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A clinical study for the efficacy and safety of Adalimumab Injection in the treatment of patients with severe novel coronavirus pneumonia (COVID-19)

A randomized, open-label, controlled trial for the efficacy and safety of Adalimumab Injection in the treatment of patients with severe novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030089
Enrollment
Unknown
Registered
2020-02-22
Start date
2020-02-28
Completion date
Unknown
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia(COVID-19)

Interventions

Experimental group:Conventional treatent and adalimumab
Control group:conventional treatment

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects who meet the following conditions can become subjects of this study: 1. Will sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian; 2. Chinese aged >=18 years; 3. In accordance with NCP criteria for severe and critical illness, namely "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)". Combined with the following epidemiological history, clinical manifestations, and pathogenic examinations to make a comprehensive judgment. 4. The course of disease is within 14 days after the onset of illness; 5. Will take nasopharyngeal or oropharyngeal swabs before administration.

Exclusion criteria

Exclusion criteria: 1. Patients who are participating in other drug clinical trials; 2. Pregnant or lactating women; 3. ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50; 4. Expected survival is less than 1 week; 5. Patients diagnosed with rheumatic immune related diseases; 6. Take orally anti rejection drugs or immunomodulatory drugs for a long time; 7. Hypersensitive to adalimumab or any excipients; 8. Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections

Design outcomes

Primary

MeasureTime frame
TTCI (Time to Clinical Improvement);

Secondary

MeasureTime frame
All-cause mortality;Time for body temperature to return to normal;Time of improvement in respiratory symptoms;Proportion of severe to light;Days in hospital;Duration of non-invasive / invasive ventilation;Frequency of serious adverse events;inflammatory factors;

Countries

China

Contacts

Public ContactHuji Xu

Shanghai Changzheng Hospital

xuhuji@smmu.edu.cn+86 13671609764

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026