NCT04275388

Brief Summary

the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
Last Updated

May 20, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

February 17, 2020

Last Update Submit

May 17, 2020

Conditions

2019 Novel Coronavirus Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Clinical recovery time

    From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours

    Up to Day 14

Secondary Outcomes (4)

  • Complete fever time

    Up to Day 14

  • Cough relief time

    Up to Day 14

  • Virus negative time

    Up to Day 14

  • Incidence of severe or critical neocoronavirus pneumonia

    Up to Day 14

Study Arms (2)

Xiyanping injection +other drugs

Drug: Xiyanping injection Xiyanping injection: 10-20ml daily, Qd, the maximum daily dose does not exceed 500mg (20mL) Other drugs: Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride

Drug: Xiyanping injectionDrug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

other drugs

Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride

Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride

Interventions

Xiyanping injectionDRUG

Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet /Ritonavir tablet or Alpha-interferon nebulization or Abidor Hydrochloride,

Xiyanping injection +other drugs
Lopinavir / ritonavir, alpha-interferon nebulization,Abidor HydrochlorideDRUG

Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization;Abidor Hydrochloride

Xiyanping injection +other drugsother drugs

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with new coronary pneumonia

You may qualify if:

  • Laboratory examination (RT-PCR) confirms the infection 2019-nCoV, which meets the diagnostic criteria for pneumonia (common type) in the New Coronavirus Infection Pneumonia Diagnosis and Treatment Program (Trial Version 6);
  • The patient has a complete hospitalization record that can be used for research.

You may not qualify if:

  • Subjects who meet any of the following criteria cannot be enrolled:
  • Suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;
  • People with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors;
  • According to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc;
  • Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;
  • Used Chinese patent medicines with similar efficacy as Xiyanping injection during the treatment.
  • The investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

routine blood test

MeSH Terms

Interventions

LopinavirRitonavir

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Central Study Contacts

Hongzhou Lu, Master

CONTACT

021-37990333lunliweiyuanhui2009@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

May 15, 2020

Primary Completion

July 14, 2020

Study Completion

December 14, 2021

Last Updated

May 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share