RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19

Study Overview
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Brief Summary
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This is a randomized, double-blinded, placebo-controlled clinical trial. This study is to evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the major symptoms of mild and moderate COVID-19 patients by telemedicine.

Detailed Description
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Subjects who are diagnosed with COVID-19 by RATs or PCR tests and fulfilled the eligibility criteria will receive a maximum of 14 days of treatment with Yinqiaosan-Maxingganshitang (with or without specified additions) or placebo and will be followed up on day 7, 14 and 35 after receiving medication (day 0).

Official Title
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Assessing the Efficacy and Safety of Yinqiaosan-Maxingganshitang in the Treatment of the Major Symptoms of Mild and Moderate COVID-19 by Telemedicine - a Randomized, Double-blind, Placebo-controlled Trial

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Chinese Herb
* Diagnostic Test: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 65 years; Tested positive for COVID-19 by RATs, Deep Throat Saliva (DTS) or Throat/Nasal swab RT-PCR tests; Patient diagnosed with mild to moderate COVID-19 based on the Coronavirus disease 2019 (COVID-19) Treatment Guidelines published by National Institutes of Health; Duration of symptoms ≤ 72 hours (Start from the presence of the major symptoms of COVID-19: Fever: oral temperature >37.2°C, or cough score ≥2, or fatigue score ≥2); Diagnosed with pattern of wind and heat invading the surface and/or pattern of intense exuberance of lung heat by a registered Chinese medicine practitioner (CMP) (Diagnostic criteria are the corresponding criteria in the Diagnosis standards for common syndromes in traditional Chinese medicine) published by Diagnostic Subcommittee of China Association of Traditional Chinese Medicine in 2008, with ≥20 as the threshold for determination); Explicit declaration of willingness to participate in the study at the time of videoconference screening after reading the electronic informed consent form (written consent form have to signed after inclusion). Exclusion Criteria: Diagnosed of Asymptomatic or Presymptomatic Infection, Severe Illness or Critical Illness of COVID-19 based on the Coronavirus disease 2019 (COVID-19) Treatment Guidelines published by National Institutes of Health Known allergy to the Chinese medicines or other ingredients of the investigational medicinal products (IMP) used in this study; Known pregnancy or lactation; Known immunocompromised patient (such as malignancy, organ or bone marrow transplant, AIDS or low immune function caused by long-term use of corticosteroids or other immunosuppressants) Known obesity (Body Mass Index [BMI] ≥30) Heavy smoker (≥400 cigarettes/year) Known history of cardiovascular and cerebrovascular diseases (including hypertension), chronic lung disease (chronic obstructive pulmonary disease, moderate and severe asthma or interstitial lung disease), diabetes, chronic liver disease (ALT/AST ≥ 2× the upper limit of normal [ULN], Bilirubin-Total ≥ 1.5ULN), chronic kidney disease (Creatinine ≥1.5ULN), cancer or other chronic diseases. Known history of dysphagia or any gastrointestinal disorder that affects drug absorption (such as gastroesophageal reflux disease [GERD], chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, gastrectomy); Suspected or known history of alcohol or substance abuse or mental illness; Subjects having participated in other clinical studies in the past three months; Any other condition that in the opinion of the investigators could compromise the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment (Yinqiaosan-Maxingganshitang )<br>Chinese Medicine granules | Drug: Chinese Herb<br>* Yinqiaosan-Maxingganshitang granules<br>* Other names: CM;|
| Placebo Comparator: Placebo<br>Placebo granules | Diagnostic Test: Placebo<br>* Placebo<br>* Other names: Plavebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for the body temperature to change to normal | The time between starting medication and body temperature dropping to normal (oral temperature ≤ 37.2℃ and maintain 24 hours). | From baseline to week 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of negative Rapid Antigen Test | 2. The negative rate of Rapid Antigen Tests (RATs) at day 14 and the negative conversion time (two successive negative RATs result with at least 24 hours interval) | From baseline to reaching outcome | 
| Remission rate of cough | The remission of cough will be measured by the score rating from 0 to 4, which representing None, Mild, Moderate, Severe and Very severe respectively. The score of 1 or below and maintain for 24 hours will be counted as remission. | 14 days | 
| Remission rate of fatigue | The remission of fatigue will be measured by the score rating from 0 to 4, which representing None, Mild, Moderate, Severe and Very severe respectively. The score of 1 or below and maintain for 24 hours will be counted as remission. | 14 days | 
| Time of remission of cough | Time from the start of treatment to the symptom remission | From baseline to week 19 | 
| Time of remission of fatigue | Time from the start of treatment to the symptom remission | From baseline to week 19 | 
| Disappearance rate of COVID symptom | The disappearance rate of the COVID symptom | 14 days | 
| Incidence to severe illness | Incidence of the progression to severe ot critical illness during the trial | From baseline to 19 weeks | 
| Mortality | All-cause mortality at the 21th days after stopping the medications | 21 days | 
| Utilization rate of rescue drugs | Utilization rate of antipyretic, Paxlovid and molnupiravir within 14 days | 14 days | 
| Dosage of rescue drugs | Dosage of antipyretic, Paxlovid and molnupiravir within 14 days | 14 days |