Clinical trial NCT04955223: Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
Official title: Non-random Single-arm Clinical Study of Yinhu Qingwen Granule in the Treatment of Viral Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Viral Pneumonia
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a non-randomized single arm clinical study to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.

Detailed description: Preliminary pharmacodynamic and toxicological studies can show that Yinhu Qingwen Granule has a certain effect on pneumonia caused by various viruses, and its safety is good. This study aims to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of viral pneumonia;
* Clinical diagnosis of Shi-du-yun-jie Zheng (damp stagnation syndrome) according to Chinese medicine, including fever,cough,sore throat,stuffy chest,irritability and thirst,short yellow urine,constipation or loose stool,thick and greasy yellow coating,and slippery pulse;
* Chest CT showed signs of acute exudative pneumonia in the lungs;
* Over 18 years old, regardless of gender, voluntarily signed an informed consent form;
* Those who were hospitalized and were accompanied by fever (body temperature ≥37.3℃) and respiratory tract symptoms like cough or dyspnea, when they were enrolled.

Exclusion Criteria:

* Patients that are susceptible to sensitivity or known to be allergic to the study drug;
* Patients whose white blood cell count ≥12×10\^9 or neutrophil percentage ≥80%;
* Patients whose weight is less than 40 kg;
* Patients with respiratory failure or need mechanical ventilation;
* Patients with shock;
* Patients required to be in ICU monitoring and treatment;
* Patients participated in other clinical trials within 1 month;
* Patients with known renal impairment;
* Patients with any of the following laboratory parameter abnormalities during the screening period or within 24 hours before screening: ALT or AST level\> 5 times the upper limit of normal range (ULN) or-ALT or AST level \> 3 times ULN and total bilirubin level\> 2 times ULN;
* Patients with immune system diseases and long-term use of immunosuppressive agents;
* Pregnant or breastfeeding women, or who have a positive pregnancy test during the screening period, or plan to become pregnant within 3 months after the study treatment.

Primary outcomes:
measure: Time to the normalization of the temperature
timeFrame: up to 30 days
Secondary outcomes:
measure: Time to cough reported as mild or absent
timeFrame: Baseline, Day 3, Day 7, Day 10 and Day 30
measure: Mean clinical recovery time (hours)
timeFrame: up to 30 days
measure: Time to dyspnea reported as mild or absent
timeFrame: Baseline, Day 3, Day 7, Day 10 and Day 30
measure: Mean blood oxygen saturation
timeFrame: Baseline, Day 3, Day 7, Day 10
measure: Mean neutrophil/lymphocyte ratio (NLR)
timeFrame: Baseline, Day 10
measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation
timeFrame: up to 30 days
measure: Mean time of supplemental oxygen (days)
timeFrame: up to 30 days
measure: Mean time of non-invasive ventilation (days)
timeFrame: up to 30 days
measure: Severe case incidence
timeFrame: up to 30 days
measure: Proportion of re-hospitalization or admission to ICU
timeFrame: up to 30 days
measure: All-cause mortality
timeFrame: up to 30 days
measure: Frequency of serious adverse events
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Chengdu
country: China
facility: Chengdu First People's Hospital/Chengdu integrated TCM & Western Medicine Hospital
state: Sichuan
Study officials:
References: