Clinical trial NCT05633420: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Pyramax
pyronaridine-artesunate
COVID-19
SARS-CoV-2
Lead sponsor: Shin Poong Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product
timeFrame: follow up to Day29
Secondary outcomes:
measure: Change from baseline in SARS-CoV-2 infectious virus titer by viral culture
timeFrame: follow up to Day14
measure: Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR
timeFrame: follow up to Day14
measure: 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
timeFrame: follow up to Day29
measure: Percentage of patients with new and aggravated pneumonia until 29 days after administration of the investigational product
timeFrame: follow up to Day29
Other outcomes:
measure: 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
timeFrame: follow up to Day29
measure: Time to sustained symptom resolution of all COVID-19-related symptoms for ≥96 hours
timeFrame: follow up to Day29
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inje University Ilsan Paik Hospital
name: Yee Gyung Kwak, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Jin Soo Lee, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: