COVID-19 PneumoniaPhase 4NCT05366231

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

A Phase 4 study testing Kesuting syrup and LianHuaQingWen Granules in people with COVID-19 Pneumonia and Cough, run by Guizhou Bailing Group Pharmaceutical Co Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: COVID-19 Pneumonia, Cough
What is being tested?: Kesuting syrup and LianHuaQingWen Granules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteChina
Study dates: 8 May 2022to 15 Sep 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508

Other trials in China

About this study

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

Read the 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) .

Conditions: COVID-19 Pneumonia, Cough
Being tested: Kesuting syrup, LianHuaQingWen Granules
Keywords: Kesuting syrup, COVID-19
Medical subject headings: Cough, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kesuting syrupDrug
Also called Kesuting Tangjiang
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.
LianHuaQingWen GranulesDrug
Also called Lianhua Qingwen Keli
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.

Study groups in NCT05366231
Study group	Role	What they receive
Kesuting syrup group	Experimental	Kesuting syrup, the tested drug of this study. Receives: 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. Receives: Drug: LianHuaQingWen Granules

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: up to 14 days
Cough disappearance time
Change from Baseline，record the time in hour it takes for the cough to go away .
Measured: Baseline, at cough disappears up to 14 days

Secondary outcomes (8)

Disease recovery time
Evaluation of treatment endpoints
Measured: up to 14 days
Disease recovery rate
Evaluation of treatment endpoints
Measured: up to 14 days
The time of negative conversion of new coronavirus.
Record the time of negative conversion of new coronavirus.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline, 7 days of medication,up to 14 days
Incidence of severe/critical illness
Assess the incidence of severe/critical illness
Measured: up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202215 Sep 2022

First posted9 May 2022
Study start8 May 2022
Primary completion15 Sep 2022
Study completion15 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05366231
Sponsor's protocol ID: KST-22-01
Status last verified: Apr 2022
First submitted: 28 Apr 2022
Last updated: 19 Sep 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Positive Drug Parallel Controlled Clinical Trial of Kesuting Syrup in the Treatment of COVID-19 (Light)
ClinicalTrials.gov ID: NCT05366231
Acronym / sponsor ID: KST-22-01
Conditions: COVID-19 Pneumonia, Cough
Keywords: Kesuting syrup, COVID-19
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Guizhou Bailing Group Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
Study start: 8 May 2022 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: 15 Sep 2022 (actual)
First posted: 9 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Kesuting syrup group	Experimental	Drug: Kesuting syrupKesuting syrup, the tested drug of this study.
LianHuaQingWen Granules Control group	Active comparator	Drug: LianHuaQingWen GranulesLianHuaQingWen 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Kesuting syrupAlso: Kesuting TangjiangConventional 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.	Drug	Kesuting syrup group
LianHuaQingWen GranulesAlso: Lianhua Qingwen KeliConventional 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.	Drug	LianHuaQingWen Granules Control group

Primary outcome

Cough efficacy assessed by cough symptom scale（CSS）
Time frame: at baseline
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.
Cough efficacy by cough symptom scale（CSS）
Time frame: at 7 days of medication
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.
Cough efficacy by cough symptom scale（CSS）
Time frame: up to 14 days
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.
Cough disappearance time
Time frame: Baseline, at cough disappears up to 14 days
Change from Baseline，record the time in hour it takes for the cough to go away .

8 secondary outcomes

Disease recovery time
Time frame: up to 14 days
Disease recovery rate
Time frame: up to 14 days
The time of negative conversion of new coronavirus.
Time frame: at baseline, 7 days of medication, up to 14 days
The rate of negative conversion of new coronavirus.
Time frame: at baseline, 7 days of medication, up to 14 days
Efficacy of fever assessed by the single symptom grading standard formulated
Time frame: at baseline, 7 days of medication,up to 14 days
Efficacy of fatigue assessed by the single symptom grading standard formulated
Time frame: at baseline, 7 days of medication,up to 14 days
Efficacy of sore throat assessed by the single symptom grading standard formulated
Time frame: at baseline, 7 days of medication,up to 14 days
Incidence of severe/critical illness
Time frame: up to 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yun Ling principal investigator

Shanghai Public Health Clinical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Kesuting syrup and LianHuaQingWen Granules in people with COVID-19 Pneumonia and Cough, run by Guizhou Bailing Group Pharmaceutical Co Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cough efficacy assessed by cough symptom scale（CSS） (time frame: at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05366231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.