COVID-19 Vaccine Adverse ReactionPhase 4NCT06357104
Detoxification From the Lipid Tract
A Phase 4 study testing electroencephalogram biofeedback, electrical brain stimulation and ultra-low frequency transcranial magnetic stimulation in people with COVID-19 Vaccine Adverse Reaction, run by Pachankis, Yang I., M.D. at 1 site in China.
Trial summary
Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Vaccine Adverse Reaction
- What is being tested?
- electroencephalogram biofeedback, electrical brain stimulation and ultra-low frequency transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2024to 20 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who received full doses of COVID-19 vaccines.
Who cannot join
- Women during pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detoxification From the Lipid Tract by Cocktail Design
Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study.
Read the detailed description
It was tested that GABA, in the joint action with topiramate, modulates macrophage activities by modulating cholesterol-metabolism associated molecules. GABA A receptors exhibit highly dynamic trafficking and cell surface mobility and influence on post-endocytic effects. Benzodiazepines (BZDs) exercise the mechanism of action by facilitating the binding of the inhibitory neurotransmitter GABA at various GABA receptors throughout the central nervous system (CNS). Alprazolam, a type of BZD, was tested by Al-Tubuly, Aburawi, Alghzewi, Gorash and Errwami in joint action with water-soluble beta blocker atenolol, in comparison with the non-selective β-adrenoceptor antagonist propranolol on the pharmacological effects on depression. The study hypothesizes that by replacing the water-soluble beta blocker to lipid-soluble one metoprolol, the effect of detoxification from the lipid and sebaceous immunobiological pathways can be achieved by the clathrin-dependent endocytosis process.
Even though partial progress was made in the NCT05839236 trial by statin therapies, the therapeutic effects have not been lasting nor significant. The study develops from the previous protocol for a cocktail therapy by the joint mechanism of actions of alprazolam, metoprolol, and pravastatin sodium for the detoxification process.
- Conditions
- COVID-19 Vaccine Adverse Reaction
- Being tested
- electroencephalogram biofeedback, electrical brain stimulation, ultra-low frequency transcranial magnetic stimulation, Sertraline Hydrochloride, Clonazepam
- Keywords
- sebaceous immunobiology, lipid, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalogram biofeedbackDevice
Also called EB
EB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint.
electrical brain stimulationDevice
Also called EBS
EBS is conducted for 20 minutes per section per day in the primary efficacy endpoint.
ultra-low frequency transcranial magnetic stimulationDevice
Also called ULF-TMS
ULF-TMS is conducted mainly for the left side of the participant's brain for 20 minutes per section per day in the primary efficacy endpoint.
Sertraline HydrochlorideDrug
Also called SSRI
Sertraline is taken in the morning for 150 mg per day.
ClonazepamDrug
Clonazepam is taken in the morning for 1 mg per day.
AlprazolamDrug
Alprazolam is introduced near the end of the primary efficacy endpoint for 0.4 mg per night.
MetoprololDrug
Also called beta blocker
Metoprolol is introduced at the secondary efficacy endpoint starting with 47.5 mg per night and increase to 95 mg per night.
OlanzapineDrug
Olanzapine is taken throughout the trial with 7.5 mg per night at first, and increases to 10 mg per night after the cocktail therapy.
Pravastatin Sodium 20 MGDrug
Pravastatin sodium is introduced in the secondary efficacy endpoint with 20 mg per night.
Sacubitril Valsartan Sodium HydrateDrug
Also called ARNI
Sacubitril valsartan sodium is introduced in the secondary efficacy endpoint with 100 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| GABA Cocktail | Experimental | Not described Receives: Device: electroencephalogram biofeedback; Device: electrical brain stimulation; Device: ultra-low frequency transcranial magnetic stimulation; Drug: Sertraline Hydrochloride; Drug: Clonazepam; Drug: Alprazolam; Drug: Metoprolol; Drug: Olanzapine; Drug: Pravastatin Sodium 20 MG; Drug: Sacubitril Valsartan Sodium Hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Leukocyte and Components' Quantities
All white blood cells are evaluated.
Measured: 24 days
Changes in Leukocyte Components' Ratios
All white blood cells are evaluated.
Measured: 24 days
Quantity Changes in Megakaryocyte-Erythroid Progenitor
Measured: 24 days
Changes in Hemoglobin Distribution
Measured: 24 days
Changes in Mean Corpuscular Hemoglobin
Measured: 24 days
Changes in Hematocrit
Measured: 24 days
Changes in Plateletcrit
Measured: 24 days
Red cell Distribution Width Coefficient of Variation
Measured: 24 days
Changes in Particulate Matter Sizes
Measured: 24 days
Changes in Total Lipid Quantities
Measured: 24 days
Changes in Apolipoproteina
Measured: 24 days
Changes in Lipoprotein (a)
Measured: 24 days
Secondary outcomes (2)
Blood Pressure Changes
Recorded systolic and diastolic blood pressures' changes before and after medication each day.
