Septic ShockNCT06749756
Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
A study testing vitamin B6+ Vitamin B12 +vitamin C, vitamin B6+ Vitamin B12 and vitamin C in people with Septic Shock, run by Fan Zeng at 1 site in China.
Trial summary
Sepsis is a kind of disease with high morbidity and mortality in ICU. At present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress. Anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin B6, vitamin B12 and vitamin C… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- vitamin B6+ Vitamin B12 +vitamin C, vitamin B6+ Vitamin B12 and vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 28 Feb 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and < 85 years old
- Admitted to ICU
- Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points
- 5. Obtain the informed consent of the subject or his family
Who cannot join
- Patients have absolute contraindications such as vitamin allergy
- Patients with a history of gout
- Death is expected within 24 hours
- Pregnant women
- Use hydroprednisone or other equivalent dose hormones > 200mg/d within 24 hours
- Without the informed consent of the patient or his/her representative
Show all 10Show fewer
- Patients with a history of scleroderma
- Patients with a history of vasculitis
- Patients with oral mucosal diseases
- Patients with severe difficulty in opening their mouth and unable to detect sublingual microcirculation
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
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610031
fan Zeng, Learned scholar, 17744339835, zengfan1985@126.com
qin Xu, 13458134030, 2246062995@qq.com
About this study
Sepsis is a kind of disease with high morbidity and mortality in ICU. At present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress. Anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin B6, vitamin B12 and vitamin C have anti-inflammatory, antioxidant and immune-regulating effects. The purpose of this study was to investigate whether vitamin B6, vitamin B12 combined with vitamin C can improve the microcirculation and organ dysfunction in patients with sepsis, and improve the survival rate of patients with sepsis. The study included 296 patients who met the inclusion criteria. After randomization, the experimental group was given intravenous vitamin B6 300mg qd in addition to the basic treatment of sepsis Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. Control group 1 was given vitamin B6 300mg qd and vitamin B12 0.5mg q6h intravenously for 4 days. Control group 2 was injected with vitamin C 50mg/kg q6h intravenously for 4 days. Control group 3: The same dose of placebo (0.9% sodium chloride solution) was administered for 4 days. After medication, sublingual microcirculation image and radial artery resistance index of snus pit were detected and recorded according to the time required by the study protocol. The duration of use of pressor drugs, ventilator days, ICU stay, 28-day mortality, capillary refill time, changes in SOFA score and APACHEII score on day 3 and day 7 compared with baseline values at randomization, daily veno-arterial carbon dioxide differential pressure (GAP) and central venous oxygen saturation were recorded. After the end of the experiment, statistical analysis of the data was carried out to further explore the test results
- Conditions
- Septic Shock
- Being tested
- vitamin B6+ Vitamin B12 +vitamin C, vitamin B6+ Vitamin B12, vitamin C, 0.9%Nacl
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin B6+ Vitamin B12 +vitamin CDrug
In addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days.
vitamin B6+ Vitamin B12Drug
In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days.
vitamin CDrug
On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days.
0.9%NaclDrug
The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. Receives: Drug: vitamin B6+ Vitamin B12 +vitamin C |
| Control group 1 | Active comparator | In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days. Receives: Drug: vitamin B6+ Vitamin B12 |
| Control group 2 | Active comparator | On the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days. Receives: Drug: vitamin C |
| Control group 3 | Active comparator | The same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days. Receives: Drug: 0.9%Nacl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of microcirculation
Sublingual microcirculation index (including perfusion vessel density (PVD) and total vessel density (TVD)) was measured after initiation of administration.
Measured: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
Improvement of microcirculation
The radial artery resistance index of snus pit was measured after the start of administration.
Measured: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
Secondary outcomes (9)
The duration of the patient's use of pressor drugs
Duration of pressor drug use during the patient's trial medication
Measured: 4 days
Number of days on ventilator
The number of days the patient was ventilator-ventilated within 28 days
Measured: 28 days
ICU stay
Patient's 28-day ICU stay
Measured: 28 days
28-day mortality
28-day mortality
Measured: 28 days
Capillary refill time
Capillary refill time during trial medication
Measured: 4 days
Changes in SOFA score
Changes in SOFA scores on day 3 and day 7 compared with baseline values at randomization.The SOFA Score (Sequential Organ Failure Assessment Score) is a scoring system used to assess the severity of organ dysfunction in critically ill patients. It consists of six systems: respiratory, blood, liver, cardiovascular, nervous and kidney, with each system scored according to the degree of dysfunction on a scale of 0 (normal) to 4 (severe impairment or failure). The score of SOFA is closely related to the mortality and prognosis of patients. The higher the score, the higher the mortality.
Measured: 7 days
Changes in APACHEII score
Changes in APACHEII scores on day 3 and day 7 compared with baseline values at randomization.The Apache II score, also known as the Acute Physiological and Chronic Health Assessment (APACHE II), is a scoring system used to assess the severity of a critically ill patient's condition and predict prognosis. The theoretical maximum value is 71 points, and the higher the score, the more severe the disease, the worse the prognosis and the higher the fatality rate.
Measured: 7 days
Daily change of veno-arterial carbon dioxide differential pressure (GAP)
Daily change of veno-arterial carbon dioxide differential pressure (GAP)
Measured: 4 days
Daily change of central venous oxygen saturation (Scv02)
Daily change of central venous oxygen saturation (Scv02)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start10 Feb 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fan Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fan Zeng, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749756
- Sponsor's protocol ID
- No. 742-1in2024ofLunShen(Yan）
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wald EL, Badke CM, Hintz LK, Spewak M, Sanchez-Pinto LN. Vitamin therapy in sepsis. Pediatr Res. 2022 Jan;91(2):328-336. doi: 10.1038/s41390-021-01673-6. Epub 2021 Jul 31.
PubMed 34333556Giustina AD, Danielski LG, Novochadlo MM, Goldim MPS, Joaquim L, Metzker KLL, Carli RJ, Denicol T, Cidreira T, Vieira T, Petronilho F. Vitamin B6 reduces oxidative stress in lungs and liver in experimental sepsis. An Acad Bras Cienc. 2019 Dec 2;91(4):e20190434. doi: 10.1590/0001-3765201920190434. eCollection 2019.
PubMed 31800708Wang Y, Lu WL, Feng WM, Xu W, Liu LH, He LM. RENAL PROTECTIVE EFFECT AND CLINICAL ANALYSIS OF VITAMIN B 6 IN PATIENTS WITH SEPSIS. Shock. 2024 Jun 1;61(6):841-847. doi: 10.1097/SHK.0000000000002329. Epub 2024 Apr 26.
PubMed 38691102Zhao W, Zhang J, Lu Y, Wang R. The vasorelaxant effect of H(2)S as a novel endogenous gaseous K(ATP) channel opener. EMBO J. 2001 Nov 1;20(21):6008-16. doi: 10.1093/emboj/20.21.6008.
PubMed 11689441Patel JJ, Willoughby R, Peterson J, Carver T, Zelten J, Markiewicz A, Spiegelhoff K, Hipp LA, Canales B, Szabo A, Heyland DK, Stoppe C, Zielonka J, Freed JK. High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The Intravenous Hydroxocobalamin in Septic Shock Trial). Chest. 2023 Feb;163(2):303-312. doi: 10.1016/j.chest.2022.09.021. Epub 2022 Sep 26.
PubMed 36174744Fisher BJ, Seropian IM, Kraskauskas D, Thakkar JN, Voelkel NF, Fowler AA 3rd, Natarajan R. Ascorbic acid attenuates lipopolysaccharide-induced acute lung injury. Crit Care Med. 2011 Jun;39(6):1454-60. doi: 10.1097/CCM.0b013e3182120cb8.
