SepsisRAISENCT07866118
Thymalfasin for Immune Recovery in Adults With Sepsis
A study testing Thymalfasin (Thymosin alpha 1, Ta1) in people with Sepsis and Immunosuppression, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Sepsis is a life-threatening illness caused by an abnormal response to infection. Some people with sepsis have reduced immune function, which may make recovery more difficult. This study will examine whether adding thymalfasin, also called thymosin alpha-1, to usual sepsis care improves recovery of immune function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Immunosuppression
- What is being tested?
- Thymalfasin (Thymosin alpha 1, Ta1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age older than 18 years, of any sex. Sepsis according to Sepsis-3 criteria, defined as documented or suspected infection with an increase in Sequential Organ Failure Assessment (SOFA) score of at least 2 points from baseline.
- APACHE II score of 15 to 30, inclusive, at ICU admission. An immunosuppressed phenotype, defined by reduced monocyte HLA-DR expression meeting No more than 48 hours from sepsis onset to enrollment. Written informed consent provided by the participant or legally authorized representative.
Who cannot join
- Known allergy to thymalfasin or any of its excipients. A history of primary or acquired immunodeficiency, such as HIV infection or post-transplant immunosuppression.
- Treatment with immunosuppressive agents or immunostimulants within 3 months before enrollment, including systemic corticosteroids at a prednisone-equivalent dose greater than 20 mg/day for at least 7 consecutive days, cyclosporine, tacrolimus, or azathioprine.
- Active malignancy or ongoing anticancer treatment. Chronic liver disease classified as Child-Pugh class C, or end-stage renal disease requiring maintenance dialysis.
- Pregnancy or breastfeeding. Expected survival of less than 48 hours at enrollment, such as irreversible brain death after cardiac arrest or terminal multiple organ failure.
- Concurrent participation in another interventional clinical trial. Any other condition that, in the investigator's judgment, makes participation unsuitable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Hongyu He, 13564155433, he.hongyu@zs-hospital.sh.cn
About this study
Official title: A Prospective, Randomized, Controlled Mechanism Study of Thymosin Alpha-1 in Reshaping the "Immune Resilience" Trajectory of Immunosuppressed Sepsis Patients
Sepsis is a life-threatening illness caused by an abnormal response to infection. Some people with sepsis have reduced immune function, which may make recovery more difficult. This study will examine whether adding thymalfasin, also called thymosin alpha-1, to usual sepsis care improves recovery of immune function.
The study will enroll 60 adults with sepsis and evidence of reduced immune function at Zhongshan Hospital, Fudan University. Participants will be assigned by chance to one of two groups. Thirty participants will receive usual care plus a 1.6 mg thymalfasin injection under the skin twice daily for 7 days. Thirty participants will receive usual care alone, without study-drug or placebo injections.
Participants and treating clinicians will know which treatment is given, but laboratory staff measuring immune outcomes will not know the assigned group. The main outcome is the change in monocyte HLA-DR expression, a blood marker of immune function, between baseline and Day 7. Other assessments include immune cells, organ function, organ support, infections, survival, and safety. Scheduled follow-up continues through Day 90. The study is designed primarily to assess an immune marker; it is not sized to establish a definitive survival benefit.
Read the detailed description
This investigator-initiated, single-center, prospective, randomized, controlled exploratory study will evaluate thymalfasin in adults with sepsis and an immunosuppressed phenotype. The study will be conducted in the Department of Critical Care Medicine at Zhongshan Hospital, Fudan University.
Eligible participants will meet Sepsis-3 criteria, have an Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 15 to 30 at ICU admission, and meet the protocol-defined monocyte HLA-DR eligibility criterion. Enrollment must occur within 48 hours of sepsis onset. Written informed consent will be obtained from the participant or a legally authorized representative.
Sixty participants will be randomized in a 1:1 ratio. The experimental group will receive standard sepsis care plus thymalfasin 1.6 mg subcutaneously twice daily, approximately 12 hours apart, for 7 consecutive days. The control group will receive standard sepsis care alone. Standard care will be determined by the treating clinicians and may include infection source control, antimicrobial therapy, fluid resuscitation, vasopressors, and organ support as clinically indicated.
