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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475107
• Other study ID #: SP-PA-COV-201
• Status: Completed
• Phase: Phase 2
• Start date: July 9, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2021
• Source: Shin Poong Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: April 15, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Pyronaridine-Artesunate
Pyramax
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Chungnam national University Hospital	Daejeon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyungpook National University Hospital	Seoul
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Sahmyook Medical Center	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Marys' Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Shin Poong Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*	* Patients who are rRT-PCR negative for COVID-19	Day 3, 10, 14
Secondary	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
Secondary	Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline		Day 3, 7, 10, 14, 28
Secondary	Time to achieve normalization of body temperature, post-dose		Day 3, 7, 10, 14, 28
Secondary	Time to achieve normalization of respiratory rate, post-dose		Day 3, 7, 10, 14, 28
Secondary	Time to achieve normalization of oxygen saturation, post-dose		Day 3, 7, 10, 14, 28