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

Tongji Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Huaier Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT04291053

TJ-IRB20200205

Details and patient eligibility

About

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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

experimental group

Experimental group

Description:

Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)

Treatment:

Drug: Huaier Granule

control group

No Intervention group

Description:

standard therapy