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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHEN26 capsule
SHEN26 placebo
Sponsored by
Shenzhen Kexing Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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-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. Have participated in other clinical trials or are using experimental drugs within 3 months before the randomized trial. Under other conditions that are not suitable for participating in this trial assessed by the investigator.

Sites / Locations

  • The First Affiliated Hospital Of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SHEN26

SHEN26 placebo

Arm Description

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

Participants will receive SHEN26 placebo twice daily for 5 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of viral load compared to the baseline
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
Change of viral load compared to the baseline
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
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
Proportion of Participants with COVID-19 related Hospitalization
Proportion of severe or critical Participants
Proportion of Participants with All-cause Death
AE
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
June 15, 2023
Last Updated
June 19, 2023
Sponsor
Shenzhen Kexing Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05908071
Brief Title
Study Evaluating SHEN26 Capsule in Patients With Mild to Moderate COVID-19
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Kexing Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHEN26
Arm Type
Experimental
Arm Description
Participants will receive SHEN26 400mg twice daily for 5 days.
Arm Title
SHEN26 placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive SHEN26 placebo twice daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
SHEN26 capsule
Intervention Description
Capsule administered orally after meals.
Intervention Type
Drug
Intervention Name(s)
SHEN26 placebo
Intervention Description
Capsule administered orally after meals.
Primary Outcome Measure Information:
Title
Time to 11 COVID-19 Symptom Resolution by Day 28
Description
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days
Time Frame
Day 1 up to 28
Secondary Outcome Measure Information:
Title
Change of viral load compared to the baseline
Time Frame
Baseline, Day 3, and Day 5
Title
Time to 5 COVID-19 Symptom Resolution by Day 28
Description
The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 for two consecutive days
Time Frame
Day 1 up to 28
Title
Change of viral load compared to the baseline
Time Frame
Baseline, Day 7
Title
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time Frame
baseline, Day 3, Day 5, and Day 7
Title
Time to sustained alleviation of 11 COVID-19 symptoms
Description
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
Time Frame
Day 1 up to 28
Title
Proportion of Participants with COVID-19 related Hospitalization
Time Frame
Day 1 up to 28
Title
Proportion of severe or critical Participants
Time Frame
Day 1 up to 28
Title
Proportion of Participants with All-cause Death
Time Frame
Day 1 up to 28
Title
AE
Description
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Day 1 up to 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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-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. Have participated in other clinical trials or are using experimental drugs within 3 months before the randomized trial. Under other conditions that are not suitable for participating in this trial assessed by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dandan Xu
Phone
+8618038100512
Email
xudandan@kexing.com
Facility Information:
Facility Name
The First Affiliated Hospital Of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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