Efficacy and Safety of ulinastatin in the Treatment of novel coronavirus pneumonia (COVID-19)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032135

Enrollment

Unknown

Registered

2020-04-20

Start date

2020-04-22

Completion date

Unknown

Last updated

2020-05-04

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: mild cases:Ulinastatin 300,000 IU, Q12H

Experimental group: severe or critical cases:Severe cases: 1 million IU of ulinastatin, Q8H

Critical cases: ulinastatin 1.6 million IU, Q8H

Control group: mild cases:conventional therapy

Control group: severe or critical cases :conventional therapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 75 years old, male or female; 2) The confirmed participants were diagnosed as mild, severe or critical cases according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 7); 3) Those who agree not to participate in other clinical studies within 30 days after administration of the study; 4) Patients voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with specific contraindications of ulinastatin; 2) Female subjects had a positive urine pregnancy test or were lactating during the screening period; 3) Patients who are using Civerex and Gabexate; 4) Factors that may increase the mortality rate, which patients with severe other basic diseases such as tumor, severe malnutrition, etc.; 5) The participants who were considered by the researchers were not suitable to participate in the clinical trial.

Design outcomes

Primary

Measure	Time frame
mild cases: the critical illness rate of subjects at weeks 2;Severe or critical cases: the Changes of PaO2/FiO2 from baseline to day 1, 3, 5 and 24 hours later after the last administration;Safety data of COVID-19 patients treated with ulinastatin were collected;	—

Secondary

Measure	Time frame
Lung CT imaging findings;Peripheral blood CD4+ cell count;blood lactic acid;oxygen saturation;The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3, 5, 7;	—

Countries

China

Contacts

Public ContactHongzhou Lu

Shanghai Public Health Clinical Center

luhongzhou@fudan.edu.cn+86 21 37990333

Outcome results

None listed

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