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

NCT ID: NCT04291053

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-09-01

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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

Huaier Granule

Intervention Type DRUG

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

control group

standard therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Huaier Granule

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Xiaoping

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Lin Chen

Role: CONTACT

+8613517260864

Other Identifiers

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TJ-IRB20200205

Identifier Type: -

Identifier Source: org_study_id

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