Clinical trial NCT04475107: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Pyramax
Pyronaridine
Artesunate
COVID-19
Corona virus
Lead sponsor: Shin Poong Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 113
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥19 years at the time of signing Informed Consent Form
2. Body weight ≥45 kg at screening
3. 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
4. Oxygen saturation(SpO2) \> 94% at randomization, in room air condition
5. Willing and able to provide informed consent

Exclusion Criteria:

1. Diagnosed with severe pneumonia
2. Patients with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation)
3. Patients with clinically significant anemia (Hemoglobin \<8.0 g/dL)
4. Patient with known allergic reaction or contraindication to any of the investigational medicinal product (pyronaridine tetraphosphate, artesunate)
5. Patients with known history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
6. 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)
7. 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)
8. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
9. 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)
10. Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of other antiviral agents
11. Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.)
12. 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.
13. Pregnant or lactating women
14. 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.)
15. Participating in another clinical trial currently or within 28 days from signing the informed consent
16. Patients that are deemed ineligible to participate in the clinical trial by the Investigator

Primary outcomes:
measure: Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
timeFrame: Day 7
Secondary outcomes:
measure: Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline
timeFrame: Day 3, 7, 10, 14
measure: Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*
timeFrame: Day 3, 10, 14
measure: Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline
timeFrame: Day 3, 7, 10, 14, 28
measure: Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline
timeFrame: Day 3, 7, 10, 14, 28
measure: Time to achieve normalization of body temperature, post-dose
timeFrame: Day 3, 7, 10, 14, 28
measure: Time to achieve normalization of respiratory rate, post-dose
timeFrame: Day 3, 7, 10, 14, 28
measure: Time to achieve normalization of oxygen saturation, post-dose
timeFrame: Day 3, 7, 10, 14, 28
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam national University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Sahmyook Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Marys' Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References: