SepsisPhase 2CEMVISNCT05194189
Clinical Efficacy of Megadose Vitamin C in Sepsis
A Phase 2 study testing Vitamin C and 5% glucose injection in people with Sepsis and Septic Shock, run by Zhujiang Hospital at 4 sites in China.
Trial summary
In this multicenter, randomized, single-blind, placebo-controlled clinical trial. Patients will be randomly assigned to receive Vitamin C or placebo for 4 days or until ICU discharge (whatever come first). The primary outcome is 28-day all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Vitamin C and 5% glucose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 4 sitesChina
- Study dates
- 8 Feb 2022to 25 Dec 2024
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for sepsis-3 developed by the American Society of Critical Care Medicine (SCCM)/European Critical Care Medicine Association (ESICM)
- Age ≥18 years old and age ≤80 years old.
- Procalcitonin ≥2 ng/ml
Who cannot join
- Age<18 years, or age>80 years.
- Pregnancy or lactating
- A solid-organ or bone marrow transplant patients.
- Patients with myocardial infarction within the past 3 months.
- Advanced pulmonary fibrosis .
- Patients with cardiopulmonary resuscitation before enrollment.
Show all 16Show fewer
- HIV-positive patients.
- granulocyte-deficient patients.
- blood/lymphatic system tumors are not remission.
- patients with limited care (lack of commitment to full aggressive life support).
- patients with long-term use of immunosuppressive drugs or with immunodeficiency.
- patients with advanced tumors.
- patients combined with non-infectious factors leading to the death(uncontrollable major bleeding, brain hernia, etc.).
- surgically unresolved infection sources(such as some intraperitoneal infection etc.)
- patients allergic to vitamin c.
- patients with G6PD deficiency.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guanzhou, Guangdong
Department of Critical Care Medicine of Nanfang Hospital of Southern Medical University
Guanzhou
Department of Critical Care Medicine of Yunfu People's Hospital
Yunfu, Guangdong, 527300
Department of Critical Care Medicine of Zhongshan People's Hospital
Zhongshan, Guangzhou, 528403
About this study
Official title: Clinical Efficacy of Megadose Vitamin C in Sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
In this multicenter, randomized, single-blind, placebo-controlled clinical trial. Patients will be randomly assigned to receive Vitamin C or placebo for 4 days or until ICU discharge (whatever come first). The primary outcome is 28-day all-cause mortality.
Read the detailed description
Investigational drug: Vitamin C for injection
Study title: Clinical efficacy of megadose vitamin C in sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Principal Investigator: Zhanguo Liu, professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University
Study subjects: Adult septic/septic shock patients with procalcitonin(PCT)≥2ng/ml at recruitment.
Study phase: Investigator Initiated Trial(IIT)
Study objectives: The objective of the study is to determine whether megadose vitamin c, compared to placebo, improve the prognosis of sepsis, including the reduction in mortality, the protection of organ function and reduction of inflammatory response, and to determine the safety of megadose vitamin c in patients with sepsis.
Study design: A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Method： Megadose vitamin C group: routine treatment follow the recommendation of the guidelines for sepsis in 2021+ 12 g vitamin C (48 ml) injection every 12 h for 4 days or until ICU discharge (death or transfer from ICU to general ward or discharge), whatever come first. Placebo control group: routine treatment follow the recommendation of the guidelines for sepsis in 2021 + 48ml 5% glucose injection every 12 h for 4 days or until ICU discharge (death or transfer from ICU to general ward or discharge), whatever come first.
Course: 4 days
Sample size: 234
The number of study center: 4
Study center:
- Department of Critical Care Medicine of Zhujiang Hospital,Guangzhou, Guangdong, China
- Department of Critical Care Medicine of Yunfu People' s Hospital, Yunfu, Guangdong, China
- Department of Critical Care Medicine of Zhongshan People's Hospital, Zhongshan, Guangdong, China
- Department of Critical Care Medicine of Nanfang Hospital,Guangzhou, Guangdong, China
Primary endpoint: 28-day all-cause mortality.
