The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19

Study Overview
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Brief Summary
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In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world.There is no specific drug treatment for this disease. This study is planned to observe the efficacy and safety of Huaier granule in the adjuvant treatment COVID-19.

Official Title
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The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Huaier Granule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 75 years, extremes included, male or female Patients diagnosed with mild or common type COVID-19, according to the official guideline Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6) patients can generally tolerable for treatment recommended by the official guideline Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6) Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Female subjects who are pregnant or breastfeeding. patients who are allergic to this medicine patients meet the contraindications of Huaier granule Patients with diabetes Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study. patients can't take drugs orally

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge) | Drug: Huaier Granule<br>* standard treatment + Huaier Granule 20g po tid for 2weeks<br>|
| No Intervention: control group<br>standard therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | All cause mortality | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status assessed according to the official guideline | 1.mild type：no No symptoms, Imaging examination showed no signs of pneumonia; 2,moderate type: with fever or respiratory symptoms,Imaging examination showed signs of pneumonia, SpO2>93% without oxygen inhalation ; severe type:Match any of the following：a. R≥30bpm；b.Pulse Oxygen Saturation(SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS | up to 28 days | 
| The differences in oxygen intake methods | Pulse Oxygen Saturation(SpO2)>93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）. | up to 28 days | 
| Duration (days) of supplemental oxygenation | days | up to 28 days | 
| Duration (days) of mechanical ventilation | days | up to 28 days | 
| The mean PaO2/FiO2 |  | up to 28 days | 
| Length of hospital stay (days) | days | up to 28 days | 
| Length of ICU stay (days) | days | up to 28 days | 
| Pulmonary function | forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge | up to 3 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Huaier granule