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Effects of Fuzheng Huayu Tablets on COVID-19

Primary Purpose

Novel Coronavirus Pneumonia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fuzheng Huayu tablet
Sponsored by
ShuGuang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Novel Coronavirus Pneumonia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients were included if they (1) had COVID-19; (2) were 18 to 65 years old; (3) did not participate in other drug clinical studies within 1 month before enrollment; and (4) voluntarily accepted treatment and signed an informed consent form.

Exclusion Criteria:

Patients were excluded if they (1) had critical COVID-19; (2) were unconsciousness, had dementia, had psychiatric conditions, or were unable to communicate normally; (3) had severe cardiac insufficiency (i.e., cardiac function grade IV), severe liver or kidney disease, bronchial asthma, COPD, neurological disease, tumor, thoracic deformity, or immunodeficiency disease; (4) were pregnant or lactating or had a recent pregnancy plan; and (5) had a known allergy to any treatment drug.

Sites / Locations

  • Shuguang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FZHY Group

Control Group

Arm Description

conventional therapy plus Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time.)

conventional therapy

Outcomes

Primary Outcome Measures

the percentage of patients showing improvement in chest CT
Evaluation of the therapeutic effect of Fuzheng huayu tablet

Secondary Outcome Measures

remission rate or progression rate of critical illness
Evaluation of pulmonary inflammation improvement
clinical remission rate of respiratory symptoms
Evaluation of pulmonary inflammation improvement
routine blood examination
Evaluation of pulmonary inflammation improvement
C-reactive protein level
Evaluation of the therapeutic effect of Fuzheng huayu tablet
procalcitonin level
Evaluation of pulmonary inflammation improvement
oxygen saturation
Evaluation of pulmonary inflammation improvement

Full Information

First Posted
February 15, 2020
Last Updated
November 25, 2020
Sponsor
ShuGuang Hospital
Collaborators
Hubei Hospital of Traditional Chinese Medicine, Jingmen No.1 People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04645407
Brief Title
Effects of Fuzheng Huayu Tablets on COVID-19
Official Title
Efficacy of Fuzheng Huayu Tablets for Treating Pulmonary Inflammation in Patients With COVID-19: A Case-Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital
Collaborators
Hubei Hospital of Traditional Chinese Medicine, Jingmen No.1 People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The 2019 novel coronavirus (2019-nCoV) infection caused clusters of severe respiratory illness similar to SARS and was associated with ICU admission and high mortality. There is no confirmed antivirus therapy for people infected 2019-nCoV, most of them should receive supportive care to help relieve symptoms. This clinical trial is to evaluate the effect of Fuzheng Huayu tablet on lung inflammation in intensive patients with novel coronavirus pneumonia and reduce the progressive rate to critical type.
Detailed Description
In December 2019, new coronavirus pneumonia (NCP) occurred in Wuhan, Hubei Province, which spread rapidly. Some of the patients developed into severe or critical illness. It became an international concerned public health emergencies and one of the major epidemics seriously endangering people's health and public safety after severe acute respiratory syndrome (SARS) in 2003. At present, we lack the specific treatment for NCP. The anti- novel coronavirus drugs are been conducting in clinical trials, and the other options includes the symptomatic treatment. The pathological mechanism of the disease is not clear, but due to the continuous development of inflammation, some cases can become severe or critical, which threatening the life and health of patients. Intensive cases with obvious inflammation, after the control of acute symptoms and signs, often have the performance of pulmonary fibrosis, affecting the recovery of lung function. Therefore, actively reducing lung inflammation, controlling and reversing pulmonary fibrosis is of great significance for the life and health of patients Infected novel coronavirus. Our previous study found that Fuzheng Huayu prescription can reduce the inflammation and fibrosis of the lung in the model rats, and improve the lung function of the patients with COPD. Therefore, we hope to take Fuzheng Huayu tablet to NCP patients, and observe whether it can reduce the lung inflammation of patients, so as to reduce the rate of progression of critical illness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Novel Coronavirus Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FZHY Group
Arm Type
Experimental
Arm Description
conventional therapy plus Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time.)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
conventional therapy
Intervention Type
Drug
Intervention Name(s)
Fuzheng Huayu tablet
Intervention Description
Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time)
Primary Outcome Measure Information:
Title
the percentage of patients showing improvement in chest CT
Description
Evaluation of the therapeutic effect of Fuzheng huayu tablet
Time Frame
Week 2
Secondary Outcome Measure Information:
Title
remission rate or progression rate of critical illness
Description
Evaluation of pulmonary inflammation improvement
Time Frame
Week 2
Title
clinical remission rate of respiratory symptoms
Description
Evaluation of pulmonary inflammation improvement
Time Frame
week 2
Title
routine blood examination
Description
Evaluation of pulmonary inflammation improvement
Time Frame
Week 2
Title
C-reactive protein level
Description
Evaluation of the therapeutic effect of Fuzheng huayu tablet
Time Frame
Week 2
Title
procalcitonin level
Description
Evaluation of pulmonary inflammation improvement
Time Frame
Week 2
Title
oxygen saturation
Description
Evaluation of pulmonary inflammation improvement
Time Frame
Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were included if they (1) had COVID-19; (2) were 18 to 65 years old; (3) did not participate in other drug clinical studies within 1 month before enrollment; and (4) voluntarily accepted treatment and signed an informed consent form. Exclusion Criteria: Patients were excluded if they (1) had critical COVID-19; (2) were unconsciousness, had dementia, had psychiatric conditions, or were unable to communicate normally; (3) had severe cardiac insufficiency (i.e., cardiac function grade IV), severe liver or kidney disease, bronchial asthma, COPD, neurological disease, tumor, thoracic deformity, or immunodeficiency disease; (4) were pregnant or lactating or had a recent pregnancy plan; and (5) had a known allergy to any treatment drug.
Facility Information:
Facility Name
Shuguang Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China

12. IPD Sharing Statement

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Effects of Fuzheng Huayu Tablets on COVID-19

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