Secondary endpoints:
- The state of liver function: the serum level of transaminase(AST、ALT)、total bilirubin at 96 h after randomization
- The state of lung function: oxygenation index(PaO2/FiO2) at 96h after randomization
- The state of kidney function: serum level of Creatinine (Cr)、blood urea nitrogen(BUN)、Cystatin(Cys) at 96 h after randomization
- The state of inflammatory response: the serum level of interleukin-6(IL-6) and C-reactive protein(CRP) at 96 h after randomization.
- The state of infection: the serum level of procalcitonin(PCT) and white blood cell （WBC） at 96 h after randomization.
- The state of circulation system: the serum level of lactate at 96 h after randomization
- Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 96 h after randomization
- The duration of successful cessation of supportive therapies for organ dysfunction including vasoactive agents, mechanical ventilation.
- The duration of continuous renal replacement therapy(CRRT)
- The length of stay in ICU
Safety endpoints：
- adverse events
- Serious adverse events
- Conditions
- Sepsis, Septic Shock
- Being tested
- Vitamin C, 5% glucose injection
- Keywords
- megadose vitamin C
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
12 g vitamin C (48 ml) will be intravenously injected by a infusion pump every 12 h for 4 days or at ICU discharge
5% glucose injectionDrug
5% glucose solution 48 ml every 12 h for 4 days or at ICU discharge.
| Study group | Role | What they receive |
|---|---|---|
| Megadose vitamin C group | Experimental | 12 g vitamin C (48 ml) will intravenously injected by a infusion pump every 12 h for 4 days or until ICU discharge Receives: Drug: Vitamin C |
| Placebo group | Placebo comparator | 5% glucose solution 48 ml every 12 h for 4 days or until ICU discharge. Receives: Drug: 5% glucose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
All-cause mortality from the enrollment to the 28th days
Measured: The outcome will be assessed at the 28 day after enrollment
Secondary outcomes (17)
liver function(1)
the serum level of Alanine transaminase(ALT)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
liver function(2)
the serum level of Aspartate transaminase (AST)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
liver function(3)
the serum level of total bilirubin
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
lung function
oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator.
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(1)
serum level of Creatinine (Cr)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(2)
serum level of blood urea nitrogen(BUN)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(3)
serum level of Cystatin(Cys)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
inflammatory response(1)
the serum level of interleukin-6(IL-6)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
inflammatory response(2)
the serum level of C-reactive protein(CRP)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Indicators of infection(1)
the serum level of procalcitonin(PCT)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Indicators of infection(2)
the level of white blood cell count(WBC)
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
The level of lactate
the serum level of lactic acid
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Sequential Organ Failure Assessment (SOFA) score
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score. SOFA score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The highest score for each of the six items is 4 points, and the lowest score is 0 points. Finally, the scores of the six items are summed to get the value of the sofa score. The range of the sofa score is 0-24.Higher values represent a worse outcome.
Measured: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
The cessation of mechanical ventilation(MV) administration
The duration from the MV administration to the successful cessation in hours( The successful cessation is defined as the termination of MV for more than 48-hours. This outcome measure is intended only for patients receiving MV)
Measured: The outcome will be assessed at the 28 day after enrollment
The cessation of vasoactive drugs administration
The duration from the vasoactive drugs administration to the successful cessation in hours( The successful cessation is defined as the attainment of a clinician-prescribed mean arterial pressure target for more than 24-hours without the use of vasoactive drugs.This outcome measure is intended only for patients receiving vasoactive drugs)
Measured: The outcome will be assessed at the 28 day after enrollment
The duration of CRRT
The duration of CRRT therapy in hours( This outcome measure is intended only for patients receiving CRRT)
Measured: The outcome will be assessed at the 28 day after enrollment
ICU length of stay
ICU length of stay
Measured: The outcome will be assessed at the 28 day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start8 Feb 2022
- Primary completion4 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Zhujiang 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants in treatment group receive intravenous megadose vitamin C. The participants in control group receive 5% glucose injection with same volume.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
- Investigators
- Zhanguo Liu, M.D.PhD, Principal investigator, Department of Critical Care Medicine of Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194189
- Sponsor's protocol ID
- 2020-KY-069-05
- Acronym
- CEMVIS
- Status last verified
- May 2026
- First submitted
- 3 Jan 2022
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
Publications
Wang, G., Liang, Z., Guan, J. et al. Clinical Efficacy of Megadose Vitamin C in Sepsis: Protocol for a Multicenter Randomized Single-Blind Placebo-Controlled Clinical Trial. Intensive Care Res 4, 129-136 (2024). https://doi.org/10.1007/s44231-024-00066-7
Liu F, Zhu Y, Zhang J, Li Y, Peng Z. Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Jul 8;10(7):e039519. doi: 10.1136/bmjopen-2020-039519.
