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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHEN26 dose 1
SHEN26 dose 2
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Fully understand the trial's purpose, nature, methods, and possible adverse effects, volunteer as a subject, and sign the informed consent form. Subjects and their female partners are willing to have no childbearing plans and voluntarily use effective contraception and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and pledge to use one or more non-pharmacological contraceptives during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug. Age 18-65 years (including boundary values, based on the time of signing the informed consent form) of either sex. Positive results for SARS-CoV-2 using RT-PCR (Ct value< 25) in nasopharyngeal swab samples with the first positive nucleic acid test collected ≤ 5 days from Day 1 administration. Patients with a diagnosis of mild or moderate COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9). Liver function indicators meet the criteria of: Alanine aminotransferase (ALT) ≤ 3 × ULN; Aspartate aminotransferase (AST) ≤ 3 × ULN; Total bilirubin (TBIL) ≤ 2 × ULN. Hemoglobin (Hb) ≥ 90 g/L. Platelets ≥ 100 × 10^9 /L. Blood creatinine converted endogenous creatinine clearance (Ccr) > 60 mL/min (according to the Cockcroft-Gault formula). Exclusion Criteria: Subjects diagnosed with severe or critical COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) or who, in the judgment of the investigator, are likely to progress to severe/critical COVID-19 prior to randomization. Subjects are expected to be transferred to another hospital prior to randomization or within 72 hours of enrollment. Subjects with SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30 breaths/minute, or heart rate ≥ 125 beats/minute while breathing room air at sea level for 24 hours prior to dosing. Subjects who require mechanical ventilation or are expected to require mechanical ventilation. Subjects infected with COVID-19 within 3 months prior to dosing. Subjects who have received SARS-CoV-2 monoclonal antibody treatment or prophylaxis within 30 days prior to dosing. Subjects who have received COVID-19 convalescent plasma or COVID-19 human immunoglobulin treatment within 30 days prior to dosing. Subjects who have received treatment or prophylaxis with antiviral drugs (e.g., Paxlovid, Molnupiravir, Remdesivir, lopinavir/ritonavir combination, ribavirin, chloroquine, hydroxychloroquine, etc.) within 30 days prior to dosing. Subjects who have received systemic or inhaled steroids for COVID-19 treatment within 30 days prior to dosing (except for long-term stable dose treatment with concomitant chronic disease and no dose increase). Subjects who are on dialysis. Subjects with a history of drug or other allergies or who, in the investigator's judgment, may be allergic to the test drug or any component of the test drug. Subjects who have undergone major organ surgery (excluding puncture biopsy, tracheotomy, gastrostomy, etc.) or significant trauma within 28 days prior to dosing or who require elective surgery during the trial period. Subjects with a life-threatening illness within 28 days prior to dosing, or other clinically significant illness as judged by the investigator. Cardiovascular disease meeting any of the following criteria: Prior history of myocardial infarction within 12 months; Unstable angina pectoris; Clinically significant and uncontrollable cardiac arrhythmia; A history of stroke or transient ischemic attack requiring medication in the past 12 months; Congestive heart failure based on NYHA classification ≥ Class II; Restrictive edema of ≥ grade 3 (including respiratory, chest and mediastinal disease: laryngeal edema, pulmonary edema; skin and subcutaneous tissue disease: peripheral edema); Clinically uncontrollable hypertension. Subjects with suspected or confirmed active systemic infections, such as bacterial, fungal, viral or other infections (other than COVID-19 infections), or with conditions that, in the investigator's judgment, would affect the assessment of endpoints in this study. Subjects with known HIV infection, or human immunodeficiency virus antibody (HIV-Ab) positive at screening. Subjects with liver disease meeting any of the following criteria: Known active HBV infection (subjects with a history of hepatitis B or previous hepatitis B surface antigen positivity but whose liver function at baseline meets the inclusion criteria and is judged by the investigator to be stable may be enrolled); Known HCV infection; Primary biliary cirrhosis; Child-Pugh Class B or C; Acute liver failure. Subjects who have difficulty with venous blood collection or have a history of acupuncture and blood sickness. Female subjects who have tested positive for pregnancy or are breastfeeding during the screening or baseline period. Subjects who have participated in other drug clinical trials and used other clinical trial drugs within 1 month prior to screening. Subjects who have received any vaccine within 1 month prior to screening or subjects who are scheduled to receive vaccines (including COVID-19 vaccine boosters) during the trial. Any other circumstances that, in the investigator's opinion, may affect the subject's ability to provide informed consent or follow the trial protocol, or the subject's participation in the trial may affect the trial results or their own safety.

Sites / Locations

  • Guangdong Second Provincial General Hospital
  • The Third People's Hospital of Shenzhen
  • Shenzhen Longhua District People's Hospital
  • Shijiazhuang Fifth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SHEN26 dose 1

SHEN26 dose 2

SHEN26 placebo

Arm Description

SHEN26 capsule 200mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).

SHEN26 capsule 400mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).

Placebo matching the SHEN26 capsule. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).

