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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pyramax
Sponsored by
Shin Poong Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Pyramax, pyronaridine-artesunate, COVID-19, SARS-CoV-2

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inje University Ilsan Paik Hospital
  • Inha University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyramax

Arm Description

pyronaridine-artesunate (180/160 mg)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in SARS-CoV-2 infectious virus titer by viral culture
Changes in COVID-19 infectious viral titer compared to the baseline
Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR
Changes in COVID-19 viral RNA load compared to the baseline
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
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

Full Information

First Posted
November 30, 2022
Last Updated
November 30, 2022
Sponsor
Shin Poong Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05633420
Brief Title
Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 24, 2022 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Poong Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Pyramax, pyronaridine-artesunate, COVID-19, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyramax
Arm Type
Experimental
Arm Description
pyronaridine-artesunate (180/160 mg)
Intervention Type
Drug
Intervention Name(s)
Pyramax
Other Intervention Name(s)
pyronaridine-artesunate
Intervention Description
Participant body weight ≥65 kg (Pyramax 4 tablets) ≥45 kg and <65 kg (Pyramax 3 tablets)
Primary Outcome Measure Information:
Title
Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product
Description
Time took for subjects with positive infectious viable virus from virus culture at the baseline to get first negative infectious virus test result
Time Frame
follow up to Day29
Secondary Outcome Measure Information:
Title
Change from baseline in SARS-CoV-2 infectious virus titer by viral culture
Description
Changes in COVID-19 infectious viral titer compared to the baseline
Time Frame
follow up to Day14
Title
Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR
Description
Changes in COVID-19 viral RNA load compared to the baseline
Time Frame
follow up to Day14
Title
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
Description
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
Time Frame
follow up to Day29
Title
Percentage of patients with new and aggravated pneumonia until 29 days after administration of the investigational product
Description
Defined as new occurrence or aggravation of existing pneumonia
Time Frame
follow up to Day29
Other Pre-specified Outcome Measures:
Title
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
Description
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]
Time Frame
follow up to Day29
Title
Time to sustained symptom resolution of all COVID-19-related symptoms for ≥96 hours
Description
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
Time Frame
follow up to Day29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yee Gyung Kwak, MD, Phd
Organizational Affiliation
Inje University Ilsan Paik Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Soo Lee, MD, Phd
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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