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A randomized, blinded, controlled, multicenter clinical trial to evaluate the efficacy and safety of Ixekizumab combined with conventional antiviral drugs in patients with novel coronavirus pneumonia (COVID-19)

A randomized, blinded, controlled, multicenter clinical trial to evaluate the efficacy and safety of Ixekizumab combined with conventional antiviral drugs in patients with novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030703
Enrollment
Unknown
Registered
2020-03-10
Start date
2020-03-10
Completion date
Unknown
Last updated
2020-03-16

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:Ixekizumab and antiviral therapy
control group:antiviral therapy

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old; 2. The diagnosis of new-type coronavirus pneumonia was confirmed by RT-PCR or gene sequencing according to the "Diagnosis and Treatment Scheme for Pneumonia of New Coronavirus Infection (Trial Version 6 and Updated)", and the clinical type was general (including severe high-risk factors) and severe; Note: Patients with common new type of coronavirus pneumonia (including severe high-risk factors): patients with common type with multiple lung multiple lesions, or pulmonary imaging shows that the lesion progresses significantly within 50% within 24 to 48 hours; 3. IL-6 is elevated (Roche chemiluminescence detection is recommended); 4. The patient voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Critical new pneumonia infection that meets one of the following conditions: respiratory failure occurs and requires mechanical ventilation; shock; combined organ failure requires ICU monitoring and treatment 2. Known allergies to Ixekizumab or antiviral drugs; 3. ALT / AST> 5 times ULN, neutrophils =2 mg/dl (176 umol/l); 5. Combined with severe underlying diseases, the expected life cycle is less than 3 months; 6. Active hepatitis, patients with definite severe bacterial and fungal infections, tuberculosis infection, and HIV infection; 7. Clear diagnosis of malignant tumors such as lymphoproliferative diseases; 8. Known active Crohn's disease; 9. Pregnant or lactating women; 10. Participated in other interventional clinical trials in the past 3 months; 11. Other conditions that the researcher considers unsuitable.

Design outcomes

Primary

MeasureTime frame
Lung CT;

Secondary

MeasureTime frame
Lung function;Arterial blood gas analysis ;

Countries

China

Contacts

Public ContactPinhua Pan, Yehong Kuang

Xiangya Hospital of Central South University

pinhuapan668@126.com+86 13574171102

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026