A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHEN26 Capsule in Adult Participants With Mild to Moderate COVID-19

Shenzhen Kexing Pharmaceutical Co., Ltd.1 site in 1 country1,200 target enrollmentMay 13, 2023

ConditionsCOVID-19

InterventionsSHEN26 capsule SHEN26 placebo

DrugsSHEN26 capsule SHEN26 placebo

Overview

Phase: Phase 3
Intervention: SHEN26 capsule
Conditions: COVID-19
Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.
Enrollment: 1200
Locations: 1
Primary Endpoint: Time to 11 COVID-19 Symptom Resolution by Day 28
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19

Registry

clinicaltrials.gov

Start Date

May 13, 2023

End Date

July 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shenzhen Kexing Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants ≥18 years of age, male or female.
•The subjects were classified as mild or moderate COVID-19, confirmed SARS-CoV-2 infection 72 hours prior to randomization.
•Initial onset 2 of 11 COVID-19 symptoms within 72 hours before randomization, respiratory and feverish symptoms must be included.
•Female subjects of childbearing age must have a negative urine pregnancy test during the screening.Fertile participants must agree to take effective contraceptive measures.
•Understand the procedures and methods of this clinical trial, after fully informed and they participate voluntarily and sign the informed consent form.

Exclusion Criteria

•Known hypersensitivity to any ingredient in the experimental drug.
•Patients with severe or critical COVID-
•With abnormal liver function observed at the time of screening: total bilirubin ≥ 2 × upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN.
•Subjects with liver diseases, including but not limited to the following diseases, which may affect the safety or efficacy evaluation of subjects during the trial as assessed by the investigator:primary biliary cirrhosis、Child-Pugh Class B or C、acute liver failure.
•Subjects with known human immunodeficiency virus (HIV) infection.
•Abnormal renal function observed at the time of screening: serum creatinine ≥ 1.5×ULN;or patients receiving continuous renal replacement therapy, hemodialysis, and peritoneal dialysis at the time of screening.
•Subjects with acute exacerbation of chronic respiratory diseases.
•Suspected or confirmed acute systemic infections other than COVID-19 observed at the time of screening.
•Complications requiring surgery before randomized trial or during the entire trial period and major surgery operated 14 days before the randomized trial,or life-threatening comorbidities considered by the investigator within 30 days before the randomized trial.
•Cardiovascular diseases meeting any of the following criteria:History of myocardial infarction within the past 12 months、Unstable angina、Clinically significant and uncontrollable cardiac arrhythmias、History of stroke or transient ischemic attack requiring drug treatment in the past 12 months、Congestive heart failure of grade ≥ II assessed by New York Heart Association (NYHA)、Localized edema of grade ≥3、Clinically uncontrolled hypertension.

Arms & Interventions

SHEN26

Participants will receive SHEN26 400mg twice daily for 5 days.

Intervention: SHEN26 capsule

SHEN26 placebo

Participants will receive SHEN26 placebo twice daily for 5 days.

Intervention: SHEN26 placebo

Outcomes

Primary Outcomes

Time to 11 COVID-19 Symptom Resolution by Day 28

Time Frame: Day 1 up to 28

The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days

Secondary Outcomes

Time to 5 COVID-19 Symptom Resolution by Day 28(Day 1 up to 28)
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test(baseline, Day 3, Day 5, and Day 7)
Time to sustained alleviation of 11 COVID-19 symptoms(Day 1 up to 28)
AE(Day 1 up to 28)
Change of viral load compared to the baseline(Baseline, Day 7)
Proportion of Participants with All-cause Death(Day 1 up to 28)
Proportion of Participants with COVID-19 related Hospitalization(Day 1 up to 28)
Proportion of severe or critical Participants(Day 1 up to 28)