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

NCT05366231 | Completed Phase 4

• 1 other identifier: KST-22-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Pneumonia; Cough

Keywords

Kesuting syrup; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Disease recovery time

  up to 14 days

• Disease recovery rate

  up to 14 days

• 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.

  at baseline, 7 days of medication, up to 14 days

• Efficacy of fever assessed by the single symptom grading standard formulated

  at baseline, 7 days of medication,up to 14 days

Study Arms (2)

Kesuting syrup group

EXPERIMENTAL

Kesuting syrup, the tested drug of this study.

Drug: Kesuting syrup

LianHuaQingWen Granules Control group

ACTIVE COMPARATOR

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

Interventions

Kesuting syrup DRUG

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.

Also known as: Kesuting Tangjiang

Kesuting syrup group

LianHuaQingWen Granules DRUG

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.

Also known as: Lianhua Qingwen Keli

LianHuaQingWen Granules Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with COVID-19 (Light) in accordance with the "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)" .
• Subjects with cough score \> 1.
• Inpatients aged 18 ≤ age ≤ 75 years old, regardless of gender.
• 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.
• Subjects fully understand the purpose, nature, content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form.

You may not qualify if:

• Ordinary, severe, and critically ill patients with novel coronavirus pneumonia, or patients with novel coronavirus pneumonia requiring mechanical ventilation.
• 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.
• 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.
• 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.
• Those who cannot cooperate in mental state, those who suffer from mental illness, cannot control themselves, and cannot express themselves clearly.
• Patients with diabetes.
• Patients with poorly controlled hypertension: low pressure ≥110 mmHg or high pressure ≥180 mmHg.
• Alanine Aminotransterase（ALT）and Aspartate Aminotransferase（AST） ≥ 1.5 times the upper limit of normal, and Scr \> the upper limit of normal.
• 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.
• Those with a history of drug abuse or dependence within 6 months before randomization.
• Those who have used any Chinese and Western medicines to relieve cough and reduce phlegm within 24 hours before randomization.
• Pregnant and lactating female patients.
• Patients who have participated in or are participating in clinical trials of other drugs within 3 months prior to screening.
• Investigators deem others unsuitable to participate in this clinical trial.

Sponsors & Collaborators

• Guizhou Bailing Group Pharmaceutical Co Ltd: lead

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

MeSH Terms

Conditions

Cough; COVID-19

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Yun Ling

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 9, 2022
• Study Start: May 8, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)