CoVID-19
Conditions
Interventions
Experimental group:Basic treatment + kolimycin
Control group:Basic treatment
Sponsors
Mudanjiang Kang'an Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject or legal agent has signed the informed consent form; agreed to not participate in other clinical researchers within 30 days from the first administration of the study drug to the last administration. 2. Aged 18 to 75 years old; 3. Meet the diagnostic criteria for pneumonia caused by new coronavirus (2019-nCoV) (seventh edition) 4. Treated patients or relapsed patients meet any of the following: (1) Fever again, or the clinical symptoms worsened; (2) The throat swab 2019nCOVRNA was positive; (3) No clinical symptoms improved or 2019nCOVRNA continued positive; (4) Chest CT showed lung inflammation or fibrosis progress.
Exclusion criteria
Exclusion criteria: 1. Other viral pneumonia; 2. Patients who received tumor immunotherapy (such as PD-1 / L1, CTLA4, etc.) and inflammatory factor regulators such as ulinastatin in the past 1 month; 3. Patients who have used macrolides and other antibacterial drugs in the past week; 4. Patients who have undergone organ transplantation or surgery planning within the past 6 months; 5. Patients with coma and intestinal obstruction cannot eat or take medicine; 6. Serious basic diseases that affect survival, including: uncontrolled malignant tumors that have been metastasized and unresectable, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc. 7. Pregnant women and lactating women, subjects (including male subjects) have pregnancy plans (including sperm donation and egg donation plans) or are unable to take effective contraceptive measures within the next 6 months; 8. Patients with allergies or allergies to macrolide drugs and lopinavir / ritonavir tablets; 9. Patients who have contraindications to the use of lopinavir / ritonavir tablets, plan or are using drugs that interact with the drug (including: highly dependent on CYP3A clearance and elevated plasma concentrations will be accompanied by serious and / or endangered Life events [narrow therapeutic index] drugs, CYP3A inducers [see instructions for details], and cannot be stopped or replaced with other drugs; 10. Alanine aminotransferase (ALT) / alanine aminotransferase (AST) rises more than 5 times the upper limit of normal, total bilirubin exceeds 3 times the upper limit of normal, or patients with child-Pugh C liver cirrhosis; 11. In vitro life support (ECMO, ECCO2R, RRT); 12. critically ill patients with an estimated survival time of less than 48 hours; 13. Those who participated in other clinical research within the past month; 14. According to the judgment of the investigator, it is considered unsuitable for the selected patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virus negative time;Medication 3, 5, 7, 9, 11, 13, 15 days mouthwash (pharyngeal swab) 2019-nCOVRNA negative rate (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific antibody IgM, IgG generation time;Changes in peripheral blood white blood cell counts, biochemical indicators, and blood coagulation from baseline on day 1, day 5, day 10, and day 15 after medication;Changes in C-reactive protein from baseline on day 1, day 5, day 10, and day 15 after medication;Hospitalization time and mortality;30-day recovery rate of discharged patients; | — |
Countries
China
Contacts
Public ContactKaijiang Yu
The First Affiliated Hospital of Harbin Medical University
Outcome results
None listed