The primary outcome is the change in monocyte HLA-DR expression from baseline before randomization to Day 7. Expression will be assessed by flow cytometry using Panel 1 of the six-panel immunophenotyping method and summarized as the median HLA-DR fluorescence intensity within the prespecified monocyte population. Full-panel immune assessments are scheduled at baseline and Day 7, with core assessments at Days 1, 3, and 14. The protocol specifies immune recovery slopes using measurements at baseline and Days 3, 7, and 14. Samples will be coded, and laboratory personnel will be blinded to treatment allocation.
Secondary assessments will characterize immune recovery, T-cell phenotypes, natural killer cells, organ dysfunction, organ support, and survival. Mortality comparisons are exploratory because the sample size is based on the primary immunological outcome. Safety events will be assessed during the protocol-defined monitoring period. Scheduled survival follow-up continues through Day 90.
- Conditions
- Sepsis, Immunosuppression
- Being tested
- Thymalfasin (Thymosin alpha 1, Ta1)
- Keywords
- Thymalfasin, Thymosin alpha-1, Monocyte HLA-DR, Immune resilience, Immunoparalysis, T-cell exhaustion
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymalfasin (Thymosin alpha 1, Ta1)Drug
Thymalfasin lyophilized powder for injection, 1.6 mg per vial, will be reconstituted with 1 mL of 0.9% sodium chloride and administered subcutaneously at a dose of 1.6 mg twice daily, approximately 12 hours apart, for 7 consecutive days. Injection sites will be rotated between the upper arm and abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Thymalfasin Plus Standard Care | Experimental | Participants will receive standard sepsis care plus thymalfasin 1.6 mg subcutaneously twice daily, approximately 12 hours apart, for 7 consecutive days (Days 1 to 7). Thirty participants are planned for this arm. Receives: Drug: Thymalfasin (Thymosin alpha 1, Ta1) |
| Standard Care Alone | No intervention | Participants will receive standard sepsis care determined by the treating clinicians, including infection source control, antimicrobial therapy, fluid resuscitation, vasopressors, and organ support as clinically indicated. No thymalfasin or placebo injections will be given as study interventions. Thirty participants are planned for this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Monocyte HLA-DR Expression at Day 7
Monocyte HLA-DR expression will be assessed by standardized multiparametric flow cytometry according to the six-panel immunophenotyping method and reported as median fluorescence intensity (MFI). Change will be calculated as the Day 7 MFI minus the baseline MFI measured before randomization. A positive change indicates increased monocyte HLA-DR expression.
Measured: Baseline (Day 0, before randomization) and Day 7
Secondary outcomes (17)
Recovery Slope of Monocyte HLA-DR Expression Through Day 14
The recovery slope will be estimated using a linear mixed-effects model based on monocyte HLA-DR median fluorescence intensity (MFI) measured at baseline and Days 3, 7, and 14. Monocyte HLA-DR expression will be assessed by standardized multiparametric flow cytometry. The slope will be expressed as change in MFI per day.
Measured: Baseline and Days 3, 7, and 14.
Recovery Slope of Absolute Lymphocyte Count Through Day 14
The recovery slope of absolute lymphocyte count will be estimated using a linear mixed-effects model based on absolute lymphocyte counts obtained from routine complete blood count measurements at baseline and Days 3, 7, and 14. The slope will be expressed as change in ×10⁹/L per day.
Measured: Baseline and Days 3, 7, and 14
Change From Baseline in PD-1 Expression on CD8-Positive T Cells at Day 7
PD-1 expression on CD8-positive T cells will be assessed by standardized multiparametric flow cytometry and reported as median fluorescence intensity (MFI). Change will be calculated as the Day 7 MFI minus the baseline MFI.
Measured: Baseline (Day 0) and Day 7
Absolute Natural Killer Cell Count at Baseline and Day 7
Absolute natural killer (NK) cell counts will be assessed at baseline and Day 7 and reported as ×10⁹/L.
