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A clinical trial for Ulinastatin 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 Ulinastatin Injection in the treatment of patients with severe novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030779
Enrollment
Unknown
Registered
2020-03-14
Start date
2020-03-16
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:Conventional treatent and Ulinastatin
Control group:Conventional treatent

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years; 2. In accordance with NCP criteria for severe and critical illness. Combined with the following epidemiological history, clinical manifestations, and pathogenic examinations to make a comprehensive judgment; 3. Will not participate in other drug clinical trials since the first day of Ulinastatin Injection admission; 4. Will sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian.

Exclusion criteria

Exclusion criteria: 1. With contraindications of Ulinastatin Injection; 2. Pregnant or lactating women; 3. Patients taking other urinary trypsin inhibitors; 4. Not suitable to participate in the clinical trial by investigator's judgement.

Design outcomes

Primary

MeasureTime frame
blood gas;SOFA score;

Secondary

MeasureTime frame
28 natural survival rate;TTCI (Time to Clinical Improvement);Days in hospital;Duration of non-invasive / invasive ventilation;Proportion of severe to light;Infection related data;Frequency of serious adverse events;

Countries

China

Contacts

Public ContactZhaofen Lin,Wansheng Chen,Weifen Xie

Shanghai Changzheng Hospital

linzhaofen@sina.com+86 13601605100, 13301833859, 13701682806

Outcome results

None listed

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