A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19 Infection

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.1 site in 1 country80 target enrollmentMarch 10, 2023

ConditionsCOVID-19 Infection

InterventionsWPV01 Placebo

DrugsWPV01 Placebo

Overview

Phase: Phase 2
Intervention: WPV01
Conditions: COVID-19 Infection
Sponsor: Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
Enrollment: 80
Locations: 1
Primary Endpoint: Changes in viral load
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19 infection

Registry

clinicaltrials.gov

Start Date

March 10, 2023

End Date

July 3, 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

•Participants ≥18 years of age when signing ICF;
•Initial onset at least 1 of 11 COVID-19 symptoms within 48 hours before randomization;
•Within three days before randomization, the RT-PCR test of specimens such as nasal and pharyngeal swabs must be positive for SARS-CoV-2 or the rapid antigen test must be positive, and also the patiets should meet the diagnostic criteria for mild or moderate cases as defined in the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10) issued by the National Health Commission of China;
•Fertile participants must agree to take effective contraceptive measures;
•Participants who understand and agree to comply with planned study procedures，voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria

•Known allergy to any ingredient in the study treatment drug;
•Patients who meet the diagnostic criteria for severe or critical cases of COVID-19 as defined in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10) issued by the National Health Commission of China at the time of randomization;
•Obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥1.5ULN);
•On dialysis or combined with moderate to severe kidney injury;
•Patients with compromised immune system;
•Patients with acute exacerbation of chronic respiratory disease at screening, including bronchial asthma, chronic obstructive pulmonary disease;
•Patients with suspected or confirmed concurrent active systemic infection other than COVID-19 at screening;
•Any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator;
•Has received or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment;
•Has received treatment with antivirals against SARS-CoV-2 within 14 days prior to randomization;

Arms & Interventions

WPV01

Intervention: WPV01

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Changes in viral load

Time Frame: Baseline through Day 7

Change of viral load compared to the baseline

Secondary Outcomes

Change in the score of each COVID-19 symptom(Baseline through Day 14)
Change in the total score of COVID-19 symptoms(Baseline through Day 14)
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)(Baseline through Day 14)
percentage of patients who reached the sustained clinical recovery of COVID-19 symptoms in every visit(Baseline through Day 14)
progression of COVID-19 infection(Baseline through Day 14)
Time to the first negative SARS CoV-2 test result(Baseline through Day 14)