The 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
Pyronaridine-Artesunate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Pyramax, Pyronaridine, Artesunate, COVID-19, Corona virus
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
- Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.)
- 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.
- Pregnant or lactating women
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.)
- Participating in another clinical trial currently or within 28 days from signing the informed consent
- Patients that are deemed ineligible to participate in the clinical trial by the Investigator
Sites / Locations
- Korea University Ansan Hospital
- Chungnam national University Hospital
- Inha University Hospital
- Gangnam Severance Hospital
- Hallym University Kangnam Sacred Heart Hospital
- Korea University Guro Hospital
- Kyungpook National University Hospital
- National Medical Center
- Sahmyook Medical Center
- Seoul Medical Center
- Severance Hospital
- The Catholic University of Korea, Eunpyeong St. Marys' Hospital
- Ajou University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A
Arm B
Arm Description
Pyramax (Pyronaridine 180mg/ Artesunate 60mg)
Placebo
Outcomes
Primary Outcome Measures
Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
* Patients who are rRT-PCR negative for COVID-19
Secondary Outcome Measures
Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline
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
Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline
Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline
Time to achieve normalization of body temperature, post-dose
Time to achieve normalization of respiratory rate, post-dose
Time to achieve normalization of oxygen saturation, post-dose
Full Information
NCT ID
NCT04475107
First Posted
July 14, 2020
Last Updated
May 27, 2021
Sponsor
Shin Poong Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04475107
Brief Title
The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
April 15, 2021 (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
5. Study Description
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.
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, Corona virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Pyramax (Pyronaridine 180mg/ Artesunate 60mg)
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pyronaridine-Artesunate
Intervention Description
Pyramax
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
Description
* Patients who are rRT-PCR negative for COVID-19
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline
Time Frame
Day 3, 7, 10, 14
Title
Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*
Description
* Patients who are rRT-PCR negative for COVID-19
Time Frame
Day 3, 10, 14
Title
Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline
Time Frame
Day 3, 7, 10, 14, 28
Title
Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline
Time Frame
Day 3, 7, 10, 14, 28
Title
Time to achieve normalization of body temperature, post-dose
Time Frame
Day 3, 7, 10, 14, 28
Title
Time to achieve normalization of respiratory rate, post-dose
Time Frame
Day 3, 7, 10, 14, 28
Title
Time to achieve normalization of oxygen saturation, post-dose
Time Frame
Day 3, 7, 10, 14, 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.)
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.
Pregnant or lactating women
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.)
Participating in another clinical trial currently or within 28 days from signing the informed consent
Patients that are deemed ineligible to participate in the clinical trial by the Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Chungnam national University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
National Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Sahmyook Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Eunpyeong St. Marys' Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients
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