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

NCT ID: NCT05752175

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2023-07-03

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

Conditions

COVID-19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

WPV01

Group Type: EXPERIMENTAL

WPV01

Intervention Type: DRUG

WPV01 tablets

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets

Interventions

WPV01

WPV01 tablets

Intervention Type: DRUG

Placebo

Placebo tablets

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hainv Gao

Role: PRINCIPAL_INVESTIGATOR

Shulan (Hangzhou) Hospital

Locations

Shulan(Hangzhou) Hospital

Hangzhou, , China

Countries

China

Other Identifiers

WPV01-CP-02

Identifier Type: -

Identifier Source: org_study_id