Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product [follow up to Day29]
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 [follow up to Day14]
Changes in COVID-19 infectious viral titer compared to the baseline
- Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR [follow up to Day14]
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 [follow up to Day29]
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 [follow up to Day29]
Defined as new occurrence or aggravation of existing pneumonia
Other Outcome Measures
- 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 [follow up to Day29]
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 to sustained symptom resolution of all COVID-19-related symptoms for ≥96 hours [follow up to Day29]
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
Eligibility Criteria
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
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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:
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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.
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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
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Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of investigational product
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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)
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Patients who cannot be orally administered investigational product
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Pregnant, breast-feeding or females with positive pregnancy test at screening
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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.)
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Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | Korea, Republic of | 10380 |
| 2 | Inha University Hospital | Incheon | Korea, Republic of | 22332 |
Sponsors and Collaborators
- Shin Poong Pharmaceutical Co. Ltd.
Investigators
- Principal Investigator: Yee Gyung Kwak, MD, Phd, Inje University Ilsan Paik Hospital
- Principal Investigator: Jin Soo Lee, MD, Phd, Inha University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP-PA-COV-204