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

The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study

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 Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Huaier Granule

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)	Drug: Huaier Granule; standard treatment + Huaier Granule 20g po tid for 2weeks
No Intervention: control group; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	All cause mortality	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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,）.	up to 28 days
Duration (days) of supplemental oxygenation	days	up to 28 days
Duration (days) of mechanical ventilation	days	up to 28 days
The mean PaO2/FiO2		up to 28 days
Length of hospital stay (days)	days	up to 28 days
Length of ICU stay (days)	days	up to 28 days
Pulmonary function	forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge	up to 3 months after discharge

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Huaier granule
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: TJ-IRB20200205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No