PubMed 32641343Chang P, Liao Y, Guan J, Guo Y, Zhao M, Hu J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z. Combined Treatment With Hydrocortisone, Vitamin C, and Thiamine for Sepsis and Septic Shock: A Randomized Controlled Trial. Chest. 2020 Jul;158(1):174-182. doi: 10.1016/j.chest.2020.02.065. Epub 2020 Mar 31.
PubMed 32243943
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Megadose Vitamin C in Sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05194189
- Acronym / sponsor ID
- CEMVIS / 2020-KY-069-05
- Conditions
- Sepsis, Septic Shock
- Keywords
- megadose vitamin C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 18 Jan 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.
In this multicenter, randomized, single-blind, placebo-controlled clinical trial. Patients will be randomly assigned to receive Vitamin C or placebo for 4 days or until ICU discharge (whatever come first). The primary outcome is 28-day all-cause mortality.
Detailed description
Investigational drug: Vitamin C for injection
Study title: Clinical efficacy of megadose vitamin C in sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Principal Investigator: Zhanguo Liu, professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University
Study subjects: Adult septic/septic shock patients with procalcitonin(PCT)≥2ng/ml at recruitment.
Study phase: Investigator Initiated Trial(IIT)
Study objectives: The objective of the study is to determine whether megadose vitamin c, compared to placebo, improve the prognosis of sepsis, including the reduction in mortality, the protection of organ function and reduction of inflammatory response, and to determine the safety of megadose vitamin c in patients with sepsis.
Study design: A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Method： Megadose vitamin C group: routine treatment follow the recommendation of the guidelines for sepsis in 2021+ 12 g vitamin C (48 ml) injection every 12 h for 4 days or until ICU discharge (death or transfer from ICU to general ward or discharge), whatever come first. Placebo control group: routine treatment follow the recommendation of the guidelines for sepsis in 2021 + 48ml 5% glucose injection every 12 h for 4 days or until ICU discharge (death or transfer from ICU to general ward or discharge), whatever come first.
Course: 4 days
Sample size: 234
The number of study center: 4
Study center:
- Department of Critical Care Medicine of Zhujiang Hospital,Guangzhou, Guangdong, China
- Department of Critical Care Medicine of Yunfu People' s Hospital, Yunfu, Guangdong, China
- Department of Critical Care Medicine of Zhongshan People's Hospital, Zhongshan, Guangdong, China
- Department of Critical Care Medicine of Nanfang Hospital,Guangzhou, Guangdong, China
Primary endpoint: 28-day all-cause mortality.
Secondary endpoints:
- The state of liver function: the serum level of transaminase(AST、ALT)、total bilirubin at 96 h after randomization
- The state of lung function: oxygenation index(PaO2/FiO2) at 96h after randomization
- The state of kidney function: serum level of Creatinine (Cr)、blood urea nitrogen(BUN)、Cystatin(Cys) at 96 h after randomization
- The state of inflammatory response: the serum level of interleukin-6(IL-6) and C-reactive protein(CRP) at 96 h after randomization.
- The state of infection: the serum level of procalcitonin(PCT) and white blood cell （WBC） at 96 h after randomization.
