A single center, retrospective, randomized controlled trial of Pu Ping Qing Hua Fang vs Lian Hua Qing Wen in shortening the time of turning negative in novel coronavirus positive patients

Not Applicable

Recruiting

• Conditions: 2019 Novel Coronavirus Pneumonia (COVID-19) Positive Patients

• Registration Number: ITMCTR2200006048
• Lead Sponsor: Shanghai Jiaotong University School of Medicine, Renji Hospital

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) Sign written informed consent before any study specific operation or treatment, aged 18-90 years, regardless of gender;
2) The patient was infected with novel coronavirus and confirmed by rtPCR;
3) The Eastern Cooperative Oncology Group (ECOG) performance score was 0 or 1.
4) After screening and examination, it is determined that it has sufficient baseline organ function and hematological function.
5) Must agree and comply with the visit plan of the study and other requirements specified in the protocol, including telephone follow-up.

Exclusion Criteria

1) Pregnant or lactating women with ECOG score greater = grade 2;
2) There is untreated tumor central nervous system (CNS) metastasis. If the imaging examination shows that there is no new metastasis or metastasis progression after at least 4 weeks after the treatment of CNS metastasis, the subject fluid is allowed to be included in this study. CNS imaging examination during screening is not necessary, but only for people with clinical indications.
3) Patients who had undergone major surgery within 28 days before randomization in this study.
4) Uncontrolled active bleeding or bleeding tendency.
5) Clinically significant gastrointestinal abnormalities that may affect the absorption of the study drug or even increase the risk of bleeding or perforation, including any previous history of gastrointestinal perforation.
6) Other malignant tumors requiring treatment in the past 3 years.
7) Poorly controlled hypertension is defined as systolic blood pressure = 160 or diastolic blood pressure = 100 mmHg. Allow the use of antihypertensive drugs and rescreening.
8) Any one or more of the following medical history within 6 months before randomization: symptomatic peripheral vascular disease; Coronary artery bypass grafting; Myocardial infarction or unstable angina pectoris; Cardiac angioplasty or stent implantation; Cerebrovascular accidents, including transient ischemic attack.
9) New York Heart Association class III or IV congestive heart failure.
10) There are uncontrolled concurrent diseases, and these factors will affect the subjects' compliance with the relevant requirements of this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
ucleic acid negative conversion time and negative conversion rate;