PubMed 21358394Sevransky JE, Rothman RE, Hager DN, Bernard GR, Brown SM, Buchman TG, Busse LW, Coopersmith CM, DeWilde C, Ely EW, Eyzaguirre LM, Fowler AA, Gaieski DF, Gong MN, Hall A, Hinson JS, Hooper MH, Kelen GD, Khan A, Levine MA, Lewis RJ, Lindsell CJ, Marlin JS, McGlothlin A, Moore BL, Nugent KL, Nwosu S, Polito CC, Rice TW, Ricketts EP, Rudolph CC, Sanfilippo F, Viele K, Martin GS, Wright DW; VICTAS Investigators. Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):742-750. doi: 10.1001/jama.2020.24505.
PubMed 33620405
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C
- ClinicalTrials.gov ID
- NCT06749756
- Acronym / sponsor ID
- No. 742-1in2024ofLunShen(Yan）
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Fan ZengUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 27 Dec 2024 (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 kind of disease with high morbidity and mortality in ICU. At present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress. Anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin B6, vitamin B12 and vitamin C have anti-inflammatory, antioxidant and immune-regulating effects. The purpose of this study was to investigate whether vitamin B6, vitamin B12 combined with vitamin C can improve the microcirculation and organ dysfunction in patients with sepsis, and improve the survival rate of patients with sepsis. The study included 296 patients who met the inclusion criteria. After randomization, the experimental group was given intravenous vitamin B6 300mg qd in addition to the basic treatment of sepsis Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. Control group 1 was given vitamin B6 300mg qd and vitamin B12 0.5mg q6h intravenously for 4 days. Control group 2 was injected with vitamin C 50mg/kg q6h intravenously for 4 days. Control group 3: The same dose of placebo (0.9% sodium chloride solution) was administered for 4 days. After medication, sublingual microcirculation image and radial artery resistance index of snus pit were detected and recorded according to the time required by the study protocol. The duration of use of pressor drugs, ventilator days, ICU stay, 28-day mortality, capillary refill time, changes in SOFA score and APACHEII score on day 3 and day 7 compared with baseline values at randomization, daily veno-arterial carbon dioxide differential pressure (GAP) and central venous oxygen saturation were recorded. After the end of the experiment, statistical analysis of the data was carried out to further explore the test results
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: vitamin B6+ Vitamin B12 +vitamin CIn addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. |
| Control group 1 | Active comparator | Drug: vitamin B6+ Vitamin B12In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days. |
| Control group 2 | Active comparator | Drug: vitamin COn the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days. |
| Control group 3 | Active comparator | Drug: 0.9%NaclThe same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 and < 85 years old
- Admitted to ICU
- Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points
- 5. Obtain the informed consent of the subject or his family
Key exclusion criteria (10 listed)
- Patients have absolute contraindications such as vitamin allergy
- Patients with a history of gout
- Death is expected within 24 hours
- Pregnant women
- Use hydroprednisone or other equivalent dose hormones > 200mg/d within 24 hours
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 B6+ Vitamin B12 +vitamin CIn addition to the basic treatment of sepsis, intravenous injection of vitamin B6 300mg qd Vitamin B12 0.5mg q6h, vitamin C 50mg/kg q6h for 4 days. | Drug | Experimental group |
| vitamin B6+ Vitamin B12In addition to the basic treatment of sepsis, vitamin B6 300mg qd and vitamin B12 0.5mg q6h were given intravenously for 4 days. | Drug | Control group 1 |
| vitamin COn the basis of the basic treatment of sepsis, intravenous vitamin C 50mg/kg q6h was given for 4 days. | Drug | Control group 2 |
| 0.9%NaclThe same dose of placebo (0.9% sodium chloride solution) was administered on top of the sepsis base treatment for 4 days. | Drug | Control group 3 |
Primary outcome
Improvement of microcirculation
Time frame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
Sublingual microcirculation index (including perfusion vessel density (PVD) and total vessel density (TVD)) was measured after initiation of administration.
Improvement of microcirculation
Time frame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.
The radial artery resistance index of snus pit was measured after the start of administration.
