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Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

Primary Purpose

COVID-19

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Lopinavir / ritonavir tablets combined with Xiyanping injection

Lopinavir/ritonavir treatment

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged >=18 years;
Novel coronavirus pneumonia patients diagnosed by pathogenic testing;
The patient himself participated in the study voluntarily, agreed and signed the informed consent.

Exclusion Criteria:

Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia;
Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places;
Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors;
Women who are breastfeeding or pregnant;
Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies;
Those who have continued to use immunosuppressive agents or organ transplants in the past 6 months;
Patients who have participated in other drug clinical trials within 3 months before the screening test;
The investigator judges that he or she cannot complete or should not participate in the study (expected death within 48 hours, and the patient refuses active treatment)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Experimental group of ordinary COVID-19

Control group of ordinary COVID-19

Experimental group of severe COVID-19

Arm Description

Lopinavir / ritonavir tablets combined with Xiyanping injection

ritonavir/ritonavir treatment

Lopinavir / ritonavir tablets combined with Xiyanping injection

Outcomes

Primary Outcome Measures

Clinical recovery time

The time from study drug use to complete fever reduction and cough recovery is measured in hours.

Secondary Outcome Measures

Full Information

NCT ID

NCT04295551

First Posted

March 3, 2020

Last Updated

March 3, 2020

Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04295551

Brief Title

Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

Official Title

Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 14, 2020 (Anticipated)

Primary Completion Date

July 14, 2020 (Anticipated)

Study Completion Date

April 14, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.

Detailed Description

The new coronavirus (COVID-19) [1] belongs to the new beta coronavirus. Current research shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV. Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. With the spread of the epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide (Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei Province), and a mortality rate of 2.49% (3.20% in Hubei Province). In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. In the early clinical practice of treating severe H1N1, it was clinically concerned, and combined with conventional treatment, and achieved good results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group of ordinary COVID-19

Arm Type

Experimental

Arm Description

Lopinavir / ritonavir tablets combined with Xiyanping injection

Arm Title

Control group of ordinary COVID-19

Arm Type

Active Comparator

Arm Description

ritonavir/ritonavir treatment

Arm Title

Experimental group of severe COVID-19

Arm Type

Experimental

Arm Description

Lopinavir / ritonavir tablets combined with Xiyanping injection

Intervention Type

Drug

Intervention Name(s)

Lopinavir / ritonavir tablets combined with Xiyanping injection

Intervention Description

Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet or Ritonavir tablet+Alpha-interferon nebulization, for 7-14 days,

Intervention Type

Drug

Intervention Name(s)

Lopinavir/ritonavir treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical recovery time

Description

The time from study drug use to complete fever reduction and cough recovery is measured in hours.

Time Frame

Up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged >=18 years; Novel coronavirus pneumonia patients diagnosed by pathogenic testing; The patient himself participated in the study voluntarily, agreed and signed the informed consent. Exclusion Criteria: Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia; Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places; Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors; Women who are breastfeeding or pregnant; Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies; Those who have continued to use immunosuppressive agents or organ transplants in the past 6 months; Patients who have participated in other drug clinical trials within 3 months before the screening test; The investigator judges that he or she cannot complete or should not participate in the study (expected death within 48 hours, and the patient refuses active treatment)

12. IPD Sharing Statement

Learn more about this trial

Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

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