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

Phase 2

• Conditions: COVID-19
• Interventions: Drug: Huaier Granule

• Registration Number: NCT04291053
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Status Verified: 2020-03
• Study First Posted: 2020-03-02
• Last Update Submitted: 2020-03-14
• Last Update Posted: 2020-03-17
• Study Start: 2020-04-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Huaier Granule	Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)

Primary Outcome Measures

Name	Time	Method
Mortality rate	up to 28 days	All cause mortality

Secondary Outcome Measures

Name	Time	Method
Clinical status assessed according to the official guideline	up to 28 days	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
The differences in oxygen intake methods	up to 28 days	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,）.
Duration (days) of supplemental oxygenation	up to 28 days	days
Duration (days) of mechanical ventilation	up to 28 days	days
The mean PaO2/FiO2	up to 28 days
Length of hospital stay (days)	up to 28 days	days
Length of ICU stay (days)	up to 28 days	days
Pulmonary function	up to 3 months after discharge	forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge