Efficacy and safety evaluation of modified Yin Qiao San in the treatment of COVID-19 --A randomized, double-blind, placebo-controlled clinical trial

Phase 1

Recruiting

• Conditions: COVID-19

• Registration Number: ITMCTR2200006829
• Lead Sponsor: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Meet the diagnostic criteria of the Diagnosis and Treatment Program for Novel Coronavirus Pneumonia (Trial Ninth Edition);
2. Age 18-60 (including boundary value);
3. The subjects or their legal representatives signed the informed consent.

Exclusion Criteria

1. The subject has received antiviral treatment before entering the study, such as Paxlovid, ritonavir tablets, and SARS-CoV-2 monoclonal antibody treatment (except for the treatment of previous new crown infection);
2. Subjects have received convalescent plasma from convalescents and other clinical trial drugs with indications for new coronary pneumonia before entering the study (except for the treatment of previous new coronary infection);
3. Bacteria, fungi, viruses or other infections other than the new coronavirus are suspected during the screening period;
4. Need mechanical ventilation or expect to urgently need mechanical ventilation;
5. According to the investigator's judgment, the subject has a death crisis or death is inevitable in the next 24 hours, no matter what treatment is given;
6. Have used other experimental drugs 30 days before the baseline visit or within the five half-lives of the drug (the longer time is selected between the two) or during the planned study period;
7. Subjects participated in other clinical research within 30 days before the screening period;
8. Pregnant, lactating or lactating female subjects;
9. Allergic constitution or allergy to known research drugs;

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Proportion of clinical symptoms without progression within 10 days after treatment;

Secondary Outcome Measures

Name	Time	Method
Changes in the key symptoms of COVID-19 compared with the baseline on the 3rd, 5th, 7th, and 10th day after medication;Length of hospital stay;Proportion of transfers from square cabins to hospitals within 10 days;The time until the disappearance of clinical symptoms;negative conversion time of nucleic acid;