Measured: 24 days
Heart Rate Changes
Heart rate changes before and after medication each day.
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start26 Feb 2024
- Primary completion14 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Vaccine Adverse ReactionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pachankis, Yang I., M.D.
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357104
- Sponsor's protocol ID
- SCI-CT-0001
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared on Zenodo repository.
Publications
Kim H, Nobeyama T, Honda S, Yasuda K, Morone N, Murakami T. Membrane fusogenic high-density lipoprotein nanoparticles. Biochim Biophys Acta Biomembr. 2019 Oct 1;1861(10):183008. doi: 10.1016/j.bbamem.2019.06.007. Epub 2019 Jun 15.
PubMed 31207206Zhao M, Luo Z, He H, Shen B, Liang J, Zhang J, Ye J, Xu Y, Wang Z, Ye D, Wang M, Wan J. Decreased Low-Density Lipoprotein Cholesterol Level Indicates Poor Prognosis of Severe and Critical COVID-19 Patients: A Retrospective, Single-Center Study. Front Med (Lausanne). 2021 May 26;8:585851. doi: 10.3389/fmed.2021.585851. eCollection 2021.
PubMed 34124081Glebov OO. Understanding SARS-CoV-2 endocytosis for COVID-19 drug repurposing. FEBS J. 2020 Sep;287(17):3664-3671. doi: 10.1111/febs.15369. Epub 2020 Jun 2.
PubMed 32428379Pachankis YI. Plausibility Review on Lipoprotein (A) Infection Path of S2 Autoimmune Pathogen. Global Journal of Medical Research. 2023;23(3)(C):5-11.
Yang Y, Lian YT, Huang SY, Yang Y, Cheng LX, Liu K. GABA and topiramate inhibit the formation of human macrophage-derived foam cells by modulating cholesterol-metabolism-associated molecules. Cell Physiol Biochem. 2014;33(4):1117-29. doi: 10.1159/000358681. Epub 2014 Apr 9.
PubMed 24733016Lombardi JP, Kinzlmaier DA, Jacob TC. Visualizing GABA A Receptor Trafficking Dynamics with Fluorogenic Protein Labeling. Curr Protoc Neurosci. 2020 Jun;92(1):e97. doi: 10.1002/cpns.97.
PubMed 32364672Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013 Summer;13(2):214-23.
PubMed 23789008Al-Tubuly R, Aburawi S, Alghzewi E, Gorash Z, Errwami S. The effect of sympathetic antagonists on the antidepressant action of alprazolam. Libyan J Med. 2008 Jun 1;3(2):78-83. doi: 10.4176/080101.
PubMed 21499463Hunninghake D, Wallace RB, Reiland S, Barrett-Connor E, Wahl P, Hoover J, Heiss G. Alterations of plasma lipid and lipoprotein levels associated with benzodiazepine use--the LRC Program Prevalence Study. Atherosclerosis. 1981 Oct;40(2):159-65. doi: 10.1016/0021-9150(81)90034-4.
PubMed 6118165McGrath M, Hoyt H, Pence A, Forman SA, Raines DE. Selective actions of benzodiazepines at the transmembrane anaesthetic binding sites of the GABAA receptor: In vitro and in vivo studies. Br J Pharmacol. 2021 Dec;178(24):4842-4858. doi: 10.1111/bph.15662. Epub 2021 Sep 26.
PubMed 34386973Mascarenhas FNADP, Silva NF, Menezes-Reis LT, Vieira LG, Hirano LQL, Botelho FV, Ribeiro DL, Zanon RG. Prenatal effects of alprazolam treatment on the immature cerebellum of rats. Int J Dev Neurosci. 2022 Dec;82(8):727-735. doi: 10.1002/jdn.10222. Epub 2022 Aug 5.
PubMed 35916248Elgarf AA, Siebert DCB, Steudle F, Draxler A, Li G, Huang S, Cook JM, Ernst M, Scholze P. Different Benzodiazepines Bind with Distinct Binding Modes to GABAA Receptors. ACS Chem Biol. 2018 Aug 17;13(8):2033-2039. doi: 10.1021/acschembio.8b00144. Epub 2018 Jul 23.
PubMed 29767950Pachankis YI. Adrenaline Intolerance in ASD Curing From Autoimmune Pathogens - Sebaceous Immunobiology in Autoimmune Pathogen Research. Biomedical Review: Journal of Basic and Applied Medical Sciences. 2023;10(1):8-14.