Outcomes

Primary Outcome Measures

SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR) on Day 7

Secondary Outcome Measures

TEAEs and SAEs
The incidence of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs).
AEs leading to discontinuation of treatment
The incidence of AEs leading to discontinuation of study treatment.
Drug-related treatment discontinuation
The incidence of drug-related study treatment discontinuation.
New AEs of Grade 3 or higher
The incidence of new Grade 3 or higher AE (not present at baseline). The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
New drug-related AEs of Grade 3 or higher
Incidence of new drug-related AEs of Grade 3 or higher. The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
SARS-CoV-2 viral RNA level (RT-PCR) at prespecified timepoints
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR)
Time to achieve SARS-CoV-2 viral clearance
Viral clearance is defined as two consecutive viral nucleic acid assays with Ct values ≥35 for both N and ORF genes by RT-PCR and an interval of ≥24 hours between sampling. The date of achieving clearance is calculated as the date of the first Ct value ≥ 35).
Percentage of participants achieving SARS-CoV-2 viral clearance at prespecified timepoints
The change in percentage of participants achieving SARS-CoV-2 viral clearance.
Plasma concentrations of SHEN26-69-0 on Day 5
Time to achieve sustained alleviation of COVID-19 symptoms
Time to achieve sustained alleviation of 11 symptoms of COVID-19 after the first dose, with sustained alleviation defined as a related symptom score of 0 to 1 and lasting ≥ 48 hours. The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.
Time to achieve sustained recovery of COVID-19 symptoms
Time to achieve sustained recovery of 11 symptoms of COVID-19 after the first dose, with sustained recovery defined as a relevant symptom score of 0 and lasting ≥ 48 hours. The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.

Full Information

First Posted
January 3, 2023
Last Updated
June 15, 2023
Sponsor
Shenzhen Kexing Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05676073
Brief Title
Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19
Official Title
A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHEN26 Capsule in Patients With Mild to Moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 27, 2023 (Actual)

