SepsisPhase 3CURE-SepSIRSNCT05391789
Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome
A Phase 3 study testing Ulinastatin in people with Sepsis, run by Huashan Hospital at 1 site in China.
Trial summary
Sepsis is a life-threatening organ dysfunction caused by the maladjusted response of the host to infection. It is a clinical syndrome with high mortality. Studies have confirmed that many cytokines play a vital role in the pathogenesis of sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to 20 Jun 2024
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sepsis-3 specified by SCCM and ESICM 1) suspected or confirmed infection: diagnosed by a clinician 2) evidence of acute organ dysfunction: for patients without chronic organ dysfunction in the past (assuming a baseline SOFA score of 0): sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection for patients with chronic organ dysfunction in the past (SOFA score should be based on baseline): the increase of sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection
- diagnosis of sepsis for less than 48 hours
- Systemic inflammatory response syndrome (SIRS) 1) body temperature > 38 ℃ or < 36 ℃ 2) heart rate > 90 3) respiratory rate> 20 4) WBC count > 12 × 10 ^ 9 / L or < 4 × 10^9/L (>12000/ μ L or < 4000/ μ L or immature granulocytes > 10%)
- Obtained informed consent signed by the patient or authorized immediate family member
Who cannot join
- Congestive heart failure (NYHA heart function level 4), cerebrovascular accident or acute coronary syndrome within 3 months, cardiac arrest within 7 days of this hospitalization, non-infectious cardiogenic shock, uncontrolled acute bleeding
- Severe chronic liver disease (Child-Pugh grade C), liver parenchymal lesions with obvious portal hypertension, acute liver failure
- Chronic renal failure, received dialysis treatment before being selected
- Severe coagulation function: ISTH-DIC score ≥ 5 points
- Significant immune abnormality/injury: received organ or bone marrow transplantation within 3 months before screening, moderate to severe leukopenia such as neutrophils <1.5×10^9/L, received radiotherapy or chemotherapy within 3 months , HIV seropositivity, active blood/lymphatic system tumor
- Have received Xuebijing, thymosin or gamma globulin treatment within 3 months before being selected for the study
- Others: allergies to study drugs, pregnancy, breast-feeding, participating in other clinical trials within 3 months, and other conditions deemed unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital affiliated to Fudan University
Jingan, Shanghai Municipality
About this study
Official title: Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome: a Multicenter, Randomized, Double-blind, Multi Dose and Placebo-controlled Clinical Trial.
Sepsis is a life-threatening organ dysfunction caused by the maladjusted response of the host to infection. It is a clinical syndrome with high mortality. Studies have confirmed that many cytokines play a vital role in the pathogenesis of sepsis. Ulinastatin (UTI) is a glycoprotein that exists in human blood and can be isolated and purified from human urine. It is a broad-spectrum protease inhibitor. Previous studies have shown that Ulinastatin may have the effect of treating sepsis.
120 septic patients with systemic inflammatory response syndrome were recruited and randomly assigned to the ordinary-dose group, high-dose group, or placebo in a 1:1:1 ratio. The trial was followed up on days 0, 1, 3, 5, 7 and 28. The primary outcome is the change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 5 (ΔSOFA). All-cause mortality at day 28 is a secondary outcome.
Read the detailed description
This completed multicenter randomized trial enrolled 120 adults with sepsis and systemic inflammatory response syndrome (SIRS). After informed consent, the enrollment day was Day 0. Participants were randomly assigned 1:1:1 to an ordinary-dose group, a high-dose group, or a placebo control group, and baseline clinical information was collected.
The ordinary-dose group received ulinastatin 400,000 units intravenously every 8 hours. The high-dose group received ulinastatin 800,000 units intravenously every 8 hours. The control group received an equal volume of 0.9% saline (50 mL) intravenously every 8 hours. When SIRS criteria were no longer met, the assigned dose (or matching placebo volume) was halved and continued; treatment lasted at least 3 days and up to 7 days.
Inclusion criteria:
- Adults ≥18 and ≤80 years of age; 2) sepsis according to Sepsis-3; 3) sepsis diagnosis <48 hours; 4) SIRS; 5) written informed consent from the patient or a legally authorized representative.
