Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04393311 |
Recruitment Status :
Withdrawn
(Discontinuation of drug candidates)
First Posted : May 19, 2020
Last Update Posted : March 3, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Ulinastatin Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients |
Estimated Study Start Date : | February 2022 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | August 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Ulinastatin
Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
|
Drug: Ulinastatin
Ulinastatin administered via IV infusion (200,000/infusion) |
Placebo Comparator: Placebo
Patients will receive placebo to match ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
|
Drug: Placebo
Placebo to match ulinastatin administered via IV infusion |
- Time to recovery [ Time Frame: Up to 29 days ]
Time to recovery, defined as attaining a score of 6, 7, or 8 on the COVID-19 disease severity scale, an 8 point ordinal scale used in the NIH Adaptive COVID-19 Treatment Trial (ACTT; NCT04280705).
- = Death;
- = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
- = Hospitalized and on non-invasive ventilation or high-flow oxygen devices;
- = Hospitalized and requiring supplemental oxygen;
- = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise);
- = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care;
- = Not hospitalized, limitation on activities and/or requiring home oxygen;
- = Not hospitalized, no limitation on activities
- COVID-19 disease severity scale score on Day 8 [ Time Frame: Day 8 ]COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
- COVID-19 disease severity scale score on Day 15 [ Time Frame: Day 15 ]COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
- COVID-19 disease severity scale score on Day 22 [ Time Frame: Day 22 ]COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
- COVID-19 disease severity scale score on Day 29 [ Time Frame: Day 29 ]COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
- Incidence of mortality at Day 29 [ Time Frame: 29 days ]
- Incidence of in-hospital mortality [ Time Frame: Up to 29 days ]
- Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose [ Time Frame: Up to 29 days ]
- Number of patients with resolution of symptoms defined as score of 8 on the 8-point ordinal scale at Day 29 [ Time Frame: Day 29 ]
- Number of patients alive and free of respiratory failure defined as score of 4, 5, 6, 7, or 8 on the 8-point ordinal scale at Day 29 [ Time Frame: Day 29 ]
- Duration of mechanical ventilation [ Time Frame: Up to 29 days ]For patients requiring mechanical ventilation.
- Duration of ECMO [ Time Frame: Up to 29 days ]For patients requiring mechanical ECMO.
- Duration of noninvasive ventilation [ Time Frame: Up to 29 days ]For patients requiring non-invasive ventilation
- Duration of ICU stay [ Time Frame: Up to 29 days ]For patients admitted to ICU
- Duration of hospital stay [ Time Frame: Up to 29 days ]
- Change in oxygen saturation [ Time Frame: Between screening and 24 hours after last dose (up to 6 days) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to provide written informed consent
- Signs and symptoms suggestive of COVID-19 infection
- Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ≤7 days before randomization
- Currently hospitalized or in an emergency department with planned hospitalization
- Peripheral capillary oxygen saturation (SpO2) <93% on room air at Screening
Exclusion Criteria:
- Simultaneous participation in any other clinical study incompatible with this one
- Treatment with an antibody immunotherapy within 4 weeks of Screening
- Requirement for mechanical ventilation or ECMO at Screening
- Hypotension at Screening
- Severe liver injury defined as AST or ALT ≥5x the upper limit of normal
- Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) <30 mL/min
- Pregnancy or breastfeeding
- > 120 hours between admission and signing consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393311
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 |
Principal Investigator: | Kevin V Grimes, MD | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT04393311 |
Other Study ID Numbers: |
56639 |
First Posted: | May 19, 2020 Key Record Dates |
Last Update Posted: | March 3, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plan to share data. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Urinastatin Trypsin Inhibitors Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |