventionsPyronaridine-Artesunate Placebo

DrugsPyronaridine-Artesunate Placebo

Overview

Phase: Phase 2
Intervention: Pyronaridine-Artesunate
Conditions: COVID-19
Sponsor: Shin Poong Pharmaceutical Co. Ltd.
Enrollment: 113
Locations: 13
Primary Endpoint: Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 9, 2020

End Date

April 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shin Poong Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥19 years at the time of signing Informed Consent Form
•Body weight ≥45 kg at screening
•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
•Oxygen saturation(SpO2) \> 94% at randomization, in room air condition
•Willing and able to provide informed consent

Exclusion Criteria

•Diagnosed with severe pneumonia
•Patients with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation)
•Patients with clinically significant anemia (Hemoglobin \<8.0 g/dL)
•Patient with known allergic reaction or contraindication to any of the investigational medicinal product (pyronaridine tetraphosphate, artesunate)
•Patients with known history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
•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)
•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)
•Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
•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)
•Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of other antiviral agents

Arms & Interventions

Arm A

Pyramax (Pyronaridine 180mg/ Artesunate 60mg)

Intervention: Pyronaridine-Artesunate

Arm B

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*

Time Frame: Day 7

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

Secondary Outcomes

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 oxygen saturation, post-dose(Day 3, 7, 10, 14, 28)
Time to achieve normalization of body temperature, post-dose(Day 3, 7, 10, 14, 28)
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*(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)
Time to achieve normalization of respiratory rate, post-dose(Day 3, 7, 10, 14, 28)