Phase III Clinical Study Evaluating the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19

Westlake Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Mild to Moderate COVID-19

Treatments

Drug: WPV01

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06197217

WPV01-CP-23

Details and patient eligibility

About

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.

Enrollment

1,350 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
1. 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
2. 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.