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A multicenter, randomized, open, parallel controlled trial for the evaluation of the effectiveness and safety of Xiyanping injection in the treatment of common type novel coronavirus pneumonia (COVID-19)

A multicenter, randomized, open, parallel controlled trial for the evaluation of the effectiveness and safety of Xiyanping injection in the treatment of common type novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030117
Enrollment
Unknown
Registered
2020-02-23
Start date
2020-02-15
Completion date
Unknown
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Combination therapy group:Xiyanping injection+ conventional treatment
Conventional treatment group:Lopinavir / Ritonavir tablets, alpha-interferon

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old; 2. Meet the diagnostic criteria for confirmed cases in the diagnosis and treatment plan of new coronavirus-infected pneumonia (trial version 5); and the clinical symptoms before admission or screening must meet the following conditions: Fever (armpit temperature >=37.3 degree C, or mouth temperature >=38.0 degree C, or anal or ear temperature >=38.6 degree C) 24 beats / min or cough (at least one of the two); 3. Confirmed 2019-nCoV infection by Laboratory inspection (RT-PCR); 4. Have not previously received treatment or experimental treatment for COVID-19. Patients who have been treated with proprietary Chinese medicine or lopinavir / ritonavir tablets for less than 3 days can be enrolled; 5. Subjects volunteerly participate in this study and agree to sign informed consent; 6. According to the researcher's judgment, the subject / legal guardian is considered reliable and able to comply with this plan, visit plan and medication arrangement.

Exclusion criteria

Exclusion criteria: 1. Allergic constitution (persons who are allergic to more than 2 kinds of substances), people who are allergic to similar drugs in the past or those who are known to be allergic to the ingredients and auxiliary materials in the test drugs; 2. Patients who have participated in other clinical trials in the past 3 months; 3. Patients not suitable for the clinical trials judged by researchers.

Design outcomes

Primary

MeasureTime frame
Clinical recovery time;

Secondary

MeasureTime frame
fever;

Countries

China

Contacts

Public ContactHongzhou Lu

Jiangxi Qingfeng Pharmaceutical Co., Ltd.

luhongzhou@shphc.org.cn+86 21-37990333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026