COVID-19
Conditions
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.
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
Sponsors
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical recovery time | Up to Day 28 | The time from study drug use to complete fever reduction and cough recovery is measured in hours. |
Outcome results
None listed