Measured: Baseline (Day 0) and Day 7
Reduction From Baseline in Sequential Organ Failure Assessment Score Through Day 14
The Sequential Organ Failure Assessment (SOFA) score will be assessed at baseline and Days 3, 7, and 14. Reduction will be calculated as the baseline score minus the score at each follow-up assessment. Total scores range from 0 to 24; higher scores indicate more severe organ dysfunction. A positive reduction indicates improvement.
Measured: Baseline and Days 3, 7, and 14
Mechanical Ventilation-Free Days Through Day 28
Number of days without mechanical ventilation from randomization through Day 28.
Measured: From randomization through Day 28
Vasopressor-Free Days Through Day 28
Number of days without vasopressor therapy from randomization through Day 28.
Measured: From randomization through Day 28
Renal Replacement Therapy-Free Days Through Day 28
Number of days without continuous renal replacement therapy (CRRT) from randomization through Day 28.
Measured: From randomization through Day 28
All-Cause Mortality During the Index ICU Stay
Percentage of participants who die from any cause during the index ICU stay after enrollment. This outcome is exploratory.
Measured: From enrollment until ICU discharge or death, up to Day 90
All-Cause Mortality During the Index Hospitalization
Percentage of participants who die from any cause during the index hospitalization after enrollment. This outcome is exploratory.
Measured: From enrollment until hospital discharge or death, up to Day 90
All-Cause Mortality Within 28 Days After Randomization
Percentage of participants who die from any cause within 28 days after randomization. This is an exploratory outcome; the trial is sized for the primary immunological outcome rather than a definitive mortality comparison.
Measured: From randomization through Day 28
All-Cause Mortality Within 90 Days After Randomization
Percentage of participants who die from any cause within 90 days after randomization. This is an exploratory outcome; the trial is sized for the primary immunological outcome rather than a definitive mortality comparison.
Measured: From randomization through Day 90
Participants With at Least One Adverse Event
Percentage of participants experiencing at least one adverse event during the treatment and follow-up periods. Adverse event severity will be graded using CTCAE version 5.0, and events will be coded using MedDRA.
Measured: From enrollment through Day 90
Participants With at Least One Serious Adverse Event
Percentage of participants experiencing at least one serious adverse event during the study period, as defined in the study protocol.
Measured: From enrollment through Day 90
Participants With a Thymalfasin-Related Adverse Event
Percentage of participants receiving thymalfasin who experience at least one adverse event judged by the investigator to be related to the study drug.
Measured: From the first study-drug dose through Day 90
Participants With an Injection-Site Reaction
Percentage of participants receiving thymalfasin who experience at least one local injection-site reaction during the 7-day study-drug treatment period.
Measured: From the first dose through Day 7
NKp46 Expression on Natural Killer Cells at Baseline and Day 7
NKp46 expression on natural killer (NK) cells will be assessed by standardized multiparametric flow cytometry and reported as median fluorescence intensity (MFI) at baseline and Day 7.
Measured: Baseline (Day 0) and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start6 Oct 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
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 Shanghai Zhongshan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongyu He, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866118
- Sponsor's protocol ID
- ZSICU-RAISE
- Acronym
- RAISE
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data outside the study team. Aggregate findings will be disseminated through scientific publications and presentations. Any future proposal for external sharing of de-identified participant data will be subject to institutional and ethics review and an appropriate consent and data-governance basis.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Mechanism Study of Thymosin Alpha-1 in Reshaping the "Immune Resilience" Trajectory of Immunosuppressed Sepsis Patients
- ClinicalTrials.gov ID
- NCT07866118
- Acronym / sponsor ID
- RAISE / ZSICU-RAISE
- Conditions
- Sepsis, Immunosuppression
- Keywords
- Thymalfasin, Thymosin alpha-1, Monocyte HLA-DR, Immune resilience, Immunoparalysis, T-cell exhaustion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 6 Oct 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 8 Oct 2026 (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 illness caused by an abnormal response to infection. Some people with sepsis have reduced immune function, which may make recovery more difficult. This study will examine whether adding thymalfasin, also called thymosin alpha-1, to usual sepsis care improves recovery of immune function.