Exclusion criteria:
- Congestive heart failure with NYHA class IV function, cerebrovascular accident or acute coronary syndrome within 3 months, in-hospital or recent (within 7 days) cardiac arrest, non-infectious cardiogenic shock, or uncontrolled acute bleeding; 2) severe chronic liver disease (Child-Pugh C), liver parenchymal disease with significant portal hypertension, or acute liver failure; 3) chronic renal failure with dialysis before enrollment; 4) severe coagulopathy (ISTH DIC score ≥5); 5) significant immune impairment (organ or bone marrow transplantation; moderate or severe leukopenia within 3 months before screening, e.g. neutrophils <1.5×10^9/L; radiotherapy or chemotherapy within 3 months; HIV seropositivity; active hematologic or lymphatic malignancy); 6) Xuebijing, thymosin, or gamma globulin within 3 months before enrollment; 7) allergy to study drug, pregnancy, lactation, participation in another clinical trial within 3 months, or other conditions judged by the investigator to preclude participation.
Follow-up visits were on days 0, 1, 3, 5, 7, and 28. The primary outcome is the change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 5 (ΔSOFA). Secondary outcomes include SOFA at other visits, 28-day all-cause mortality, ICU stay, duration of antibiotics, SIRS, vasoactive drugs, mechanical ventilation and CRRT, and laboratory measures of infection, inflammation, coagulation, liver and kidney function, neurological and mental status, and endothelial injury.
- Conditions
- Sepsis
- Being tested
- Ulinastatin, Placebo
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Also called Treatment
Patients would be given 400000 or 800000units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days
PlaceboDrug
Also called Control
Patients would be given 50 ml of 0.9% normal saline intravenously for at least 1 hour once every 8 hours.It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), continue to use it for 2 days, with a total course of treatment of at least 3 days.
| Study group | Role | What they receive |
|---|---|---|
| normal dose | Experimental | Patients would be given 400000 units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days Receives: Drug: Ulinastatin |
| high dose | Experimental | Patients would be given 800000 units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days Receives: Drug: Ulinastatin |
| placebo | Placebo comparator | Patients would be given 50 ml of 0.9% normal saline intravenously for at least 1 hour once every 8 hours.It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), continue to use it for 2 days, with a total course of treatment of at least 3 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
delta sofa, ΔSOFA
Sequential organ failure asses(SOFA) of day 5 , compared with the baseline.
Measured: Day 5
Secondary outcomes (26)
Sofa vs. baseline change in sofa at randomization (delta sofa, Δ SOFA）
Sequential Organ Failure Assessment
Measured: Day 1,3,7
28 day all-cause mortality
28 day all-cause mortality
Measured: Day 28
ICU hospitalization days
ICU hospitalization days
Measured: Day 28
antibiotic use days
antibiotic use days
Measured: Day 28
SIRS days
SIRS days
Measured: Day 28
vasoactive drugs days
vasoactive drugs days
Measured: Day 28
mechanical ventilation days
mechanical ventilation days
Measured: Day 28
CRRT days
CRRT days
Measured: Day 28
Blood routine
Blood routine
Measured: Day 1,3,5,7
coagulation and fibrinolysis indexes: PT, PLT, D-dimer
coagulation and fibrinolysis indexes
Measured: Day 1,3,5,7
DIC score
The ISTH group produced a simple scoring system for the diagnosis of DIC depending on the Platelet count, the PT, the fibrinogen level and critically the FDP/D-Dimer results. A person's ISTH DIC score ranges from 0 to 8. <5 is suggestive of non-overt/low grade DIC. ≥5 means laboratory evidence is consistent with overt DIC
Measured: Day 1,3,5,7
AST, ALT, bilirubin
Liver function
Measured: Day 1,3,5,7
urine volume
urine volume
Measured: Day 1,3,5,7
creatinine
creatinine
Measured: Day 1,3,5,7
urea nitrogen
urea nitrogen
Measured: Day 1,3,5,7
blood lactate
blood lactate
Measured: Day 1,3,5,7
oxygenation index
oxygenation index
Measured: Day 1,3,5,7
oxygen saturation
oxygen saturation
Measured: Day 1,3,5,7
Glasgow Coma Scale
Glasgow Coma Scale. A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive). A lower score means a more serious condition.
