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Study of WPV01 Compared With Placebo in Patients With Mild/Moderate COVID-19 Infection

Primary Purpose

COVID-19 Infection

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
WPV01
Placebo
Sponsored by
Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; Has received any novel coronavirus infection vaccine within 1 week prior to randomization; Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance; Difficulty swallowing or a history of gastrointestinal disorders that severely interfere with drug absorption; BMI≥30 kg/m2; Pregnant, lactating women or those with a positive pregnancy test; Previous administration with any investigational drug within 3 months before the study drug administration; Patients who are judged by the investigator to be unsuitable to participate in this study.

Sites / Locations

  • Shulan(Hangzhou) HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

WPV01

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in viral load
Change of viral load compared to the baseline

Secondary Outcome Measures

Change in the total score of COVID-19 symptoms
Change in the total score of COVID-19 symptoms compared to the baseline
Change in the score of each COVID-19 symptom
Change in the score of each COVID-19 symptom compared to the baseline
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D) compared to the baseline
percentage of patients who reached the sustained clinical recovery of COVID-19 symptoms in every visit
percentage of patients who reached COVID-19 symptoms scores of 0 for two consecutive days in every visit
Time to the first negative SARS CoV-2 test result
The time from the start of treatment to the time when the first negative SARS CoV-2 qPCR result showed CT value ≥35
progression of COVID-19 infection
the percentage of patients who progressed to severe/critical COVID-19 or death from any cause

Full Information

First Posted
March 1, 2023
Last Updated
April 3, 2023
Sponsor
Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05752175
Brief Title
Study of WPV01 Compared With Placebo in Patients With Mild/Moderate COVID-19 Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Westlake Pharmaceuticals (Hangzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WPV01
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
WPV01
Intervention Description
WPV01 tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Changes in viral load
Description
Change of viral load compared to the baseline
Time Frame
Baseline through Day 7
Secondary Outcome Measure Information:
Title
Change in the total score of COVID-19 symptoms
Description
Change in the total score of COVID-19 symptoms compared to the baseline
Time Frame
Baseline through Day 14
Title
Change in the score of each COVID-19 symptom
Description
Change in the score of each COVID-19 symptom compared to the baseline
Time Frame
Baseline through Day 14
Title
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)
Description
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D) compared to the baseline
Time Frame
Baseline through Day 14
Title
percentage of patients who reached the sustained clinical recovery of COVID-19 symptoms in every visit
Description
percentage of patients who reached COVID-19 symptoms scores of 0 for two consecutive days in every visit
Time Frame
Baseline through Day 14
Title
Time to the first negative SARS CoV-2 test result
Description
The time from the start of treatment to the time when the first negative SARS CoV-2 qPCR result showed CT value ≥35
Time Frame
Baseline through Day 14
Title
progression of COVID-19 infection
Description
the percentage of patients who progressed to severe/critical COVID-19 or death from any cause
Time Frame
Baseline through Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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; Has received any novel coronavirus infection vaccine within 1 week prior to randomization; Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance; Difficulty swallowing or a history of gastrointestinal disorders that severely interfere with drug absorption; BMI≥30 kg/m2; Pregnant, lactating women or those with a positive pregnancy test; Previous administration with any investigational drug within 3 months before the study drug administration; Patients who are judged by the investigator to be unsuitable to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongdong Liang
Phone
86057186806939
Email
liangdongdong@westlake-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hainv Gao
Organizational Affiliation
Shulan (Hangzhou) Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shulan(Hangzhou) Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hainv Gao

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
6 months after summary data has been published, sponsor will share the IPD and additional supporting information after internal approval process.

Learn more about this trial

Study of WPV01 Compared With Placebo in Patients With Mild/Moderate COVID-19 Infection

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