COVID-19Phase 1/2NCT04393311
Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
A Phase 1/2 study testing Ulinastatin in people with COVID-19, run by Stanford University at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Ulinastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2022to Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19.
- Conditions
- COVID-19
- Being tested
- Ulinastatin, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Ulinastatin administered via IV infusion (200,000/infusion)
PlaceboDrug
Placebo to match ulinastatin administered via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Ulinastatin | Experimental | Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier). Receives: Drug: Ulinastatin |
| Placebo | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery
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
Measured: Up to 29 days
Secondary outcomes (15)
COVID-19 disease severity scale score on Day 8
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Measured: Day 8
COVID-19 disease severity scale score on Day 15
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Measured: Day 15
COVID-19 disease severity scale score on Day 22
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Measured: Day 22
COVID-19 disease severity scale score on Day 29
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Measured: Day 29
Incidence of mortality at Day 29
Measured: 29 days
Incidence of in-hospital mortality
Measured: Up to 29 days
Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
Measured: 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
Measured: 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
Measured: Day 29
Duration of mechanical ventilation
For patients requiring mechanical ventilation.
Measured: Up to 29 days
Duration of ECMO
For patients requiring mechanical ECMO.
Measured: Up to 29 days
Duration of noninvasive ventilation
For patients requiring non-invasive ventilation
Measured: Up to 29 days
Duration of ICU stay
For patients admitted to ICU
Measured: Up to 29 days
Duration of hospital stay
Measured: Up to 29 days
Change in oxygen saturation
Measured: Between screening and 24 hours after last dose (up to 6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study startFeb 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Discontinuation of drug candidates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin V Grimes, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393311
- Sponsor's protocol ID
- 56639
- Status last verified
- Feb 2022
- First submitted
- 15 May 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04393311
- Acronym / sponsor ID
- 56639
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Discontinuation of drug candidates
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulinastatin | Experimental | Drug: UlinastatinPatients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier). |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo to match ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UlinastatinUlinastatin administered via IV infusion (200,000/infusion) | Drug | Ulinastatin |
| PlaceboPlacebo to match ulinastatin administered via IV infusion | Drug | Placebo |
Primary outcome
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). 1. = Death; 2. = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; 4. = Hospitalized and requiring supplemental oxygen; 5. = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); 6. = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; 7. = Not hospitalized, limitation on activities and/or requiring home oxygen; 8. = Not hospitalized, no limitation on activities
15 secondary outcomes
COVID-19 disease severity scale score on Day 8
Time frame: Day 8
COVID-19 disease severity scale score on Day 15
Time frame: Day 15
COVID-19 disease severity scale score on Day 22
Time frame: Day 22
COVID-19 disease severity scale score on Day 29
Time frame: Day 29
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
Duration of ECMO
Time frame: Up to 29 days
Duration of noninvasive ventilation
Time frame: Up to 29 days
Duration of ICU stay
Time frame: Up to 29 days
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No. No plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin V Grimes, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ulinastatin in people with COVID-19, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery (time frame: Up to 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.