Measured: Day 1,3,5,7
days of delirium and coma
days of delirium and coma
Measured: Day 1,3,5,7
APACHE-II on day 5
Acute Physiology and Chronic Health Evaluation
Measured: Day 5
ADL on day 1,3,5,7;
Activities of Daily Living score
Measured: Day 1,3,5,7
intercellular adhesion factor
Endothelial cell function
Measured: Day 1,3,7
concentration of endothelial cell specific molecules
Endothelial cell function
Measured: Day 1,3,7
heparan sulfate
Endothelial cell function
Measured: Day 1,3,7
lymphocyte subsets and inflammatory factor levels (IL-6, IL-10, CRP, PCT, TNF- α、 HMGB-1）
Immune and inflammatory indexes
Measured: Day 1,3,7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start10 Nov 2022
- Primary completion28 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Wenhong, Professor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391789
- Sponsor's protocol ID
- KY2021-924
- Acronym
- CURE-SepSIRS
- Status last verified
- Sep 2026
- First submitted
- 28 Dec 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome: a Multicenter, Randomized, Double-blind, Multi Dose and Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05391789
- Acronym / sponsor ID
- CURE-SepSIRS / KY2021-924
- Conditions
- Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 26 May 2022 (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.
Sepsis is a life-threatening organ dysfunction caused by the maladjusted response of the host to infection. It is a clinical syndrome with high mortality. Studies have confirmed that many cytokines play a vital role in the pathogenesis of sepsis. Ulinastatin (UTI) is a glycoprotein that exists in human blood and can be isolated and purified from human urine. It is a broad-spectrum protease inhibitor. Previous studies have shown that Ulinastatin may have the effect of treating sepsis.
120 septic patients with systemic inflammatory response syndrome were recruited and randomly assigned to the ordinary-dose group, high-dose group, or placebo in a 1:1:1 ratio. The trial was followed up on days 0, 1, 3, 5, 7 and 28. The primary outcome is the change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 5 (ΔSOFA). All-cause mortality at day 28 is a secondary outcome.
Detailed description
This completed multicenter randomized trial enrolled 120 adults with sepsis and systemic inflammatory response syndrome (SIRS). After informed consent, the enrollment day was Day 0. Participants were randomly assigned 1:1:1 to an ordinary-dose group, a high-dose group, or a placebo control group, and baseline clinical information was collected.
The ordinary-dose group received ulinastatin 400,000 units intravenously every 8 hours. The high-dose group received ulinastatin 800,000 units intravenously every 8 hours. The control group received an equal volume of 0.9% saline (50 mL) intravenously every 8 hours. When SIRS criteria were no longer met, the assigned dose (or matching placebo volume) was halved and continued; treatment lasted at least 3 days and up to 7 days.
Inclusion criteria:
- Adults ≥18 and ≤80 years of age; 2) sepsis according to Sepsis-3; 3) sepsis diagnosis <48 hours; 4) SIRS; 5) written informed consent from the patient or a legally authorized representative.
Exclusion criteria:
- Congestive heart failure with NYHA class IV function, cerebrovascular accident or acute coronary syndrome within 3 months, in-hospital or recent (within 7 days) cardiac arrest, non-infectious cardiogenic shock, or uncontrolled acute bleeding; 2) severe chronic liver disease (Child-Pugh C), liver parenchymal disease with significant portal hypertension, or acute liver failure; 3) chronic renal failure with dialysis before enrollment; 4) severe coagulopathy (ISTH DIC score ≥5); 5) significant immune impairment (organ or bone marrow transplantation; moderate or severe leukopenia within 3 months before screening, e.g. neutrophils <1.5×10^9/L; radiotherapy or chemotherapy within 3 months; HIV seropositivity; active hematologic or lymphatic malignancy); 6) Xuebijing, thymosin, or gamma globulin within 3 months before enrollment; 7) allergy to study drug, pregnancy, lactation, participation in another clinical trial within 3 months, or other conditions judged by the investigator to preclude participation.
