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A multicenter, single arm, open label trial for the efficacy and safety of CMAB806 in the treatment of cytokine release syndrome of novel coronavirus pneumonia (COVID-19)

A multicenter, single arm, open label trial for the efficacy and safety of CMAB806 in the treatment of cytokine release syndrome of novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030196
Enrollment
Unknown
Registered
2020-02-25
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-03-02

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

Conditions

cytokine release syndrome of new coronavirus pneumonia (COVID-19)

Interventions

Case series:conventional therapy+tocilizumab

Sponsors

Central South Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients volunteered to sign the informed consent; 2. Patients who were diagnosed with the common type of NCP and severe cases of new coronavirus pneumonia, Referring to the New Coronavirus Pneumonia Diagnosis and Treatment Plan, with elevation of IL-6, and grade 2-3 CRS.In the case of atypical signs of CRS, he or she should be judged by the investigator; 3. Aged >=18 years.

Exclusion criteria

Exclusion criteria: 1. People with serious or uncontrolled concomitant diseases, including sensory, vascular, heart, liver, kidney, gastric, intestinal, endocrine, etc.; 2. Having received Vaccine in the 4 weeks before entry or Planning to receive vaccine during the study; 3. Hypersensitivity to tocilizumab; 4. Pregnant or positive of the pregnancy test, lactating women; 5. Other reasons to exclude from the study.

Design outcomes

Secondary

MeasureTime frame
including AE, SAE, laboratory findings, symptoms, vital signs, ECG, Physical examination.;The time to relive;The recurrence of CRS;The change of IL-1, IL-6, IFN-gama, TNF-alpha;

Primary

MeasureTime frame
the relive of CRS;

Countries

china

Contacts

Public ContactZhiyong Peng

Central South Hospital, Wuhan University

Pengzy5@hotmail.com+86 18672396028

Outcome results

None listed

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