Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

A Multi-Center Single Arm, Open-label, Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

This study is a multi-center, single-arm, open-label, pilot clinical trial to explore efficacy and safety of Pyramax in mild to moderate COVID-19 patients

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Pyramax

Detailed Description

This study is a multi-center, single-arm, open-label, pilot clinical trial to explore the efficacy and safety of Pyramax Tab. in patients diagnosed with mild to moderate Coronavirus Disease-19 (COVID-19).

Major inclusion criteria are eligible patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before the screening, who do not need adjunctive oxygen therapy.

Subjects eligible to participate in this study will be enrolled and will take Investigational Product once a day for 3 days.

Subjects will participate in this study for 29 days in total, and subjects will follow the procedure in accordance with the Schedule of Clinical Trial Events to evaluate efficacy and safety after administration of Investigational Product.

Even though subjects are released from quarantine or discharged after showing clinical improvements, subjects should continue to visit hospitals for follow-up until 29 days in accordance with scheduled visit. The criteria of specific discharge (release from quarantine) for confirmed COVID-19 patients with symptoms should follow the latest version of the infectious disease prevention and control guideline.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
      • Inje University Ilsan Paik 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:

• Age 19 years or older
• Patients with body weight ≥45 kg at screening
• Patients who were first confirmed with COVID-19 through Real-Time Polymerase Chain Reaction (RT-PCR) or antigen test within 96 hours of baseline (those who have no history of confirmed COVID-19 within 3 months from the time of screening)
• Patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before screening, 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 or higher level of care, or who may be potentially transferred to another hospital other than the institution within 72 hours, with decreased oxygen saturation (<94%) at screening.
• Patients who have received or who have plans 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
• Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of investigational product
• Patients with a gastrointestinal disease or who underwent a surgery that can affect the absorption, distribution, metabolism and excretion of the drug, or who have active gastritis, gastrointestinal tract/rectal bleeding, gastric ulcer, and pancreatitis or pancreatic function abnormalities (excluding general appendectomy or hernia repair surgery)
• Patients who cannot be orally administered investigational product
• Pregnant, breast-feeding or females with positive pregnancy test at screening
• Females and males who have a child-bearing plan or who are unwilling to commit to the use of the highly effective methods of contraception during the study period and for 3 months after the study period, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence and surgical sterilization (vasectomy, tubal ligation, etc.)
• Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pyramax; pyronaridine-artesunate (180/160 mg)	Drug: Pyramax; Participant body weight; ≥65 kg (Pyramax 4 tablets); ≥45 kg and <65 kg (Pyramax 3 tablets); Other Names: pyronaridine-artesunate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product	Time took for subjects with positive infectious viable virus from virus culture at the baseline to get first negative infectious virus test result	follow up to Day29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in SARS-CoV-2 infectious virus titer by viral culture	Changes in COVID-19 infectious viral titer compared to the baseline	follow up to Day14
Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR	Changes in COVID-19 viral RNA load compared to the baseline	follow up to Day14
Percentage of subjects requiring acute treatment for more than 24 hours in a hospital or acute treatment facility due to COVID-19 or who have died until 29 days after administration	Proportion of participants with progression to severe COVID-19 through Day 29 assessed by the composite outcome of COVID-19-related adjudicated hospitalization or oxygen therapy or more extensive care or death from any cause	follow up to Day29
Percentage of patients with new and aggravated pneumonia until 29 days after administration of the investigational product	Defined as new occurrence or aggravation of existing pneumonia	follow up to Day29

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to sustained symptom resolution (score of 0 to 1) on 11-point World Health Organization Clinical Progression Scale after administration of the investigational product	Time to sustained symptom resolution [defined as the instance of the first asymptomatic status (score of 0 to 1) for ≥96 hours on the 11-point World Health Organization Clinical Progression Scale for clinical symptoms]	follow up to Day29
Time to sustained symptom resolution of all COVID-19-related symptoms for ≥96 hours	Defined symptoms include congestion or runny nose, sore throat, cough, fever, fatigue, shortness of breath or difficulty breathing, chills, muscle or body aches, headache, nausea, vomiting, diarrhea, loss of smell, loss of taste and other symptoms associated with COVID-19	follow up to Day29

Collaborators and Investigators

• Sponsor: Shin Poong Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Yee Gyung Kwak, MD, Phd, Inje University Ilsan Paik Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2022
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): November 20, 2022

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Pyramax; pyronaridine-artesunate
• 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-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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