A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of WPV01 in Patients With Mild to Moderate COVID-19

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.1 site in 1 country1,350 target enrollmentJune 14, 2023

ConditionsMild to Moderate COVID-19

InterventionsWPV01 Placebo

DrugsWPV01 Placebo

Overview

Phase: Phase 3
Intervention: WPV01
Conditions: Mild to Moderate COVID-19
Sponsor: Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
Enrollment: 1350
Locations: 1
Primary Endpoint: Time from first dose to sustained clinical recovery of 11 COVID-19 symptoms within 28 days
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a multicenter, randomized, double-blind, placebo-controlled efficacy, safety Phase III clinical trial designed to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19.

Registry

clinicaltrials.gov

Start Date

June 14, 2023

End Date

September 20, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients ≥18 years at the time of signing informed consent, those with a history of COVID-19 were also eligible for enrollment in this study
•Meet the diagnostic criteria for mild or moderate COVID-19 infection according to the the Diagnostic and Treatment Program for COVID-19 Infections (Trial Tenth Edition) issued by the China Health and Wellness Commission:
•Positive for SARS-CoV-2 nucleic acid or positive for SARS-CoV-2 antigen in a nasopharyngeal swab specimen within 72 hours prior to randomization
•The onset of a COVID-19-related target symptom is less than 72 hours from randomization and the presence of at least 1 of the 5 key COVID-19-related symptoms with a severity of ≥2 points on the day of randomization
•Females of childbearing potential (details are defined in Appendix 3) Subjects must have a negative pregnancy test at Screening. Subjects will be required to use effective contraception throughout the study period beginning with the signing of the informed consent form and for 30 days after completion of the study.
•Eligible to understand the procedures and methods of this clinical trial, with full informed consent and voluntary participation by the subjects.

Exclusion Criteria

•Known allergy to any of the ingredients in the investigational therapeutic agents
•Meet the diagnostic criteria for severe or critical COVID-19 infection according to the Diagnostic and Treatment Program for COVID-19 Infections (Trial Tenth Edition) issued by the China Health and Wellness Commission at the time of randomization.
•Within 14 days prior to randomization, the subject has received SARS-CoV-2 antiviral therapy or immunotherapy including, but not limited to, antiviral medications (e.g., interferon, raltegravir, lopinavir/ritonavir, favipiravir, ribavirin, chloroquine phosphate, arbidol, nirmatrelvir/ritonavir, molnupiravir, azulfidine, simnotrelvir/ritonavir, deuremidevir, and COVID-19 therapeutics approved during subsequent studies), corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulins
•Within 3 days or 5 drug half-lives (whichever is longer) prior to randomization, the subject has used medications to alleviate symptoms of COVID-19: including, but not limited to, antipyretic/analgesic, cough suppressant/expectorant, compounded cold and flu remedies, antihistamines, anti-bacterials and anti-fungals
•Abnormal liver function at screening: total bilirubin ≥ 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN
•Being on dialysis or having a combination of moderate to severe renal insufficiency
•Immunocompromised at screening (including patients with malignant tumors, organ or bone marrow transplantation, or treatment with corticosteroids or other immunosuppressive agents)
•Chronic respiratory disease, including bronchial asthma, chronic obstructive pulmonary disease, at the time of screening
•Suspected or confirmed acute systemic infections other than COVID-19 at the time of screening
•Any comorbidity requiring surgery within 14 days prior to randomization, or any comorbidity considered life-threatening by the investigator within 30 days prior to randomization

Arms & Interventions

WPV01

Intervention: WPV01

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Time from first dose to sustained clinical recovery of 11 COVID-19 symptoms within 28 days

Time Frame: Day 1 to Day 28

Secondary Outcomes

Proportion of subjects requiring supplemental oxygen within 28 days(Day 1 to Day 28)
Time from first dose to sustained clinical recovery of 5 key COVID-19 related symptoms within 28 days(Day 1 to Day 28)
Decrease in viral load from baseline on Day 5 of treatment(Day 1 to Day 28)
Time to sustained clinical remission of 11 COVID-19 symptoms within 28 days of treatment(Day 1 to Day 28)
Changes in 11 COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28(Day 1 to Day 28)
Time to sustained clinical remission of 5 key COVID-19 related symptoms within 28 days(Day 1 to Day 28)
Changes in 5 key COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28(Day 1 to Day 28)
Percentage of subjects with SARS-CoV-2 RNA below the threshold on Day 3, 5, 7, 9 and 14(Day 1 to Day 14)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Day 28)
Percentage of subjects achieving sustained clinical recovery of 11 COVID-19 symptoms at Day 5, 9, 14, 21, and 28(Day 1 to Day 28)
Percentage of subjects achieving sustained clinical remission of 11 COVID-19 symptoms on Day 5, 9, 14, 21, and 28(Day 1 to Day 28)
Percentage of subjects achieving sustained clinical recovery of 5 key COVID-19 related symptoms at Day 5, 9, 14, 21, and 28(Day 1 to Day 28)
Percentage of subjects who experienced COVID-19 progression within 28 days(Day 1 to Day 28)
Change in World Health Organization (WHO) Clinical Progress Scale Score within 28 days(Day 1 to Day 28)
Time from first dose to SARS-CoV-2 RNA below the threshold after treatment within 14 days(Day 1 to Day 14)
Change from baseline in viral load at each visit from treatment to Day 14(Day 1 to Day 14)