COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49567

Qianxue Chen

chenqx666@whu.edu.cn

2020-02-24

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

(1) Those who meet the diagnosis of new coronavirus pneumonia and have clinical classification of low and medium, (2) Inpatients aged 18 to 75 years, (3) Voluntarily receive treatment with the drug and sign informed consent. The informed consent process complies with relevant GCP regulations.

(1) Immunodeficiency disease, or those who have used immunosuppressive agents or glucocorticoids within the past 3 months, (2) Preparing pregnant, pregnant and lactating women, (3) Patients with allergies (referring to allergies to two or more medicines, foods or known ingredients in this study), (4) Patients with mental illness, or have no cognitive ability, (5) Patients with an estimated survival time of less than 48 hours from the start of screening, (6) Those who have been intubated or mechanically ventilated at the time of screening, (7) Obvious symptoms of heart, liver, kidney or various other systems, ALT, AST exceed 1.5 times the upper limit of normal value, (8) Believed to be not suitable to participate in clinical trials by investigator.

2

Renmin Hospital of Wuhan University

18

75

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

80

CD8+ T cells numbers;CD4+ T cell numbers;NK cell numbers;Fatality rate;Clinical recovery time;Critical (severe or critical) conversion rate;

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

Phase 0

[{"arm_notes": "", "treatment_id": 1079, "treatment_name": "Recombinant human interleukin-2", "treatment_type": "Interleukins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]