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

June 11, 2024 updated by: Westlake Pharmaceuticals (Hangzhou) Co., Ltd.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Hangzhou, China
        • Shulan(Hangzhou) Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants ≥18 years of age when signing ICF;
  2. Initial onset at least 1 of 11 COVID-19 symptoms within 48 hours before randomization;
  3. 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;
  4. Fertile participants must agree to take effective contraceptive measures;
  5. 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:

  1. Known allergy to any ingredient in the study treatment drug;
  2. 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;
  3. Obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥1.5ULN);
  4. On dialysis or combined with moderate to severe kidney injury;
  5. Patients with compromised immune system;
  6. Patients with acute exacerbation of chronic respiratory disease at screening, including bronchial asthma, chronic obstructive pulmonary disease;
  7. Patients with suspected or confirmed concurrent active systemic infection other than COVID-19 at screening;
  8. 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;
  9. Has received or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment;
  10. Has received treatment with antivirals against SARS-CoV-2 within 14 days prior to randomization;
  11. Has received any novel coronavirus infection vaccine within 1 week prior to randomization;
  12. Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance;
  13. Difficulty swallowing or a history of gastrointestinal disorders that severely interfere with drug absorption;
  14. BMI≥30 kg/m2;
  15. Pregnant, lactating women or those with a positive pregnancy test;
  16. Previous administration with any investigational drug within 3 months before the study drug administration;
  17. Patients who are judged by the investigator to be unsuitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablets
Experimental: WPV01
Drug: WPV01
WPV01 tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in viral load
Time Frame: Baseline through Day 7
Change of viral load compared to the baseline
Baseline through Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the total score of COVID-19 symptoms
Time Frame: Baseline through Day 14
Change in the total score of COVID-19 symptoms compared to the baseline
Baseline through Day 14
Change in the score of each COVID-19 symptom
Time Frame: Baseline through Day 14
Change in the score of each COVID-19 symptom compared to the baseline
Baseline through Day 14
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)
Time Frame: Baseline through Day 14
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D) compared to the baseline
Baseline through Day 14
percentage of patients who reached the sustained clinical recovery of COVID-19 symptoms in every visit
Time Frame: Baseline through Day 14
percentage of patients who reached COVID-19 symptoms scores of 0 for two consecutive days in every visit
Baseline through Day 14
Time to the first negative SARS CoV-2 test result
Time Frame: Baseline through Day 14
The time from the start of treatment to the time when the first negative SARS CoV-2 qPCR result showed CT value ≥35
Baseline through Day 14
progression of COVID-19 infection
Time Frame: Baseline through Day 14
the percentage of patients who progressed to severe/critical COVID-19 or death from any cause
Baseline through Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Westlake Pharmaceuticals (Hangzhou) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hainv Gao, Shulan (Hangzhou) Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WPV01-CP-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

6 months after summary data has been published, sponsor will share the IPD and additional supporting information after internal approval process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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