The study will enroll 60 adults with sepsis and evidence of reduced immune function at Zhongshan Hospital, Fudan University. Participants will be assigned by chance to one of two groups. Thirty participants will receive usual care plus a 1.6 mg thymalfasin injection under the skin twice daily for 7 days. Thirty participants will receive usual care alone, without study-drug or placebo injections.
Participants and treating clinicians will know which treatment is given, but laboratory staff measuring immune outcomes will not know the assigned group. The main outcome is the change in monocyte HLA-DR expression, a blood marker of immune function, between baseline and Day 7. Other assessments include immune cells, organ function, organ support, infections, survival, and safety. Scheduled follow-up continues through Day 90. The study is designed primarily to assess an immune marker; it is not sized to establish a definitive survival benefit.
Detailed description
This investigator-initiated, single-center, prospective, randomized, controlled exploratory study will evaluate thymalfasin in adults with sepsis and an immunosuppressed phenotype. The study will be conducted in the Department of Critical Care Medicine at Zhongshan Hospital, Fudan University.
Eligible participants will meet Sepsis-3 criteria, have an Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 15 to 30 at ICU admission, and meet the protocol-defined monocyte HLA-DR eligibility criterion. Enrollment must occur within 48 hours of sepsis onset. Written informed consent will be obtained from the participant or a legally authorized representative.
Sixty participants will be randomized in a 1:1 ratio. The experimental group will receive standard sepsis care plus thymalfasin 1.6 mg subcutaneously twice daily, approximately 12 hours apart, for 7 consecutive days. The control group will receive standard sepsis care alone. Standard care will be determined by the treating clinicians and may include infection source control, antimicrobial therapy, fluid resuscitation, vasopressors, and organ support as clinically indicated.
The primary outcome is the change in monocyte HLA-DR expression from baseline before randomization to Day 7. Expression will be assessed by flow cytometry using Panel 1 of the six-panel immunophenotyping method and summarized as the median HLA-DR fluorescence intensity within the prespecified monocyte population. Full-panel immune assessments are scheduled at baseline and Day 7, with core assessments at Days 1, 3, and 14. The protocol specifies immune recovery slopes using measurements at baseline and Days 3, 7, and 14. Samples will be coded, and laboratory personnel will be blinded to treatment allocation.
Secondary assessments will characterize immune recovery, T-cell phenotypes, natural killer cells, organ dysfunction, organ support, and survival. Mortality comparisons are exploratory because the sample size is based on the primary immunological outcome. Safety events will be assessed during the protocol-defined monitoring period. Scheduled survival follow-up continues through Day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymalfasin Plus Standard Care | Experimental | Drug: Thymalfasin (Thymosin alpha 1, Ta1)Participants will receive standard sepsis care plus thymalfasin 1.6 mg subcutaneously twice daily, approximately 12 hours apart, for 7 consecutive days (Days 1 to 7). Thirty participants are planned for this arm. |
| Standard Care Alone | No intervention | –Participants will receive standard sepsis care determined by the treating clinicians, including infection source control, antimicrobial therapy, fluid resuscitation, vasopressors, and organ support as clinically indicated. No thymalfasin or placebo injections will be given as study interventions. Thirty participants are planned for this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age older than 18 years, of any sex. Sepsis according to Sepsis-3 criteria, defined as documented or suspected infection with an increase in Sequential Organ Failure Assessment (SOFA) score of at least 2 points from baseline.
- APACHE II score of 15 to 30, inclusive, at ICU admission. An immunosuppressed phenotype, defined by reduced monocyte HLA-DR expression meeting No more than 48 hours from sepsis onset to enrollment. Written informed consent provided by the participant or legally authorized representative.
Key exclusion criteria (5 listed)
- Known allergy to thymalfasin or any of its excipients. A history of primary or acquired immunodeficiency, such as HIV infection or post-transplant immunosuppression.
