- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197217
Phase III Clinical Study Evaluating the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19
January 9, 2024 updated by: Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1350
Phase
- Phase 3
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
- Name: Dongdong Liang
- Phone Number: +86-0571-86306939
- Email: liangdongdong@westlake-pharma.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100029
- Recruiting
- China Japan Friendship Hospital
-
Contact:
- Bin Cao
- Phone Number: +86-0571-86806939
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
- Patients who have received (within 30 days prior to randomization or within 5 drug half-lives, whichever is longer) or are expected to receive plasma therapy with SARS-CoV-2 monoclonal antibody or recovered COVID-19 during the study period
- Patients who have received any COVID-19 vaccine within 1 month prior to randomization
- Currently using or within 4 days post dose expected to use any drug or substance which are highly dependent on clearance via CYP3A4, MDR1, OAT1, or OAT3; used within 28 days prior to randomization or expected to use during the treatment drus with strong MDR1 inducer
- Patients who have difficulty in swallowing or history of gastrointestinal disorders that significantly affect the absorption of drugs
- Pregnant, lactating women
- Participated in other interventional clinical trials or use of experimental drugs within 1 month prior to administration;
- 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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Subjects in the Placebo group will receive WPV01 Placebo orally (3 tablets per dose), 3 times daily (TID) for 15 consecutive treatments
|
Experimental: WPV01
|
Subjects in the WPV01 group will receive WPV01 600mg orally (200mg, 3 tablets per dose), 3 times daily (TID) for 15 consecutive treatments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time from first dose to sustained clinical recovery of 11 COVID-19 symptoms within 28 days
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in viral load from baseline on Day 5 of treatment
Time Frame: Day 1 to Day 28
|
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
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Time to sustained clinical remission of 11 COVID-19 symptoms within 28 days of treatment
Time Frame: Day 1 to Day 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
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Changes in 11 COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Time from first dose to sustained clinical recovery of 5 key COVID-19 related symptoms within 28 days
Time Frame: Day 1 to Day 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
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Time to sustained clinical remission of 5 key COVID-19 related symptoms within 28 days
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Changes in 5 key COVID-19-related symptom scores from baseline to Day 5, 9, 14, 21, and 28
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Percentage of subjects who experienced COVID-19 progression within 28 days
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Proportion of subjects requiring supplemental oxygen within 28 days
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Change in World Health Organization (WHO) Clinical Progress Scale Score within 28 days
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Time from first dose to SARS-CoV-2 RNA below the threshold after treatment within 14 days
Time Frame: Day 1 to Day 14
|
Day 1 to Day 14
|
Percentage of subjects with SARS-CoV-2 RNA below the threshold on Day 3, 5, 7, 9 and 14
Time Frame: Day 1 to Day 14
|
Day 1 to Day 14
|
Change from baseline in viral load at each visit from treatment to Day 14
Time Frame: Day 1 to Day 14
|
Day 1 to Day 14
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 to Day 28
|
Day 1 to Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 14, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
January 8, 2024
First Submitted That Met QC Criteria
January 8, 2024
First Posted (Actual)
January 9, 2024
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 9, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WPV01-CP-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
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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