COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50693

Min Zhang

maggie_zhangmin@163.com

2020-03-08

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

(1) aged 18-80 years old, (2) severe (including critical risk factors) and critical patients with confirmed novel coronavirus pneumonia, (3) blood CRP and ESR were more than twice higher than normal or TNFa and Il-6 were higher than normal, (4) sign the informed consent.

(1) pregnant or breast-feeding women, (2) ALT/AST > 5 times ULN, neutrophils < 0.5x10^9/L, platelets less than 50x10^9/L, (3) definite diagnosis of rheumatoid immunity, malignant tumor and other related diseases, (4) patients with long-term oral immunoregulatory drugs or who had used large doses of glucocorticoids within 14 days, (5) allergic reactions to adamumab or tozumab, (6) active hepatitis, tuberculosis, associated with specific severe bacterial and fungal infections, organ transplantation or mental disorders, (7) received Il-6 monoclonal antibody or TNFa monoclonal antibody within 14 days.

2

Shanghai General Hospital

18

80

China

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

60

chest computerized tomography;Nucleic acid detection of novel coronavirus;TNF-alpha;IL-6;IL-10;

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

Phase 4

[{"arm_notes": "", "treatment_id": 2191, "treatment_name": "Adalimumab+tocilizumab", "treatment_type": "Other targeted therapies+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]