COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49514

Ronghua Jin

dinghuiguo@medmail.com.cn

2020-02-15

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Subjects have signed informed consent, agree not to participate in other clinical studies within 30 days from the first administration of the research drug to the last administration. 2. Aged >= 18 and <= 75 years. 3. Met the diagnostic criteria for COVID-19 (fifth edition, China). 4. SOFA score: 2 to 13 points. COVID-19 clinical stratifications: 1. Mild (n = 200): The clinical symptoms are mild or asymptomatic, and no pneumonia is seen on imaging, but the throat swab or mouthwash 2019-nCOV is positive. 2. General type (n = 160): with fever, respiratory tract symptoms, etc. Imaging shows pneumonia. 3. Severe type (n = 80): Meet any of the following criteria. (1) Respiratory distress, RR >= 30 times / minute. (2) In the resting state, the oxygen saturation is <= 93%. (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <= 300mmHg (1mmHg = 0.133kPa). 4. Critical type (n = 80): One of the following criteria: (1) Respiratory failure (ARDS) occurs and requires mechanical ventilation. (2) Shock. (3) Combined failure of other organs requires ICU monitoring and treatment.

1. Patients who have received immunotherapy (such as PD-1 / L1, CTLA4, etc.) and inflammatory factor modulators (such as Ulinastatin) within one month. 2. Patients who have used antibacterial drugs such as macrolides within one week. 3. Patients who have received other anti-2019-nCOV potentially effective drugs such as Lopinavir and Ritonavir within one week. 4. Those who have undergone organ transplantation or surgery planning within 6 months. 5. Patients with coma or intestinal obstruction can not eat or take medicine. 6. With severe illness affected survival, including uncontrolled malignant tumors that have been metastatic and can not be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.. 7. Pregnant and lactating women, subjects (including male subjects) have a pregnancy plan (including sperm donation, egg donation plan) within the next 6 months or are unable to take effective contraceptive measures. 8. Patients with allergies or allergies to macrolide drugs, lopinavir / ritonavir tablets. 9. Patients with contraindications to using lopinavir / ritonavir tablets who plan or are using drugs that interact with the drug (including: highly dependent on CYP3A clearance and increased plasma concentrations can be severe and / or Life-threatening events [narrow therapeutic index] drugs, CYP3A inducers [see the instructions for details]), and can not be stopped or switched to other drugs. 10. Elevated alanine aminotransferase (ALT) / glutaminase (AST) is more than five times the upper limit of normal, total bilirubin is three times the upper limit of normal, or child-Pugh grade C cirrhosis. 11. Extracorporeal life support (ECMO, ECCO2R, RRT). 12. Critical patients with an estimated survival time of < 48 h. 13. Participants in other clinical research in the past month. 14. At the investigator's discretion, patients were deemed unsuitable for inclusion.

2

Beijing You'an Hospital; Capital Medical University

18

75

China

No restriction on type of patients

0: No restriction on type of patients

520

Body temperature returns to normal time;Pulmonary inflammation resolution time (HRCT);Mouthwash (pharyngeal swab) at the end of treatment COVID-19 RNA negative rate;

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

Phase 4

[{"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 256, "treatment_name": "Carrimycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}]