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

NCT04295551 | Unknown

• 1 other identifier: QF-XYP1990-1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical recovery time

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

  Up to Day 28

Study Arms (3)

Experimental group of ordinary COVID-19

EXPERIMENTAL

Lopinavir / ritonavir tablets combined with Xiyanping injection

Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection

Control group of ordinary COVID-19

ACTIVE COMPARATOR

ritonavir/ritonavir treatment

Drug: Lopinavir/ritonavir treatment

Experimental group of severe COVID-19

EXPERIMENTAL

Lopinavir / ritonavir tablets combined with Xiyanping injection

Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection

Interventions

Lopinavir / ritonavir tablets combined with Xiyanping injection DRUG

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,

Experimental group of ordinary COVID-19; Experimental group of severe COVID-19

Lopinavir/ritonavir treatment DRUG

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

Control group of ordinary COVID-19

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

MeSH Terms

Conditions

COVID-19

Interventions

Lopinavir; Ritonavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 4, 2020
• Study Start: March 14, 2020
• Primary Completion: July 14, 2020
• Study Completion: April 14, 2021
• Last Updated: March 4, 2020

Record last verified: 2020-03