COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04268537

Jianfeng Xie

Not reported

2020-02-13

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: adult sari patients with 2019-ncov infection confirmed by pcr; absolute value of lymphocytes < 0. 6x 109/l; severe respiratory failure within 48 hours and requires admission to icu. (severe respiratory failure was defined as pao2/fio2 < 200 mmhg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, peep>=5cmh2o))

age < 18 pregnant allergic to experimental drugs the underlying disease is very serious and the expected survival time is less than 6 months (such as advanced malignant tumor); copd or end-stage lung disease requires home oxygen therapy expected survival time not exceeding 48 hours participated in other clinical intervention trials within the last 3 months autoimmune diseases a history of organ, bone marrow or hematopoietic stem cell transplantation 10. received radiotherapy and chemotherapy for malignant tumor within 6 months 11.hiv infected patients or diagnosed with acquired immunodeficiency within the past year (cd4 t cells <=200/mm3) 12. patients receiving anti-hcv treatment 13.90 days of retinal detachment or eye surgery 14. permanent blindness in one eye 15. history of iritis, endophthalmitis, scleral inflammation or retinitis 16. the competent physician considered it inappropriate to participate in the study

3

Southeast University, China

18

None

None

Severe disease at enrollment

6: Severe disease at enrollment

120

lung injury score

None

Phase 2

[{"arm_notes": "", "treatment_id": 964, "treatment_name": "Pd-1 mab", "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"}]