Jinhua Qinggan Granules in the Treatment of COVID-19

Study Overview
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Brief Summary
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The clinical trial is designed to be randomized, double blind, placebo controlled, to evaluate the effectiveness and safety of Jinhua Qinggan granules (JHQG) on mild-category patients of COVID-19 in Pakistani population with the age limit of 18-75 years, at10th day comprehensive follow-up. The informed consent form must be signed by the subjects before their participation in the trial.

Detailed Description
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The course of treatment is 10 days, and the visit points are set on the 1st and 10th day, in which 10th day is follow-up. Patients will be assessed by using seven-category ordinal scale and clinical signs and symptoms on 1st and 10th day. If the subject recovers and checks out within 10 days, they will be recorded once before checking out. All effectiveness and safety inspection items will be done once before the trial and once at follow-up point i.e. 10th day. In case of any new abnormality or abnormality aggravation after the treatment, should be followed up until normal or stable.

Official Title
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Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial on the Effectiveness and Safety of Jinhua Qinggan Granules (JHQG) for the Treatment of COVID 19 Patients

Conditions
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COVID-19

Intervention / Treatment
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* Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Between the ages of 18-75 years, both male and female. 2) Confirmed Coronavirus infection by real time RT-PCR. 3) Mild cases of Coronavirus having main symptoms with minimum 2 grade (as mentioned in 7.1.6). 4) The subject has signed the informed consent form; Exclusion Criteria: 1) Younger than 18 years or older than 75 years. 2) Patients with moderate or critical Coronavirus infection confirmed by real time RT-PCR; cases meeting any of the following criteria: Lung lesions Respiratory failure and requiring mechanical ventilation Shock With other organ failure that requires ICU cares. 3) Severe primary health conditions associated with cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system (above grade II of cardiac function; ALT & AST are 1.5 times higher than the normal value; Creatinine above the upper limit of normal value) and mental illness or serious diseases affecting their survival, such as cancer or AIDS; 4) With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency. 5) Subjects, who took other antiviral, antibacterial, cough relieving, expectorant and antiasthmatic drugs within 3 days prior to the visit (including β2 receptor agonists, anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese Medicine.) 6) Allergic individuals and those who are known to be allergic to experimental drugs 7) Pregnant women, lactating women or fertile women who are ready to conceive in 3 months. 8) Subject, who has participated in the past 1 month in another clinical study. 9) Subjects who are not suitable for the clinical trial based on investigators' judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>150 Cases, treated with Jinhua Qinggan (JHQG) Granules | Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine<br>* Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.<br>|
| Placebo Comparator: Control group<br>150 Cases, Placebo treated | Other: Placebo Comparator<br>* Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Primary symptom (cough) | A grading symptom from 0-6 will be used to assess the symptom (Cough) where the score will be 0 for No cough, 2 for Intermittent cough, 4 for Cough mildly impacting the daily work and 6 Frequent cough or paroxysmal cough seriously impacting the work and life. | 10th day of treatment. | 
| Change in Primary symptom (Fever) | A grading symptom from 0-6 will be used to assess the improvement of main clinical symptom (Fever) where the score will be 0 for No fever ≤ 37 °C (98.6°F), 2 for body temperature > 37°C (98.6°F) to ≤ 38°C (100.4°F), 4 for body temperature > 38°C (100.4°F) to ≤ 39°C (102.2°F) and 6 for body temperature > 39°C (102.2°F) to ≤ 40°C (104°F). | 10th day of treatment | 
| Time for Negative COVID-19 Test | time for Negative coronavirus (COVID-19) Test on RT-PCR | 2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | The onset time of fever and the complete time of defervescence. | 10 days | 
| white blood cells count | Change in white blood cells count | during the 10-day course of treatment | 
| C-reactive protein test | Change in C-reactive protein level in blood | during the 10-day course of treatment | 
| ferritin test | Change in ferritin level in blood | during the 10-day course of treatment | 
| Radiology | Change in radiographic findings of the lungs. | during the 10-day course of treatment | 
| Quality of life assessment: | The quality of life of the product will be assessed by using the Patient's Quality of Life Assessment Questionnaire (QOL). The QOL questionnaire is divided into three parts: Psychology, Physiology, and Society. The score of each section is calculated by the sum of score of the part divided by the number of questions. The total is the sum of the three parts, and the minimum importance difference (MID) is 1.3, which means that if the QOL questionnaire score before and after treatment in the same patient rises by 1.3, it indicates that the treatment is effective. At the same time, the higher the QOL score, the lighter the illness is. | during the 10-day course of treatment |