Status unknownNCT04295551Updated Mar 4, 2020

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

An interventional study of Lopinavir / ritonavir tablets combined with Xiyanping injection and Lopinavir/ritonavir treatment in COVID-19, sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd.. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

COVID-19

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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 80 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

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Lead sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd. is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 80 participants (estimated)

Study arms

Experimental
Experimental group of ordinary COVID-19
Lopinavir / ritonavir tablets combined with Xiyanping injection
Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection
Active comparator
Control group of ordinary COVID-19
ritonavir/ritonavir treatment
Drug: Lopinavir/ritonavir treatment
Experimental
Experimental group of severe COVID-19
Lopinavir / ritonavir tablets combined with Xiyanping injection
Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection

Interventions

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

What researchers measure

Primary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04295551
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Responsible party: Sponsor
First posted: Mar 4, 2020
Start date: Mar 14, 2020 (estimated)
Primary completion: Jul 14, 2020 (estimated)
Completion: Apr 14, 2021 (estimated)
Last update: Mar 4, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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