Kesuting Syrup in the Treatment of Corona Virus Disease 2019 (COVID-19)

A Randomized, Open-label, Positive Drug Parallel Controlled Clinical Trial of Kesuting Syrup in the Treatment of COVID-19 (Light)

This trial is an exploratory study, aiming to explore the preliminary efficacy and safety of Kesuting Syrup in the treatment of novel coronavirus pneumonia. It is planned to include a total of 200 cases. Kesuting Syrup test group: Lianhua Qingwen Granules control group = 1:1, each 100 cases in each group.

Study Overview

• Status: Completed
• Conditions: Cough; COVID-19 Pneumonia
• Intervention / Treatment: Drug: Kesuting syrup; Drug: LianHuaQingWen Granules

Detailed Description

This trial is a randomized, open-label, parallel-controlled clinical trial of active drugs.With reference to"Diagnosis and Treatment Protocol for COVID-19(Trial Version 9)", Lianhua Qingwen Granules have been recommended for mild and common patients during the medical observation period and clinical treatment period of the new coronavirus. The purpose of the experiment is preliminary evaluate the clinical efficacy and safety of Kesuting syrup in the treatment of COVID-19 (Light) .

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Persons with COVID-19 (Light) in accordance with the "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)" .
2. Subjects with cough score > 1.
3. Inpatients aged 18 ≤ age ≤ 75 years old, regardless of gender.
4. Subjects (including male subjects) who have no plans for pregnancy, sperm donation, or egg donation in the past six months, and who are willing to take effective contraceptive measures from the first dose to 3 months after the last dose.
5. Subjects fully understand the purpose, nature, content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Ordinary, severe, and critically ill patients with novel coronavirus pneumonia, or patients with novel coronavirus pneumonia requiring mechanical ventilation.
2. patients with asthma attack, suppurative tonsillitis, acute and chronic bronchitis, sinusitis, otitis media and other respiratory diseases that affect clinical trial evaluation; And chest CT confirmed the existence of severe pulmonary interstitial lesions, bronchiectasis, obstructive pulmonary disease and other basic pulmonary diseases.
3. Patients with respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development.
4. According to the judgment of the investigator, past or current chronic or serious diseases may affect participation in the trial or the outcome of the study, including but not limited to gastrointestinal system, cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, lymphatic system Patients with diseases of the system, endocrine system, immune system, malignant tumor, severe malnutrition, nervous system and endocrine system,as well as those currently suffering from human immunodeficiency virus (HIV) infection, splenectomy, organ transplantation and other diseases that seriously affect the immune system.
5. Those who cannot cooperate in mental state, those who suffer from mental illness, cannot control themselves, and cannot express themselves clearly.
6. Patients with diabetes.
7. Patients with poorly controlled hypertension: low pressure ≥110 mmHg or high pressure ≥180 mmHg.
8. Alanine Aminotransterase（ALT）and Aspartate Aminotransferase（AST） ≥ 1.5 times the upper limit of normal, and Scr > the upper limit of normal.
9. Those who have a history of specific allergies (such as asthma, measles, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, foods such as milk and pollen), or are allergic to the drug ingredients of Kesuting Syrup and Lianhua Qingwen Granules.
10. Those with a history of drug abuse or dependence within 6 months before randomization.
11. Those who have used any Chinese and Western medicines to relieve cough and reduce phlegm within 24 hours before randomization.
12. Pregnant and lactating female patients.
13. Patients who have participated in or are participating in clinical trials of other drugs within 3 months prior to screening.
14. Investigators deem others unsuitable to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kesuting syrup group; Kesuting syrup, the tested drug of this study.	Drug: Kesuting syrup; Conventional treatment + Kesuting Syrup, take orally, 20 ml once, three times a day.Conventional treatment refer to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)". Except for the test drugs, during the observation period, it is prohibited to use other Chinese and Western medicines for cough and phlegm elimination for treatment. If combined use is required, it shall be recorded truthfully.; Other Names: Kesuting Tangjiang
Active Comparator: LianHuaQingWen Granules Control group; LianHuaQingWen Granules, referring to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9)", a NMPA approved drug for light and common patients with novel coronavirus during medical observation and clinical treatment,is adopted as active comparator in this study.	Drug: LianHuaQingWen Granules; Conventional treatment + LianHuaQingWen Granules, orally, 1 bag at a time, 3 times a day.Conventional treatment refer to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)".Except for the test drugs, during the observation period, it is prohibited to use other Chinese and Western medicines for cough and phlegm elimination for treatment. If combined use is required, it shall be recorded truthfully.; Other Names: Lianhua Qingwen Keli

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough efficacy assessed by cough symptom scale（CSS）	Recording and evaluation of cough symptom scores by CSS(evaluation standards on the basis of the diagnosis and treatment of coughing guide (2015)),included daytime and nighttime cough symptom assessments,0 for normal, 1 for mild, 2 for moderate and 3 for severe,scores added.	at baseline
Cough efficacy by cough symptom scale（CSS）	Recording and evaluation of cough symptom scores by CSS(evaluation standards on the basis of the diagnosis and treatment of coughing guide (2015)),included daytime and nighttime cough symptom assessments,0 for normal, 1 for mild, 2 for moderate and 3 for severe,scores added.	at 7 days of medication
Cough efficacy by cough symptom scale（CSS）	Recording and evaluation of cough symptom scores by CSS(evaluation standards on the basis of the diagnosis and treatment of coughing guide (2015)),included daytime and nighttime cough symptom assessments,0 for normal, 1 for mild, 2 for moderate and 3 for severe,scores added.	up to 14 days
Cough disappearance time	Change from Baseline，record the time in hour it takes for the cough to go away .	Baseline, at cough disappears up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease recovery time	Evaluation of treatment endpoints	up to 14 days
Disease recovery rate	Evaluation of treatment endpoints	up to 14 days
The time of negative conversion of new coronavirus.	Record the time of negative conversion of new coronavirus.	at baseline, 7 days of medication, up to 14 days
The rate of negative conversion of new coronavirus.	Record rate of negative conversion of new coronavirus.	at baseline, 7 days of medication, up to 14 days
Efficacy of fever assessed by the single symptom grading standard formulated	Change from baseline individual symptoms (fever）markedly effective, effective or ineffective)at 7 days of medication and end of treatment,up to 14 days,according to the single symptom grading standard formulated.	at baseline, 7 days of medication,up to 14 days
Efficacy of fatigue assessed by the single symptom grading standard formulated	Change from baseline individual symptoms (fatigue）markedly effective, effective or ineffective)at 7 days of medication and end of treatment,up to 14 days,according to the single symptom grading standard formulated.	at baseline, 7 days of medication,up to 14 days
Efficacy of sore throat assessed by the single symptom grading standard formulated	Change from baseline individual symptoms ( sore throat)markedly effective, effective or ineffective)at 7 days of medication and end of treatment,up to 14 days,according to the single symptom grading standard formulated.	at baseline, 7 days of medication,up to 14 days
Incidence of severe/critical illness	Assess the incidence of severe/critical illness	up to 14 days

Collaborators and Investigators

• Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
• Investigators: Principal Investigator: Yun Ling, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Kesuting syrup
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: KST-22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No