A Multi-center, Randomized, Double-blind, Parallel, Placebo-Controlled, Phase III Clinical Trial to Evaluate Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

Shin Poong Pharmaceutical Co. Ltd.66 sites in 4 countries1,807 target enrollmentOctober 18, 2021

ConditionsCOVID-19

InterventionsPyramax Placebo

DrugsPyramax Placebo

Overview

Phase: Phase 3
Intervention: Pyramax
Conditions: COVID-19
Sponsor: Shin Poong Pharmaceutical Co. Ltd.
Enrollment: 1807
Locations: 66
Primary Endpoint: Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
Status: Completed
Last Updated: 2 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 III clinical trial to evaluate efficacy and safety of pyramax in mild to moderate COVID-19 patients.

Registry

clinicaltrials.gov

Start Date

October 18, 2021

End Date

March 24, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shin Poong Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult males and females aged 19 years or older (or minimum age for adulthood or for informed consent below 19 years for each country)
•Patients with body weight ≥45 kg at screening
•Patients with COVID-19 confirmed by RT-PCR before randomization
•Patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days before randomization, who do not need adjunctive oxygen therapy
•Patients who are fully informed of this study, voluntarily decide to participate in this study and provide written consent to comply with requirements for this study

Exclusion Criteria

•Patients with severe or critical\* COVID-19
•Patients requiring hospitalization for therapeutic purposes for COVID-19 such as oxygen therapy with a decrease of oxygen saturation (\<94%) at screening or higher level of care, or who may be potentially transferred to another hospital other than the clinical trial institution within 72 hours.
•Patients who have received or who have planned to receive any anti-viral drugs to treat COVID-19 infection or medications that may affect the course of treatment within 28 days before participating in this study or before a sufficient wash-out period \[more than five times the half-life of the drug, etc.\] (the longer period between the two is chosen).
•Patients with one or more of the following infections in the past or present
•Infection with need for systemic anti-infection treatment other than Corona virus (SARS-CoV-2)
•Major infection with need for oral antibiotics or hospitalization within 30 days before administration of the investigational product by discretion of the investigator.
•Patients with a known clinically significant anemia (Hemoglobin \<8.0 g/dL)
•Patients with a known severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2)
•Patients with a known severe hepatic dysfunction
•Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of the investigational product

Arms & Interventions

Test

Pyramax tablet

Intervention: Pyramax

Control

Placebo tablet

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.

Time Frame: follow up to Day29

Secondary Outcomes

Percentage of subjects requiring acute therapy for more than 24 hours in a hospital or acute treatment facility or who have died due to COVID-19 until D29 after administration(follow up to Day29)
Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14(Day2, Day3, Day5, Day7, Day14)
Time to sustained recovery (discharge) in hospitalized subjects (days)(follow up to Day29)
NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline(Day3, Day7, Day14, Day21, Day29)
11-point WHO clinical progression scale for clinical symptoms at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline(Day3, Day7, Day14, Day21, Day29)
29-day mortality after the first dose of the investigational product(Day29)
Percentage of subjects who have newly diagnosed with pneumonia or aggravated pneumonia* according to baseline pneumonia criteria until D29 after administration of the IP(follow up to Day29)
Percentage of subjects in the high-risk group** who require hospitalization or have died due to COVID-19 until post-dose D29(follow up to Day29)