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

NCT05908071 | Unknown Phase 3 DMC

• 1 other identifier: KXZY-SHEN26-301
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change of viral load compared to the baseline

  Baseline, Day 3, and Day 5

• Time to 5 COVID-19 Symptom Resolution by Day 28

  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

  Day 1 up to 28

Study Arms (2)

SHEN26

EXPERIMENTAL

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

Drug: SHEN26 capsule

SHEN26 placebo

PLACEBO COMPARATOR

Participants will receive SHEN26 placebo twice daily for 5 days.

Drug: SHEN26 placebo

Interventions

SHEN26 capsule DRUG

Capsule administered orally after meals.

SHEN26

SHEN26 placebo DRUG

Capsule administered orally after meals.

SHEN26 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, 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.

You may not qualify if:

• Known hypersensitivity to any ingredient in the experimental drug.
• Patients with severe or critical COVID-19.
• 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.
• Received SARS-CoV-2 monoclonal antibody treatment or prevention within 30 days before the randomized trial.
• Received convalescent COVID-19 patient plasma or COVID-19 human immunoglobulin therapy within 30 days before the randomized trial.
• Have taken antiviral drugs within 30 days before the randomized trial.
• Have taken any COVID-19 vaccine within 3 months or have been infected with new coronavirus within 3 months before the randomized trial.
• Pregnant and lactating women.

Sponsors & Collaborators

• Shenzhen Kexing Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

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

Central Study Contacts

Dandan Xu

CONTACT

+8618038100512; xudandan@kexing.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 18, 2023
• Study Start: May 13, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)