The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19
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|ClinicalTrials.gov Identifier: NCT04291053|
Recruitment Status : Unknown
Verified March 2020 by Chen Xiaoping, Tongji Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : March 17, 2020
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Huaier Granule||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
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
- Mortality rate [ Time Frame: up to 28 days ]All cause mortality
- Clinical status assessed according to the official guideline [ Time Frame: up to 28 days ]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
- The differences in oxygen intake methods [ Time Frame: up to 28 days ]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,）.
- Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]days
- Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]days
- The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
- Length of hospital stay (days) [ Time Frame: up to 28 days ]days
- Length of ICU stay (days) [ Time Frame: up to 28 days ]days
- Pulmonary function [ Time Frame: up to 3 months after discharge ]forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291053
|Contact: Lin Chenemail@example.com|
|Responsible Party:||Chen Xiaoping, Principal Investigator, Tongji Hospital|
|Other Study ID Numbers:||
|First Posted:||March 2, 2020 Key Record Dates|
|Last Update Posted:||March 17, 2020|
|Last Verified:||March 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases