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

NCT05752175 | Completed Phase 2

• 1 other identifier: WPV01-CP-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in viral load

  Change of viral load compared to the baseline

  Baseline through Day 7

Secondary Outcomes (6)

• Change in the total score of COVID-19 symptoms

  Baseline through Day 14

• Change in the score of each COVID-19 symptom

  Baseline through Day 14

• Change of EuroQol Questionnaire - 5 Dimension (EQ-5D)

  Baseline through Day 14

• percentage of patients who reached the sustained clinical recovery of COVID-19 symptoms in every visit

  Baseline through Day 14

• Time to the first negative SARS CoV-2 test result

  Baseline through Day 14

Study Arms (2)

WPV01

EXPERIMENTAL

Drug: WPV01

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

WPV01 DRUG

WPV01 tablets

WPV01

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Westlake Pharmaceuticals (Hangzhou) Co., Ltd.: lead

Study Sites (1)

Shulan(Hangzhou) Hospital

Hangzhou, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hainv Gao

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 2, 2023
• Study Start: March 10, 2023
• Primary Completion: May 9, 2023
• Study Completion: July 3, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CN (1)