9 secondary outcomes
The duration of the patient's use of pressor drugs
Time frame: 4 days
Number of days on ventilator
Time frame: 28 days
ICU stay
Time frame: 28 days
28-day mortality
Time frame: 28 days
Capillary refill time
Time frame: 4 days
Changes in SOFA score
Time frame: 7 days
Changes in APACHEII score
Time frame: 7 days
Daily change of veno-arterial carbon dioxide differential pressure (GAP)
Time frame: 4 days
Daily change of central venous oxygen saturation (Scv02)
Time frame: 4 days
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 5 Feb 2025.
- Results publication: PubMed 34333556Wald EL, Badke CM, Hintz LK, Spewak M, Sanchez-Pinto LN. Vitamin therapy in sepsis. Pediatr Res. 2022 Jan;91(2):328-336. doi: 10.1038/s41390-021-01673-6. Epub 2021 Jul 31.
- Results publication: PubMed 31800708Giustina AD, Danielski LG, Novochadlo MM, Goldim MPS, Joaquim L, Metzker KLL, Carli RJ, Denicol T, Cidreira T, Vieira T, Petronilho F. Vitamin B6 reduces oxidative stress in lungs and liver in experimental sepsis. An Acad Bras Cienc. 2019 Dec 2;91(4):e20190434. doi: 10.1590/0001-3765201920190434. eCollection 2019.
- Results publication: PubMed 38691102Wang Y, Lu WL, Feng WM, Xu W, Liu LH, He LM. RENAL PROTECTIVE EFFECT AND CLINICAL ANALYSIS OF VITAMIN B 6 IN PATIENTS WITH SEPSIS. Shock. 2024 Jun 1;61(6):841-847. doi: 10.1097/SHK.0000000000002329. Epub 2024 Apr 26.
- Results publication: PubMed 11689441Zhao W, Zhang J, Lu Y, Wang R. The vasorelaxant effect of H(2)S as a novel endogenous gaseous K(ATP) channel opener. EMBO J. 2001 Nov 1;20(21):6008-16. doi: 10.1093/emboj/20.21.6008.
- Results publication: PubMed 36174744Patel JJ, Willoughby R, Peterson J, Carver T, Zelten J, Markiewicz A, Spiegelhoff K, Hipp LA, Canales B, Szabo A, Heyland DK, Stoppe C, Zielonka J, Freed JK. High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The Intravenous Hydroxocobalamin in Septic Shock Trial). Chest. 2023 Feb;163(2):303-312. doi: 10.1016/j.chest.2022.09.021. Epub 2022 Sep 26.
- Results publication: PubMed 21358394Fisher BJ, Seropian IM, Kraskauskas D, Thakkar JN, Voelkel NF, Fowler AA 3rd, Natarajan R. Ascorbic acid attenuates lipopolysaccharide-induced acute lung injury. Crit Care Med. 2011 Jun;39(6):1454-60. doi: 10.1097/CCM.0b013e3182120cb8.
- Results publication: PubMed 33620405Sevransky JE, Rothman RE, Hager DN, Bernard GR, Brown SM, Buchman TG, Busse LW, Coopersmith CM, DeWilde C, Ely EW, Eyzaguirre LM, Fowler AA, Gaieski DF, Gong MN, Hall A, Hinson JS, Hooper MH, Kelen GD, Khan A, Levine MA, Lewis RJ, Lindsell CJ, Marlin JS, McGlothlin A, Moore BL, Nugent KL, Nwosu S, Polito CC, Rice TW, Ricketts EP, Rudolph CC, Sanfilippo F, Viele K, Martin GS, Wright DW; VICTAS Investigators. Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):742-750. doi: 10.1001/jama.2020.24505.
- Individual participant dataSharing planned: No
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Sepsis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin B6+ Vitamin B12 +vitamin C, vitamin B6+ Vitamin B12 and vitamin C in people with Septic Shock, run by Fan Zeng 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 10 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 5 Feb 2025. 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 fan Zeng (17744339835, zengfan1985@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of microcirculation (time frame: At 0 hour, 6hours, 24hours, 48hours, 4 days, and 7 days after initiation of administration.). The study lists 2 primary outcomes in all. 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 NCT06749756, which also lists 7 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 5 Feb 2025.