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

• ClinicalTrials.gov Identifier: NCT04295551
• Recruitment Status: Unknown
• First Posted: March 4, 2020
• Last Update Posted: March 4, 2020
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Information provided by (Responsible Party): Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection; Drug: Lopinavir/ritonavir treatment	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)
• Estimated Study Start Date: March 14, 2020
• Estimated Primary Completion Date: July 14, 2020
• Estimated Study Completion Date: April 14, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental group of ordinary COVID-19; Lopinavir / ritonavir tablets combined with Xiyanping injection	Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection; 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,
Active Comparator: Control group of ordinary COVID-19; ritonavir/ritonavir treatment	Drug: Lopinavir/ritonavir treatment; Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization
Experimental: Experimental group of severe COVID-19; Lopinavir / ritonavir tablets combined with Xiyanping injection	Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection; 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,

Outcome Measures

Primary Outcome Measures :

1. Clinical recovery time [ Time Frame: Up to Day 28 ]
   The time from study drug use to complete fever reduction and cough recovery is measured in hours.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia;
2. Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places;
3. Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors;
4. Women who are breastfeeding or pregnant;
5. Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies;
6. Those who have continued to use immunosuppressive agents or organ transplants in the past 6 months;
7. Patients who have participated in other drug clinical trials within 3 months before the screening test;
8. 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)

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04295551
• Other Study ID Numbers: QF-XYP1990-1
• First Posted: March 4, 2020
• Last Update Posted: March 4, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumonia; Coronavirus Infections; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Ritonavir; Lopinavir; HIV Protease Inhibitors; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors