Effects of Fuzheng Huayu Tablets on COVID-19

Novel Coronavirus Pneumonia Clinical Trial

Official title:

Efficacy of Fuzheng Huayu Tablets for Treating Pulmonary Inflammation in Patients With COVID-19: A Case-Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645407
• Other study ID #: Fzhy-ncp-1
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: April 15, 2020

Study information

• Verified date: November 2020
• Source: ShuGuang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Novel Coronavirus Pneumonia
• Pneumonia

Intervention

Drug:
• Fuzheng Huayu tablet
Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time)

Locations

Country	Name	City	State
China	Shuguang Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
ShuGuang Hospital	Hubei Hospital of Traditional Chinese Medicine, Jingmen No.1 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients showing improvement in chest CT	Evaluation of the therapeutic effect of Fuzheng huayu tablet	Week 2
Secondary	remission rate or progression rate of critical illness	Evaluation of pulmonary inflammation improvement	Week 2
Secondary	clinical remission rate of respiratory symptoms	Evaluation of pulmonary inflammation improvement	week 2
Secondary	routine blood examination	Evaluation of pulmonary inflammation improvement	Week 2
Secondary	C-reactive protein level	Evaluation of the therapeutic effect of Fuzheng huayu tablet	Week 2
Secondary	procalcitonin level	Evaluation of pulmonary inflammation improvement	Week 2
Secondary	oxygen saturation	Evaluation of pulmonary inflammation improvement	Week 2