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

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)

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.

Study Overview

• Status: Completed
• Conditions: Novel Coronavirus Pneumonia
• Intervention / Treatment: Drug: Tanreqing capsule; Drug: Tanreqing capsule simulator

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.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China, 200093
      • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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；
2. Aged greater than 18, with no gender limitation;
3. Symptom score greater than or equal 3 points;
4. 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.

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
Experimental: Tanreqing capsule; 3 capsules per time, 3 times a day，7 days of treatment	Drug: Tanreqing capsule; 3 capsules per time, 3 times a day; Other Names: Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.
Placebo Comparator: Tanreqing capsule simulator; 3 capsules per time, 3 times a day，7 days of treatment	Drug: Tanreqing capsule simulator; 3 capsules per time, 3 times a day; Other Names: Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 days
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.	8 days
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.	8 days
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.	8 days
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.	90 days

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.
• Collaborators: Ruijin Hospital
• Investigators: Principal Investigator: Zhao Ren, PhD, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (North Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: mild, common
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• Other Study ID Numbers: FM-P8-2022032501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No