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

NCT04291053 | Unknown Phase 2

• 1 other identifier: TJ-IRB20200205
• Study Type: interventional
• Target: 550
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Keywords

COVID-19; Huaier granule

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  All cause mortality

  up to 28 days

Secondary Outcomes (8)

• Clinical status assessed according to the official guideline

  up to 28 days

• The differences in oxygen intake methods

  up to 28 days

• Duration (days) of supplemental oxygenation

  up to 28 days

• Duration (days) of mechanical ventilation

  up to 28 days

• The mean PaO2/FiO2

  up to 28 days

Study Arms (2)

experimental group

EXPERIMENTAL

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

Drug: Huaier Granule

control group

NO INTERVENTION

standard therapy

Interventions

Huaier Granule DRUG

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

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years, extremes included, male or female
• 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)"
• patients can generally tolerable for treatment recommended by the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
• Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Female subjects who are pregnant or breastfeeding.
• patients who are allergic to this medicine
• patients meet the contraindications of Huaier granule
• Patients with diabetes
• Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
• patients can't take drugs orally

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Lin Chen

CONTACT

+8613517260864; chenlin_tj@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: April 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03