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Efficacy and safety of tozumab combined with adamumab(Qletli) in severe and critical patients with novel coronavirus pneumonia (COVID-19)

Tozumab combined with adamumab(Qletli) in the treatment of severe and critically ill patients with novel coronavirus pneumonia (COVID-19):A prospective, single-center, randomized, parallel controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030580
Enrollment
Unknown
Registered
2020-03-08
Start date
2020-02-01
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:Based on the standard treatment recommended in the guidelines, a combination of tozumab and adamumab was used
control group:Follow the guidelines for standard treatment

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactMin Zhang

Shanghai General Hospital

maggie_zhangmin@163.com+86 18121288279

Outcome results

None listed

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