To evaluate the clinical mechanism of Lianhua Qingwen Capsule on the systemic immune regulation of patients with new coronavirus pneumonia

Phase 4

Recruiting

• Conditions: Coronavirus diseaseNovel Coronavirus Pneumonia (COVID-19)

• Registration Number: ITMCTR2100004767
• Lead Sponsor: Shanghai Public Health Clinical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18 to 59 years;
2. Refer to the New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Eighth Edition) formulated by the National Health Commission, with evidence of etiology or serology, and confirmed mild patients with new coronavirus pneumonia (mild clinical symptoms, no imaging Pneumonia manifestations).
3. The weight of male subjects must be >=50 kg, and the weight of female subjects >=45kg; body mass index (BMI=weight (kg)/height (m) square calculation) between 19 and 26 (including cutoff values));
4. The subject understands and accepts the process and restriction requirements of this study, voluntarily participates in this clinical study, and signs a written informed consent form.

Exclusion Criteria

1. Patients who have taken Xiyanping, Reduning, Tanreqing, Jinhua Qinggan, Banlangen and other antiviral Chinese medicines and/or immunomodulators, or drugs with immunomodulatory effects for external use within 1 week before being selected;
2. Currently suffering from diseases that seriously affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc.
3. According to the judgment of the investigator, past or current diseases may affect the patients participation in the trial or the outcome of the study, including: malignant diseases, autoimmune diseases, liver and kidney diseases, hematological diseases, neurological diseases, and endocrine diseases Disease; or mental illness that may affect the compliance of the plan;
4. Patients who have a history of alcohol or banned drug abuse, or have taken or used alcohol products during the research period;
5. Serological examination (HBsAg, anti-HCV, anti-HIV or TPPA-Ab) with positive results;
6. Patients who have a history of drug dependence or drug abuse within 12 months, or those who tested positive for addictive substances during screening;
7. Patients with known allergies to Lianhua Qingwen ingredients or products, or allergies (including allergic reactions to other drugs);
8. Patients who have other factors that the researcher thinks are not suitable for participating in this research.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory factors;Immune cell genus;