The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

NCT04475107 | Completed Phase 2

• 1 other identifier: SP-PA-COV-201
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 13

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.

Conditions

COVID-19

Keywords

Pyramax; Pyronaridine; Artesunate; COVID-19; Corona virus

Outcome Measures

Primary Outcomes (1)

• Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*

  \* Patients who are rRT-PCR negative for COVID-19

  Day 7

Secondary Outcomes (7)

• Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline

  Day 3, 7, 10, 14

• Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*

  Day 3, 10, 14

• Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline

  Day 3, 7, 10, 14, 28

• Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline

  Day 3, 7, 10, 14, 28

• Time to achieve normalization of body temperature, post-dose

  Day 3, 7, 10, 14, 28

Study Arms (2)

Arm A

EXPERIMENTAL

Pyramax (Pyronaridine 180mg/ Artesunate 60mg)

Drug: Pyronaridine-Artesunate

Arm B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pyronaridine-Artesunate DRUG

Pyramax

Arm A

Placebo DRUG

Placebo

Arm B

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 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (13)

Korea University Ansan Hospital

Ansan, South Korea

Location

Chungnam national University Hospital

Daejeon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyungpook National University Hospital

Seoul, South Korea

Location

National Medical Center

Seoul, South Korea

Location

Sahmyook Medical Center

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Marys' Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, 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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: July 9, 2020
• Primary Completion: March 25, 2021
• Study Completion: April 15, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-04

Locations

KR (13)