Follow-up visits were on days 0, 1, 3, 5, 7, and 28. The primary outcome is the change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 5 (ΔSOFA). Secondary outcomes include SOFA at other visits, 28-day all-cause mortality, ICU stay, duration of antibiotics, SIRS, vasoactive drugs, mechanical ventilation and CRRT, and laboratory measures of infection, inflammation, coagulation, liver and kidney function, neurological and mental status, and endothelial injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal dose | Experimental | Drug: UlinastatinPatients would be given 400000 units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days |
| high dose | Experimental | Drug: UlinastatinPatients would be given 800000 units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days |
| placebo | Placebo comparator | Drug: PlaceboPatients would be given 50 ml of 0.9% normal saline intravenously for at least 1 hour once every 8 hours.It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), continue to use it for 2 days, with a total course of treatment of at least 3 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sepsis-3 specified by SCCM and ESICM 1) suspected or confirmed infection: diagnosed by a clinician 2) evidence of acute organ dysfunction: for patients without chronic organ dysfunction in the past (assuming a baseline SOFA score of 0): sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection for patients with chronic organ dysfunction in the past (SOFA score should be based on baseline): the increase of sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection
- diagnosis of sepsis for less than 48 hours
- Systemic inflammatory response syndrome (SIRS) 1) body temperature > 38 ℃ or < 36 ℃ 2) heart rate > 90 3) respiratory rate> 20 4) WBC count > 12 × 10 ^ 9 / L or < 4 × 10^9/L (>12000/ μ L or < 4000/ μ L or immature granulocytes > 10%)
- Obtained informed consent signed by the patient or authorized immediate family member
Key exclusion criteria (7 listed)
- Congestive heart failure (NYHA heart function level 4), cerebrovascular accident or acute coronary syndrome within 3 months, cardiac arrest within 7 days of this hospitalization, non-infectious cardiogenic shock, uncontrolled acute bleeding
- Severe chronic liver disease (Child-Pugh grade C), liver parenchymal lesions with obvious portal hypertension, acute liver failure
- Chronic renal failure, received dialysis treatment before being selected
- Severe coagulation function: ISTH-DIC score ≥ 5 points
- Significant immune abnormality/injury: received organ or bone marrow transplantation within 3 months before screening, moderate to severe leukopenia such as neutrophils <1.5×10^9/L, received radiotherapy or chemotherapy within 3 months , HIV seropositivity, active blood/lymphatic system tumor
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 |
|---|---|---|
| UlinastatinAlso: TreatmentPatients would be given 400000 or 800000units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days | Drug | high dose, normal dose |
| PlaceboAlso: ControlPatients would be given 50 ml of 0.9% normal saline intravenously for at least 1 hour once every 8 hours.It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), continue to use it for 2 days, with a total course of treatment of at least 3 days. | Drug | placebo |
Primary outcome
delta sofa, ΔSOFA
Time frame: Day 5
Sequential organ failure asses(SOFA) of day 5 , compared with the baseline.
26 secondary outcomes
Sofa vs. baseline change in sofa at randomization (delta sofa, Δ SOFA）
Time frame: Day 1,3,7
28 day all-cause mortality
Time frame: Day 28
ICU hospitalization days
Time frame: Day 28
antibiotic use days
Time frame: Day 28
SIRS days
Time frame: Day 28
vasoactive drugs days
Time frame: Day 28
mechanical ventilation days
Time frame: Day 28
CRRT days
Time frame: Day 28
Blood routine
Time frame: Day 1,3,5,7
coagulation and fibrinolysis indexes: PT, PLT, D-dimer
Time frame: Day 1,3,5,7
DIC score
Time frame: Day 1,3,5,7
AST, ALT, bilirubin
Time frame: Day 1,3,5,7
urine volume
Time frame: Day 1,3,5,7
creatinine
Time frame: Day 1,3,5,7
urea nitrogen
Time frame: Day 1,3,5,7
blood lactate
Time frame: Day 1,3,5,7
oxygenation index
Time frame: Day 1,3,5,7
oxygen saturation
Time frame: Day 1,3,5,7
Glasgow Coma Scale
Time frame: Day 1,3,5,7
days of delirium and coma
Time frame: Day 1,3,5,7
APACHE-II on day 5
Time frame: Day 5
ADL on day 1,3,5,7;
Time frame: Day 1,3,5,7
intercellular adhesion factor
Time frame: Day 1,3,7
concentration of endothelial cell specific molecules
Time frame: Day 1,3,7
heparan sulfate
Time frame: Day 1,3,7
lymphocyte subsets and inflammatory factor levels (IL-6, IL-10, CRP, PCT, TNF- α、 HMGB-1）
Time frame: Day 1,3,7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Wenhong Wenhong, Professor principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ulinastatin in people with Sepsis, run by Huashan Hospital at 1 site in China.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 23 Sep 2026. 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 China. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
delta sofa, ΔSOFA (time frame: Day 5). 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 23 Sep 2026.