COVID-19 InfectionPhase 2NCT05752175
Study of WPV01 Compared With Placebo in Patients With Mild/Moderate COVID-19 Infection
A Phase 2 study testing WPV01 in people with COVID-19 Infection, run by Westlake Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- WPV01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to 3 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- COVID-19 Infection
- Being tested
- WPV01, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WPV01Drug
WPV01 tablets
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| WPV01 | Experimental | Not described Receives: Drug: WPV01 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in viral load
Change of viral load compared to the baseline
Measured: Baseline through Day 7
Secondary outcomes (6)
Change in the total score of COVID-19 symptoms
Change in the total score of COVID-19 symptoms compared to the baseline
Measured: Baseline through Day 14
Change in the score of each COVID-19 symptom
Change in the score of each COVID-19 symptom compared to the baseline
Measured: Baseline through Day 14
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D) compared to the baseline
Measured: Baseline through Day 14
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
Measured: Baseline through Day 14
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
Measured: Baseline through Day 14
progression of COVID-19 infection
the percentage of patients who progressed to severe/critical COVID-19 or death from any cause
Measured: Baseline through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start10 Mar 2023
- Primary completion9 May 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hainv Gao, Principal investigator, Shulan (Hangzhou) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752175
- Sponsor's protocol ID
- WPV01-CP-02
- Status last verified
- Jun 2024
- First submitted
- 1 Mar 2023
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 6 months after summary data has been published, sponsor will share the IPD and additional supporting information after internal approval process.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05752175
- Acronym / sponsor ID
- WPV01-CP-02
- Conditions
- COVID-19 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Westlake Pharmaceuticals (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WPV01 | Experimental | Drug: WPV01 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WPV01WPV01 tablets | Drug | WPV01 |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
Changes in viral load
Time frame: Baseline through Day 7
Change of viral load compared to the baseline
6 secondary outcomes
Change in the total score of COVID-19 symptoms
Time frame: Baseline through Day 14
Change in the score of each COVID-19 symptom
Time frame: Baseline through Day 14
Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)
Time frame: 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
Time to the first negative SARS CoV-2 test result
Time frame: Baseline through Day 14
progression of COVID-19 infection
Time frame: Baseline through Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided. 6 months after summary data has been published, sponsor will share the IPD and additional supporting information after internal approval process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hainv Gao principal investigator
Shulan (Hangzhou) Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WPV01 in people with COVID-19 Infection, run by Westlake Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in viral load (time frame: Baseline through Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.