- Treatment with immunosuppressive agents or immunostimulants within 3 months before enrollment, including systemic corticosteroids at a prednisone-equivalent dose greater than 20 mg/day for at least 7 consecutive days, cyclosporine, tacrolimus, or azathioprine.
- Active malignancy or ongoing anticancer treatment. Chronic liver disease classified as Child-Pugh class C, or end-stage renal disease requiring maintenance dialysis.
- Pregnancy or breastfeeding. Expected survival of less than 48 hours at enrollment, such as irreversible brain death after cardiac arrest or terminal multiple organ failure.
- Concurrent participation in another interventional clinical trial. Any other condition that, in the investigator's judgment, makes participation unsuitable.
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 |
|---|---|---|
| Thymalfasin (Thymosin alpha 1, Ta1)Thymalfasin lyophilized powder for injection, 1.6 mg per vial, will be reconstituted with 1 mL of 0.9% sodium chloride and administered subcutaneously at a dose of 1.6 mg twice daily, approximately 12 hours apart, for 7 consecutive days. Injection sites will be rotated between the upper arm and abdomen. | Drug | Thymalfasin Plus Standard Care |
Primary outcome
Change From Baseline in Monocyte HLA-DR Expression at Day 7
Time frame: Baseline (Day 0, before randomization) and Day 7
Monocyte HLA-DR expression will be assessed by standardized multiparametric flow cytometry according to the six-panel immunophenotyping method and reported as median fluorescence intensity (MFI). Change will be calculated as the Day 7 MFI minus the baseline MFI measured before randomization. A positive change indicates increased monocyte HLA-DR expression.
17 secondary outcomes
Recovery Slope of Monocyte HLA-DR Expression Through Day 14
Time frame: Baseline and Days 3, 7, and 14.
Recovery Slope of Absolute Lymphocyte Count Through Day 14
Time frame: Baseline and Days 3, 7, and 14
Change From Baseline in PD-1 Expression on CD8-Positive T Cells at Day 7
Time frame: Baseline (Day 0) and Day 7
Absolute Natural Killer Cell Count at Baseline and Day 7
Time frame: Baseline (Day 0) and Day 7
Reduction From Baseline in Sequential Organ Failure Assessment Score Through Day 14
Time frame: Baseline and Days 3, 7, and 14
Mechanical Ventilation-Free Days Through Day 28
Time frame: From randomization through Day 28
Vasopressor-Free Days Through Day 28
Time frame: From randomization through Day 28
Renal Replacement Therapy-Free Days Through Day 28
Time frame: From randomization through Day 28
All-Cause Mortality During the Index ICU Stay
Time frame: From enrollment until ICU discharge or death, up to Day 90
All-Cause Mortality During the Index Hospitalization
Time frame: From enrollment until hospital discharge or death, up to Day 90
All-Cause Mortality Within 28 Days After Randomization
Time frame: From randomization through Day 28
All-Cause Mortality Within 90 Days After Randomization
Time frame: From randomization through Day 90
Participants With at Least One Adverse Event
Time frame: From enrollment through Day 90
Participants With at Least One Serious Adverse Event
Time frame: From enrollment through Day 90
Participants With a Thymalfasin-Related Adverse Event
Time frame: From the first study-drug dose through Day 90
Participants With an Injection-Site Reaction
Time frame: From the first dose through Day 7
NKp46 Expression on Natural Killer Cells at Baseline and Day 7
Time frame: Baseline (Day 0) and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data outside the study team. Aggregate findings will be disseminated through scientific publications and presentations. Any future proposal for external sharing of de-identified participant data will be subject to institutional and ethics review and an appropriate consent and data-governance basis.
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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.
Hongyu He principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymalfasin (Thymosin alpha 1, Ta1) in people with Sepsis and Immunosuppression, run by Shanghai Zhongshan 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongyu He, PHD (13564155433, he.hongyu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Monocyte HLA-DR Expression at Day 7 (time frame: Baseline (Day 0, before randomization) and Day 7). 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 8 Oct 2026.