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
No

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate COVID-19.
Detailed Description
Eligible patients with mild to moderate COVID-19 will be randomized in a 1:1:1 ratio to SHEN26 low dose group (200 mg), SHEN26 high dose group (400 mg), and placebo group, with 30 patients in each group.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHEN26 dose 1
Arm Type
Experimental
Arm Description
SHEN26 capsule 200mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).
Arm Title
SHEN26 dose 2
Arm Type
Experimental
Arm Description
SHEN26 capsule 400mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).
Arm Title
SHEN26 placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching the SHEN26 capsule. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).
Intervention Type
Drug
Intervention Name(s)
SHEN26 dose 1
Intervention Description
Specification: 200mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
Intervention Type
Drug
Intervention Name(s)
SHEN26 dose 2
Intervention Description
Specification: 400mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
Intervention Type
Drug
Intervention Name(s)
SHEN26 placebo
Intervention Description
Placebo matching the SHEN26 capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
Primary Outcome Measure Information:
Title
SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Description
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
TEAEs and SAEs
Description
The incidence of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs).
Time Frame
From Baseline up to Day 28
Title
AEs leading to discontinuation of treatment
Description
The incidence of AEs leading to discontinuation of study treatment.
Time Frame
From Baseline up to Day 28
Title
Drug-related treatment discontinuation
Description
The incidence of drug-related study treatment discontinuation.
Time Frame
From Baseline up to Day 28
Title
New AEs of Grade 3 or higher
Description
The incidence of new Grade 3 or higher AE (not present at baseline). The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
Time Frame
From Baseline up to Day 28
Title
New drug-related AEs of Grade 3 or higher
Description
Incidence of new drug-related AEs of Grade 3 or higher. The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
Time Frame
From Baseline up to Day 28
Title
SARS-CoV-2 viral RNA level (RT-PCR) at prespecified timepoints
Description
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR)
Time Frame
Day 3, Day 5, Day 7, Day 10, Day 28
Title
Time to achieve SARS-CoV-2 viral clearance
Description
Viral clearance is defined as two consecutive viral nucleic acid assays with Ct values ≥35 for both N and ORF genes by RT-PCR and an interval of ≥24 hours between sampling. The date of achieving clearance is calculated as the date of the first Ct value ≥ 35).
Time Frame
From Baseline up to Day 28
Title
Percentage of participants achieving SARS-CoV-2 viral clearance at prespecified timepoints
Description
The change in percentage of participants achieving SARS-CoV-2 viral clearance.
Time Frame
Day 3, Day 5, Day 7, Day 10, Day 28
Title
Plasma concentrations of SHEN26-69-0 on Day 5
Time Frame
Day 5
Title
Time to achieve sustained alleviation of COVID-19 symptoms
Description
Time to achieve sustained alleviation of 11 symptoms of COVID-19 after the first dose, with sustained alleviation defined as a related symptom score of 0 to 1 and lasting ≥ 48 hours. The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.
Time Frame
From Day 1 up to Day 28
Title
Time to achieve sustained recovery of COVID-19 symptoms
Description
Time to achieve sustained recovery of 11 symptoms of COVID-19 after the first dose, with sustained recovery defined as a relevant symptom score of 0 and lasting ≥ 48 hours. The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.
Time Frame
From Day 1 up to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fully understand the trial's purpose, nature, methods, and possible adverse effects, volunteer as a subject, and sign the informed consent form. Subjects and their female partners are willing to have no childbearing plans and voluntarily use effective contraception and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and pledge to use one or more non-pharmacological contraceptives during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug. Age 18-65 years (including boundary values, based on the time of signing the informed consent form) of either sex. Positive results for SARS-CoV-2 using RT-PCR (Ct value< 25) in nasopharyngeal swab samples with the first positive nucleic acid test collected ≤ 5 days from Day 1 administration. Patients with a diagnosis of mild or moderate COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9). Liver function indicators meet the criteria of: Alanine aminotransferase (ALT) ≤ 3 × ULN; Aspartate aminotransferase (AST) ≤ 3 × ULN; Total bilirubin (TBIL) ≤ 2 × ULN. Hemoglobin (Hb) ≥ 90 g/L. Platelets ≥ 100 × 10^9 /L. Blood creatinine converted endogenous creatinine clearance (Ccr) > 60 mL/min (according to the Cockcroft-Gault formula). Exclusion Criteria: Subjects diagnosed with severe or critical COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) or who, in the judgment of the investigator, are likely to progress to severe/critical COVID-19 prior to randomization. Subjects are expected to be transferred to another hospital prior to randomization or within 72 hours of enrollment. Subjects with SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30 breaths/minute, or heart rate ≥ 125 beats/minute while breathing room air at sea level for 24 hours prior to dosing. Subjects who require mechanical ventilation or are expected to require mechanical ventilation. Subjects infected with COVID-19 within 3 months prior to dosing. Subjects who have received SARS-CoV-2 monoclonal antibody treatment or prophylaxis within 30 days prior to dosing. Subjects who have received COVID-19 convalescent plasma or COVID-19 human immunoglobulin treatment within 30 days prior to dosing. Subjects who have received treatment or prophylaxis with antiviral drugs (e.g., Paxlovid, Molnupiravir, Remdesivir, lopinavir/ritonavir combination, ribavirin, chloroquine, hydroxychloroquine, etc.) within 30 days prior to dosing. Subjects who have received systemic or inhaled steroids for COVID-19 treatment within 30 days prior to dosing (except for long-term stable dose treatment with concomitant chronic disease and no dose increase). Subjects who are on dialysis. Subjects with a history of drug or other allergies or who, in the investigator's judgment, may be allergic to the test drug or any component of the test drug. Subjects who have undergone major organ surgery (excluding puncture biopsy, tracheotomy, gastrostomy, etc.) or significant trauma within 28 days prior to dosing or who require elective surgery during the trial period. Subjects with a life-threatening illness within 28 days prior to dosing, or other clinically significant illness as judged by the investigator. Cardiovascular disease meeting any of the following criteria: Prior history of myocardial infarction within 12 months; Unstable angina pectoris; Clinically significant and uncontrollable cardiac arrhythmia; A history of stroke or transient ischemic attack requiring medication in the past 12 months; Congestive heart failure based on NYHA classification ≥ Class II; Restrictive edema of ≥ grade 3 (including respiratory, chest and mediastinal disease: laryngeal edema, pulmonary edema; skin and subcutaneous tissue disease: peripheral edema); Clinically uncontrollable hypertension. Subjects with suspected or confirmed active systemic infections, such as bacterial, fungal, viral or other infections (other than COVID-19 infections), or with conditions that, in the investigator's judgment, would affect the assessment of endpoints in this study. Subjects with known HIV infection, or human immunodeficiency virus antibody (HIV-Ab) positive at screening. Subjects with liver disease meeting any of the following criteria: Known active HBV infection (subjects with a history of hepatitis B or previous hepatitis B surface antigen positivity but whose liver function at baseline meets the inclusion criteria and is judged by the investigator to be stable may be enrolled); Known HCV infection; Primary biliary cirrhosis; Child-Pugh Class B or C; Acute liver failure. Subjects who have difficulty with venous blood collection or have a history of acupuncture and blood sickness. Female subjects who have tested positive for pregnancy or are breastfeeding during the screening or baseline period. Subjects who have participated in other drug clinical trials and used other clinical trial drugs within 1 month prior to screening. Subjects who have received any vaccine within 1 month prior to screening or subjects who are scheduled to receive vaccines (including COVID-19 vaccine boosters) during the trial. Any other circumstances that, in the investigator's opinion, may affect the subject's ability to provide informed consent or follow the trial protocol, or the subject's participation in the trial may affect the trial results or their own safety.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu, MD, PhD
Organizational Affiliation
Shenzhen Third People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Second Provincial General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510317
Country
China
Facility Name
The Third People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518112
Country
China
Facility Name
Shenzhen Longhua District People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Shijiazhuang Fifth Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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