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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04291053
Recruitment Status : Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Chen Xiaoping, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Huaier Granule Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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



Primary Outcome Measures :
  1. Mortality rate [ Time Frame: up to 28 days ]
    All cause mortality


Secondary Outcome Measures :
  1. 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

  2. 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,).

  3. Duration (days) of supplemental oxygenation [ Time Frame: up to 28 days ]
    days

  4. Duration (days) of mechanical ventilation [ Time Frame: up to 28 days ]
    days

  5. The mean PaO2/FiO2 [ Time Frame: up to 28 days ]
  6. Length of hospital stay (days) [ Time Frame: up to 28 days ]
    days

  7. Length of ICU stay (days) [ Time Frame: up to 28 days ]
    days

  8. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lin Chen +8613517260864 chenlin_tj@126.com

Sponsors and Collaborators
Tongji Hospital
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Responsible Party: Chen Xiaoping, Principal Investigator, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04291053    
Other Study ID Numbers: TJ-IRB20200205
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chen Xiaoping, Tongji Hospital:
COVID-19
Huaier granule