COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49161

Xia Jiaan

3131862959@qq.com

2020-02-14

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1. 2019 adult patients with new-type coronavirus pneumonia diagnosed with 2019-nCoV infection by PCR according to the Pneumonitis Diagnosis and Treatment Protocol for New-type Coronavirus Infection (Trial Version 5) 2. The absolute value of lymphocytes <0.6x10^9/L, 3. Severe respiratory failure does not exceed 48 hours and requires ICU treatment. Among them, severe respiratory failure is defined as PaO2 / FiO2 <200 mmHg and requires positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP >=5 cmH2O), 4. Sign the informed consent.

1. Aged <18 years, 2. Pregnant or lactating women, 3. Allergic to the test drug, 4. The underlying disease is very serious, and the expected survival time is less than 6 months (such as advanced malignant tumors), 5. COPD or end-stage lung disease requires home oxygen therapy, 6. Expected survival time does not exceed 48 hours, 7. Participated in other clinical intervention trials in the past 3 months, 8. Suffering from autoimmune diseases, 9. History of organ, bone marrow or hematopoietic stem cell transplant Received radiotherapy and chemotherapy for malignant tumors within 10.6 months, 11. HIV-infected patients or acquired immune deficiency diagnosed within the past year (CD4 T cells <= 200 / mm3), 12. Patients receiving anti-HCV treatment, 13. 90 days with retinal detachment or eye surgery, 14. Permanent blindness in one eye, 15. History of iritis, endophthalmitis, scleritis, or retinitis, 16. The doctor in charge considers it inappropriate to participate in this study.

3

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)

18

None

China

Critical disease at enrollment

8: Critical disease at enrollment

120

Proportion of patients with a lung injury score reduction of 1-point or more 7 days after randomization;

| Declared number of arm (3.0) differs from found arms (4.0)

Not reported

[{"arm_notes": "", "treatment_id": 246, "treatment_name": "Camrelizumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1289, "treatment_name": "Thymosin", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]