A randomized, open-label, blank-controlled, multicenter trial for Shuang-Huang-Lian oral solution in the treatment of novel coronavirus pneumonia (COVID-19)

Not Applicable

Completed

• Conditions: ovel Coronavirus Pneumonia (COVID-19)

• Registration Number: ITMCTR2000003320
• Lead Sponsor: The First Affiliated Hospital of Wenzhou Medical University

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: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with confirmed new coronavirus-infected pneumonia;
2. Aged >=18 years old;
3. Voluntarily sign written informed consent.

Exclusion Criteria

1. Severe pneumonia requires mechanical ventilationcritically severe cases;
2. Estimated Time of Death is less than 48 hours;
3. There is clear evidence of bacterial infection in respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart disease,and abnormal lung development;
4. Chest CT confirmed that patients with basic pulmonary diseases such as severe pulmonary interstitial lesions and bronchiectasis;
5. In the opinion of the investigator, previous or present illnesses may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc.;
6. Mental state unable to cooperate, suffering from mental illness, unable to control, unable to express clearly
7. An allergic condition, such as a history of allergies to two or more drugs or foods, or a known allergy to the ingredients of the drug;
8. Patients with a history of substance abuse or dependence;
9. Pregnant or lactating women;
10. Patients who participated in other clinical trials within the last 3 months;
11. The investigator believes that there are any factors that are not suitable for enrollment or affect the evaluation of the efficacy.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Time to disease recovery;

Secondary Outcome Measures

Name	Time	Method
Biochemical Indicators;Time and rate of coronavirus become negative;Pathogen detection: respiratory and fecal viral loads;Exacerbation (transfer to RICU) time;Routine blood test;Clearance rate and time of main symptoms (fever, fatigue, cough);