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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04291053
• Other study ID #: TJ-IRB20200205
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: Lin Chen
• Phone: +8613517260864
• Email: chenlin_tj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	All cause mortality	up to 28 days
Secondary	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
Secondary	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
Secondary	Duration (days) of supplemental oxygenation	days	up to 28 days
Secondary	Duration (days) of mechanical ventilation	days	up to 28 days
Secondary	The mean PaO2/FiO2		up to 28 days
Secondary	Length of hospital stay (days)	days	up to 28 days
Secondary	Length of ICU stay (days)	days	up to 28 days
Secondary	Pulmonary function	forced expiratory volume at one second ,maximum voluntary ventilation at 1month,2month,3month after discharge	up to 3 months after discharge