NCT04291053
Unknown
Phase 2
The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study
Overview
- Phase
- Phase 2
- Intervention
- Huaier Granule
- Conditions
- COVID-19
- Sponsor
- Tongji Hospital
- Enrollment
- 550
- Primary Endpoint
- Mortality rate
- Last Updated
- 6 years ago
Overview
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.
Investigators
Chen Xiaoping
Principal Investigator
Tongji Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
experimental group
Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)
Intervention: Huaier Granule
Outcomes
Primary Outcomes
Mortality rate
Time Frame: up to 28 days
All cause mortality
Secondary Outcomes
- Duration (days) of mechanical ventilation(up to 28 days)
- The mean PaO2/FiO2(up to 28 days)
- Length of hospital stay (days)(up to 28 days)
- Length of ICU stay (days)(up to 28 days)
- Pulmonary function(up to 3 months after discharge)
- 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)
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