Study Evaluating SHEN26 Capsule in Patients With Mild to Moderate COVID-19

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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: SHEN26 capsule; Drug: SHEN26 placebo

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dandan Xu; Phone Number: +8618038100512; Email: xudandan@kexing.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Known hypersensitivity to any ingredient in the experimental drug.
2. Patients with severe or critical COVID-19.
3. 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.
4. 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.
5. Subjects with known human immunodeficiency virus (HIV) infection.
6. 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.
7. Subjects with acute exacerbation of chronic respiratory diseases.
8. Suspected or confirmed acute systemic infections other than COVID-19 observed at the time of screening.
9. 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.
10. 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.
11. Received SARS-CoV-2 monoclonal antibody treatment or prevention within 30 days before the randomized trial.
12. Received convalescent COVID-19 patient plasma or COVID-19 human immunoglobulin therapy within 30 days before the randomized trial.
13. Have taken antiviral drugs within 30 days before the randomized trial.
14. Have taken any COVID-19 vaccine within 3 months or have been infected with new coronavirus within 3 months before the randomized trial.
15. Pregnant and lactating women.
16. Have participated in other clinical trials or are using experimental drugs within 3 months before the randomized trial.
17. Under other conditions that are not suitable for participating in this trial assessed by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: SHEN26 placebo; Participants will receive SHEN26 placebo twice daily for 5 days.	Drug: SHEN26 placebo; Capsule administered orally after meals.
Experimental: SHEN26; Participants will receive SHEN26 400mg twice daily for 5 days.	Drug: SHEN26 capsule; Capsule administered orally after meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to 11 COVID-19 Symptom Resolution by Day 28	The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days	Day 1 up to 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of viral load compared to the baseline		Baseline, Day 3, and Day 5
Time to 5 COVID-19 Symptom Resolution by Day 28	The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 for two consecutive days	Day 1 up to 28
Change of viral load compared to the baseline		Baseline, Day 7
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	The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 or 1 for two consecutive days	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
Proportion of Participants with All-cause Death		Day 1 up to 28
AE	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Day 1 up to 28

Collaborators and Investigators

• Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: KXZY-SHEN26-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No