Kottyan LC, Collier AR, Cao KH, Niese KA, Hedgebeth M, Radu CG, Witte ON, Khurana Hershey GK, Rothenberg ME, Zimmermann N. Eosinophil viability is increased by acidic pH in a cAMP- and GPR65-dependent manner. Blood. 2009 Sep 24;114(13):2774-82. doi: 10.1182/blood-2009-05-220681. Epub 2009 Jul 29.
PubMed 19641187Petersen OH, Gerasimenko OV, Gerasimenko JV. Endocytic uptake of SARS-CoV-2: the critical roles of pH, Ca2+, and NAADP. Function (Oxf). 2020 Jun 5;1(1):zqaa003. doi: 10.1093/function/zqaa003. eCollection 2020. No abstract available.
PubMed 38626245
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detoxification From the Lipid Tract by Cocktail Design
- ClinicalTrials.gov ID
- NCT06357104
- Acronym / sponsor ID
- SCI-CT-0001
- Conditions
- COVID-19 Vaccine Adverse Reaction
- Keywords
- sebaceous immunobiology, lipid, depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pachankis, Yang I., M.D.
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 10 Apr 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.
Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study.
Detailed description
It was tested that GABA, in the joint action with topiramate, modulates macrophage activities by modulating cholesterol-metabolism associated molecules. GABA A receptors exhibit highly dynamic trafficking and cell surface mobility and influence on post-endocytic effects. Benzodiazepines (BZDs) exercise the mechanism of action by facilitating the binding of the inhibitory neurotransmitter GABA at various GABA receptors throughout the central nervous system (CNS). Alprazolam, a type of BZD, was tested by Al-Tubuly, Aburawi, Alghzewi, Gorash and Errwami in joint action with water-soluble beta blocker atenolol, in comparison with the non-selective β-adrenoceptor antagonist propranolol on the pharmacological effects on depression. The study hypothesizes that by replacing the water-soluble beta blocker to lipid-soluble one metoprolol, the effect of detoxification from the lipid and sebaceous immunobiological pathways can be achieved by the clathrin-dependent endocytosis process.
Even though partial progress was made in the NCT05839236 trial by statin therapies, the therapeutic effects have not been lasting nor significant. The study develops from the previous protocol for a cocktail therapy by the joint mechanism of actions of alprazolam, metoprolol, and pravastatin sodium for the detoxification process.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GABA Cocktail | Experimental | Device: electroencephalogram biofeedback, Device: electrical brain stimulation, Device: ultra-low frequency transcranial magnetic stimulation, Drug: Sertraline Hydrochloride, Drug: Clonazepam, Drug: Alprazolam, Drug: Metoprolol, Drug: Olanzapine, Drug: Pravastatin Sodium 20 MG, Drug: Sacubitril Valsartan Sodium Hydrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who received full doses of COVID-19 vaccines.
Key exclusion criteria (1 listed)
- Women during pregnancy.
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 |
|---|---|---|
| electroencephalogram biofeedbackAlso: EBEB is conducted for 20 minutes per section with two sections per day in the primary efficacy endpoint. | Device | GABA Cocktail |
| electrical brain stimulationAlso: EBSEBS is conducted for 20 minutes per section per day in the primary efficacy endpoint. | Device | GABA Cocktail |
| ultra-low frequency transcranial magnetic stimulationAlso: ULF-TMSULF-TMS is conducted mainly for the left side of the participant's brain for 20 minutes per section per day in the primary efficacy endpoint. | Device | GABA Cocktail |
| Sertraline HydrochlorideAlso: SSRISertraline is taken in the morning for 150 mg per day. | Drug | GABA Cocktail |
| ClonazepamClonazepam is taken in the morning for 1 mg per day. | Drug | GABA Cocktail |
| AlprazolamAlprazolam is introduced near the end of the primary efficacy endpoint for 0.4 mg per night. | Drug | GABA Cocktail |
| MetoprololAlso: beta blockerMetoprolol is introduced at the secondary efficacy endpoint starting with 47.5 mg per night and increase to 95 mg per night. | Drug | GABA Cocktail |
| OlanzapineOlanzapine is taken throughout the trial with 7.5 mg per night at first, and increases to 10 mg per night after the cocktail therapy. | Drug | GABA Cocktail |
| Pravastatin Sodium 20 MGPravastatin sodium is introduced in the secondary efficacy endpoint with 20 mg per night. | Drug | GABA Cocktail |
| Sacubitril Valsartan Sodium HydrateAlso: ARNISacubitril valsartan sodium is introduced in the secondary efficacy endpoint with 100 mg per day. | Drug | GABA Cocktail |
Primary outcome
Changes in Leukocyte and Components' Quantities
Time frame: 24 days
All white blood cells are evaluated.
Changes in Leukocyte Components' Ratios
Time frame: 24 days
All white blood cells are evaluated.
