COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=52824

Kaijiang Yu

drkaijiang@163.com

2020-04-24

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

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.

2

Mudanjiang Kang'an Hospital

18

75

China

Severe disease at enrollment

6: Severe disease at enrollment

350

Virus negative time;Medication 3; 5; 7; 9; 11; 13; 15 days mouthwash (pharyngeal swab) 2019-nCOVRNA negative rate (%);

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 0

[{"arm_notes": "", "treatment_id": 705, "treatment_name": "Kolimycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]