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

NCT05633420 | Completed Phase 2

• 1 other identifier: SP-PA-COV-204
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

COVID-19

Keywords

Pyramax; pyronaridine-artesunate; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in SARS-CoV-2 infectious virus titer by viral culture

  follow up to Day14

• Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR

  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

  follow up to Day29

• Percentage of patients with new and aggravated pneumonia until 29 days after administration of the investigational product

  follow up to Day29

Other Outcomes (2)

• 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 of all COVID-19-related symptoms for ≥96 hours

  follow up to Day29

Study Arms (1)

Pyramax

EXPERIMENTAL

pyronaridine-artesunate (180/160 mg)

Drug: Pyramax

Interventions

Pyramax DRUG

Participant body weight * ≥65 kg (Pyramax 4 tablets) * ≥45 kg and \<65 kg (Pyramax 3 tablets)

Also known as: pyronaridine-artesunate

Pyramax

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (2)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

pyronaridine tetraphosphate, artesunate drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yee Gyung Kwak, MD, Phd

  Inje University Ilsan Paik Hospital

  PRINCIPAL INVESTIGATOR

• Jin Soo Lee, MD, Phd

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 1, 2022
• Study Start: July 24, 2022
• Primary Completion: September 6, 2022
• Study Completion: November 20, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)