Clinical trial NCT04645407: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Novel Coronavirus Pneumonia
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
Collaborators: name: Hubei Hospital of Traditional Chinese Medicine
name: Jingmen No.1 People's Hospital
First posted: 2020-11-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the percentage of patients showing improvement in chest CT
timeFrame: Week 2
Secondary outcomes:
measure: remission rate or progression rate of critical illness
timeFrame: Week 2
measure: clinical remission rate of respiratory symptoms
timeFrame: week 2
measure: routine blood examination
timeFrame: Week 2
measure: C-reactive protein level
timeFrame: Week 2
measure: procalcitonin level
timeFrame: Week 2
measure: oxygen saturation
timeFrame: Week 2
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital
state: Shanghai
Study officials:
References: