Clinical trial NCT05366231: Kesuting Syrup in the Treatment of Corona Virus Disease 2019 (COVID-19)
Official title: A Randomized, Open-label, Positive Drug Parallel Controlled Clinical Trial of Kesuting Syrup in the Treatment of COVID-19 (Light)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19 Pneumonia
Cough
Keywords: Kesuting syrup
COVID-19
Lead sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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) .

Eligibility criteria: 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.

Primary outcomes:
measure: Cough efficacy assessed by cough symptom scale（CSS）
timeFrame: at baseline
measure: Cough efficacy by cough symptom scale（CSS）
timeFrame: at 7 days of medication
measure: Cough efficacy by cough symptom scale（CSS）
timeFrame: up to 14 days
measure: Cough disappearance time
timeFrame: Baseline, at cough disappears up to 14 days
Secondary outcomes:
measure: Disease recovery time
timeFrame: up to 14 days
measure: Disease recovery rate
timeFrame: up to 14 days
measure: The time of negative conversion of new coronavirus.
timeFrame: at baseline, 7 days of medication, up to 14 days
measure: The rate of negative conversion of new coronavirus.
timeFrame: at baseline, 7 days of medication, up to 14 days
measure: Efficacy of fever assessed by the single symptom grading standard formulated
timeFrame: at baseline, 7 days of medication,up to 14 days
measure: Efficacy of fatigue assessed by the single symptom grading standard formulated
timeFrame: at baseline, 7 days of medication,up to 14 days
measure: Efficacy of sore throat assessed by the single symptom grading standard formulated
timeFrame: at baseline, 7 days of medication,up to 14 days
measure: Incidence of severe/critical illness
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Yun Ling
role: PRINCIPAL_INVESTIGATOR
References: