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

Tongji Hospital550 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

550

Conditions

COVID-19

Interventions

Huaier GranuleDRUG

standard treatment + Huaier Granule 20g po tid for 2weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 75 years, extremes included, male or female 2. 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)" 3. patients can generally tolerable for treatment recommended by the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)" 4. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1 5. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding. 2. patients who are allergic to this medicine 3. patients meet the contraindications of Huaier granule 4. Patients with diabetes 5. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study. 6. patients can't take drugs orally

Outcomes

Primary Outcomes

Mortality rate

All cause mortality

Time frame: up to 28 days

Secondary Outcomes

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

Time frame: 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,）.

Time frame: up to 28 days

Duration (days) of supplemental oxygenation

days

Time frame: up to 28 days

Duration (days) of mechanical ventilation

days

Time frame: up to 28 days

The mean PaO2/FiO2

Time frame: up to 28 days

Length of hospital stay (days)

Central Contacts

Lin Chen

CONTACT

+8613517260864 chenlin_tj@126.com

Data from ClinicalTrials.gov

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