- The state of circulation system: the serum level of lactate at 96 h after randomization
- Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 96 h after randomization
- The duration of successful cessation of supportive therapies for organ dysfunction including vasoactive agents, mechanical ventilation.
- The duration of continuous renal replacement therapy(CRRT)
- The length of stay in ICU
Safety endpoints：
- adverse events
- Serious adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants in treatment group receive intravenous megadose vitamin C. The participants in control group receive 5% glucose injection with same volume.
| Arm | Type | Receives |
|---|---|---|
| Megadose vitamin C group | Experimental | Drug: Vitamin C12 g vitamin C (48 ml) will intravenously injected by a infusion pump every 12 h for 4 days or until ICU discharge |
| Placebo group | Placebo comparator | Drug: 5% glucose injection5% glucose solution 48 ml every 12 h for 4 days or until ICU discharge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets the diagnostic criteria for sepsis-3 developed by the American Society of Critical Care Medicine (SCCM)/European Critical Care Medicine Association (ESICM)
- Age ≥18 years old and age ≤80 years old.
- Procalcitonin ≥2 ng/ml
Key exclusion criteria (16 listed)
- Age<18 years, or age>80 years.
- Pregnancy or lactating
- A solid-organ or bone marrow transplant patients.
- Patients with myocardial infarction within the past 3 months.
- Advanced pulmonary fibrosis .
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 |
|---|---|---|
| Vitamin C12 g vitamin C (48 ml) will be intravenously injected by a infusion pump every 12 h for 4 days or at ICU discharge | Drug | Megadose vitamin C group |
| 5% glucose injection5% glucose solution 48 ml every 12 h for 4 days or at ICU discharge. | Drug | Placebo group |
Primary outcome
28-day all-cause mortality
Time frame: The outcome will be assessed at the 28 day after enrollment
All-cause mortality from the enrollment to the 28th days
17 secondary outcomes
liver function(1)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
liver function(2)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
liver function(3)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
lung function
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(1)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(2)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(3)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
inflammatory response(1)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
inflammatory response(2)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Indicators of infection(1)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Indicators of infection(2)
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
The level of lactate
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Sequential Organ Failure Assessment (SOFA) score
Time frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
The cessation of mechanical ventilation(MV) administration
Time frame: The outcome will be assessed at the 28 day after enrollment
The cessation of vasoactive drugs administration
Time frame: The outcome will be assessed at the 28 day after enrollment
The duration of CRRT
Time frame: The outcome will be assessed at the 28 day after enrollment
ICU length of stay
Time frame: The outcome will be assessed at the 28 day after enrollment
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 13 May 2026.
- BackgroundWang, G., Liang, Z., Guan, J. et al. Clinical Efficacy of Megadose Vitamin C in Sepsis: Protocol for a Multicenter Randomized Single-Blind Placebo-Controlled Clinical Trial. Intensive Care Res 4, 129-136 (2024). https://doi.org/10.1007/s44231-024-00066-7
- Background: PubMed 32641343Liu F, Zhu Y, Zhang J, Li Y, Peng Z. Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Jul 8;10(7):e039519. doi: 10.1136/bmjopen-2020-039519.
- Background: PubMed 32243943Chang P, Liao Y, Guan J, Guo Y, Zhao M, Hu J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z. Combined Treatment With Hydrocortisone, Vitamin C, and Thiamine for Sepsis and Septic Shock: A Randomized Controlled Trial. Chest. 2020 Jul;158(1):174-182. doi: 10.1016/j.chest.2020.02.065. Epub 2020 Mar 31.
- study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
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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.
Zhanguo Liu, M.D.PhD principal investigator
Department of Critical Care Medicine of Zhujiang Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C and 5% glucose injection in people with Sepsis and Septic Shock, run by Zhujiang Hospital at 4 sites 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 3 inclusion and 16 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 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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 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?
28-day all-cause mortality (time frame: The outcome will be assessed at the 28 day after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194189, which also lists 3 linked publications.
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 13 May 2026.