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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge) |
|
| control group | No Intervention | standard therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaier Granule | Drug | standard treatment + Huaier Granule 20g po tid for 2weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | All cause mortality | up to 28 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Chen | Contact | +8613517260864 | chenlin_tj@126.com |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |