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Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19

Primary Purpose

Novel Coronavirus Pneumonia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tanreqing capsule
Tanreqing capsule simulator
Sponsored by
Jiangsu Famous Medical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Novel Coronavirus Pneumonia focused on measuring mild, common

Eligibility Criteria

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

Inclusion Criteria:

  1. Those who conform to the diagnosis of novel coronavirus pneumonia according to the Novel Coronavirus Diagnosis and Treatment Protocol for Pneumonia (Trial Edition 9) and are clinically classified as mild or ordinary type;
  2. Aged between 18 and 75, with no gender limitation;
  3. Voluntarily accept the drug treatment and sign the informed consent.

Exclusion Criteria:

  1. Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19;
  2. immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months;
  3. pregnant and lactating women;
  4. People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study);
  5. mentally ill persons or persons without self-awareness;
  6. Patients whose expected survival time from screening is not more than 48 hours; (7) those who have been intubated or mechanically ventilated at the time of screening;

(8) In patients with serious primary diseases of heart, brain, liver and kidney, ALT and AST were 1.5 times higher than the upper limit of normal value; (9) Other conditions that the investigator considers inappropriate for clinical trial participation.

Sites / Locations

  • Huashan Hospital Affiliated to Fudan University
  • Shanghai Public Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tanreqing capsule

Tanreqing capsule simulator

Arm Description

3 capsules per time, 3 times a day，7 days of treatment

3 capsules per time, 3 times a day，7 days of treatment

Outcomes

Primary Outcome Measures

The time from the first dose to sustained clinical recovery
Symptom domains and minors disappear completely within 7 days treatment period after randomization, and maintain it for 2 days without recurrence and the disease don't aggravate

Secondary Outcome Measures

Novel coronavirus N and ORF gene changes
Nucleic acid detection was performed on the 0, 1, 2, 3, 4, 5, 6 and 7 days respectively. The fluorescent quantitative PCR method was used to determine the Ct value of N gene and ORF gene in novel coronavirus nucleic acid detection. Negative: no Ct value or Ct value>40. Positive: Ct value<35. Ct value (cycle threshold) refers to the Ct value of nucleic acid detection, that is, the number of cycles required when the pcr fluorescence signal reaches the threshold.
The time from the first dose/first testing positive of virus to testing sustained negative of virus within 7 days treatment period after randomization
Testing sustained negative of virus was defined two consecutive (at least 24 hours apart) nasal swabs with new coronavirus nucleic acid detection CT values 35 ,and the negative event date was defined by first negative occurrence.
Effective rate of wind heat attacking lung syndrome
The time from the first dose to sustained clinical improvement defined total scores for symptom domains and minors was <3 within 7 days treatment period after randomization.
Duration of disappearance of main symptoms of wind heat attacking lung syndrome
The time from the first dose to sustained complete disappearance within 7 days treatment period after randomization for every symptom domain, and these two outcomes definition were similar to the primary outcome.
Weight conversion rate (ratio of light type to ordinary type and ordinary type to heavy type)
Proportion of patient experiencing progression to severe illness diagnosed by Trial draft version 9 of Diagnosis and Treatment Protocol for novel Coronavirus pneumonia within 7 days treatment period after randomization, during period from the end of 7 days treatment period to discharged from hospital and 3-month follow-up period after discharge.

Full Information

First Posted
March 30, 2022
Last Updated
December 5, 2022
Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
Collaborators
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05305456
Brief Title
Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Tanreqing Capsule Efficacy and Safety in the Treatment of COVID-19 (Mild and Common Type)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
Collaborators
Ruijin Hospital

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 study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
Detailed Description
The purpose of this study was to evaluate the efficacy and safety of Tanreqing capsule in the treatment of mild and common COVID-19. The trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial design. A total of 480 patients were divided into 2 groups: experimental group and control group 3:1. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Novel Coronavirus Pneumonia
Keywords
mild, common

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tanreqing capsule
Arm Type
Experimental
Arm Description
3 capsules per time, 3 times a day，7 days of treatment
Arm Title
Tanreqing capsule simulator
Arm Type
Placebo Comparator
Arm Description
3 capsules per time, 3 times a day，7 days of treatment
Intervention Type
Drug
Intervention Name(s)
Tanreqing capsule
Other Intervention Name(s)
Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.
Intervention Description
3 capsules per time, 3 times a day
Intervention Type
Drug
Intervention Name(s)
Tanreqing capsule simulator
Other Intervention Name(s)
Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.
Intervention Description
3 capsules per time, 3 times a day
Primary Outcome Measure Information:
Title
The time from the first dose to sustained clinical recovery
Description
Symptom domains and minors disappear completely within 7 days treatment period after randomization, and maintain it for 2 days without recurrence and the disease don't aggravate
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Novel coronavirus N and ORF gene changes
Description
Nucleic acid detection was performed on the 0, 1, 2, 3, 4, 5, 6 and 7 days respectively. The fluorescent quantitative PCR method was used to determine the Ct value of N gene and ORF gene in novel coronavirus nucleic acid detection. Negative: no Ct value or Ct value>40. Positive: Ct value<35. Ct value (cycle threshold) refers to the Ct value of nucleic acid detection, that is, the number of cycles required when the pcr fluorescence signal reaches the threshold.
Time Frame
8 days
Title
The time from the first dose/first testing positive of virus to testing sustained negative of virus within 7 days treatment period after randomization
Description
Testing sustained negative of virus was defined two consecutive (at least 24 hours apart) nasal swabs with new coronavirus nucleic acid detection CT values 35 ,and the negative event date was defined by first negative occurrence.
Time Frame
8 days
Title
Effective rate of wind heat attacking lung syndrome
Description
The time from the first dose to sustained clinical improvement defined total scores for symptom domains and minors was <3 within 7 days treatment period after randomization.
Time Frame
8 days
Title
Duration of disappearance of main symptoms of wind heat attacking lung syndrome
Description
The time from the first dose to sustained complete disappearance within 7 days treatment period after randomization for every symptom domain, and these two outcomes definition were similar to the primary outcome.
Time Frame
8 days
Title
Weight conversion rate (ratio of light type to ordinary type and ordinary type to heavy type)
Description
Proportion of patient experiencing progression to severe illness diagnosed by Trial draft version 9 of Diagnosis and Treatment Protocol for novel Coronavirus pneumonia within 7 days treatment period after randomization, during period from the end of 7 days treatment period to discharged from hospital and 3-month follow-up period after discharge.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: According to the Diagnosis and Treatment Plan for Pneumonia Infected by novel coronavirus (Trial Version 9), those who are in line with the diagnosis of novel coronavirus pneumonia and whose clinical classification is light and ordinary； Aged greater than 18, with no gender limitation; Symptom score greater than or equal 3 points; Voluntarily accept the drug treatment and sign the informed consent. Exclusion Criteria: Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19; immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months; pregnant and lactating women; People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study); mentally ill persons or persons without self-awareness; Patients whose expected survival time from screening is not more than 48 hours; (7) those who have been intubated or mechanically ventilated at the time of screening; (8) In patients with serious primary diseases of heart, brain, liver and kidney, ALT and AST were 1.5 times higher than the upper limit of normal value; (9) Other conditions that the investigator considers inappropriate for clinical trial participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Ren, PhD
Organizational Affiliation
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (North Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200093
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19

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