Quantity Changes in Megakaryocyte-Erythroid Progenitor
Time frame: 24 days
Changes in Hemoglobin Distribution
Time frame: 24 days
Changes in Mean Corpuscular Hemoglobin
Time frame: 24 days
Changes in Hematocrit
Time frame: 24 days
Changes in Plateletcrit
Time frame: 24 days
Red cell Distribution Width Coefficient of Variation
Time frame: 24 days
Changes in Particulate Matter Sizes
Time frame: 24 days
Changes in Total Lipid Quantities
Time frame: 24 days
Changes in Apolipoproteina
Time frame: 24 days
Changes in Lipoprotein (a)
Time frame: 24 days
2 secondary outcomes
Blood Pressure Changes
Time frame: 24 days
Heart Rate Changes
Time frame: 24 days
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 10 Apr 2024.
- Background: PubMed 31207206Kim H, Nobeyama T, Honda S, Yasuda K, Morone N, Murakami T. Membrane fusogenic high-density lipoprotein nanoparticles. Biochim Biophys Acta Biomembr. 2019 Oct 1;1861(10):183008. doi: 10.1016/j.bbamem.2019.06.007. Epub 2019 Jun 15.
- Background: PubMed 34124081Zhao M, Luo Z, He H, Shen B, Liang J, Zhang J, Ye J, Xu Y, Wang Z, Ye D, Wang M, Wan J. Decreased Low-Density Lipoprotein Cholesterol Level Indicates Poor Prognosis of Severe and Critical COVID-19 Patients: A Retrospective, Single-Center Study. Front Med (Lausanne). 2021 May 26;8:585851. doi: 10.3389/fmed.2021.585851. eCollection 2021.
- Background: PubMed 32428379Glebov OO. Understanding SARS-CoV-2 endocytosis for COVID-19 drug repurposing. FEBS J. 2020 Sep;287(17):3664-3671. doi: 10.1111/febs.15369. Epub 2020 Jun 2.
- BackgroundPachankis YI. Plausibility Review on Lipoprotein (A) Infection Path of S2 Autoimmune Pathogen. Global Journal of Medical Research. 2023;23(3)(C):5-11.
- Background: PubMed 24733016Yang Y, Lian YT, Huang SY, Yang Y, Cheng LX, Liu K. GABA and topiramate inhibit the formation of human macrophage-derived foam cells by modulating cholesterol-metabolism-associated molecules. Cell Physiol Biochem. 2014;33(4):1117-29. doi: 10.1159/000358681. Epub 2014 Apr 9.
- Background: PubMed 32364672Lombardi JP, Kinzlmaier DA, Jacob TC. Visualizing GABA A Receptor Trafficking Dynamics with Fluorogenic Protein Labeling. Curr Protoc Neurosci. 2020 Jun;92(1):e97. doi: 10.1002/cpns.97.
- Background: PubMed 23789008Griffin CE 3rd, Kaye AM, Bueno FR, Kaye AD. Benzodiazepine pharmacology and central nervous system-mediated effects. Ochsner J. 2013 Summer;13(2):214-23.
- Background: PubMed 21499463Al-Tubuly R, Aburawi S, Alghzewi E, Gorash Z, Errwami S. The effect of sympathetic antagonists on the antidepressant action of alprazolam. Libyan J Med. 2008 Jun 1;3(2):78-83. doi: 10.4176/080101.
- Background: PubMed 6118165Hunninghake D, Wallace RB, Reiland S, Barrett-Connor E, Wahl P, Hoover J, Heiss G. Alterations of plasma lipid and lipoprotein levels associated with benzodiazepine use--the LRC Program Prevalence Study. Atherosclerosis. 1981 Oct;40(2):159-65. doi: 10.1016/0021-9150(81)90034-4.
- Background: PubMed 34386973McGrath M, Hoyt H, Pence A, Forman SA, Raines DE. Selective actions of benzodiazepines at the transmembrane anaesthetic binding sites of the GABAA receptor: In vitro and in vivo studies. Br J Pharmacol. 2021 Dec;178(24):4842-4858. doi: 10.1111/bph.15662. Epub 2021 Sep 26.
- Background: PubMed 35916248Mascarenhas FNADP, Silva NF, Menezes-Reis LT, Vieira LG, Hirano LQL, Botelho FV, Ribeiro DL, Zanon RG. Prenatal effects of alprazolam treatment on the immature cerebellum of rats. Int J Dev Neurosci. 2022 Dec;82(8):727-735. doi: 10.1002/jdn.10222. Epub 2022 Aug 5.
- Background: PubMed 29767950Elgarf AA, Siebert DCB, Steudle F, Draxler A, Li G, Huang S, Cook JM, Ernst M, Scholze P. Different Benzodiazepines Bind with Distinct Binding Modes to GABAA Receptors. ACS Chem Biol. 2018 Aug 17;13(8):2033-2039. doi: 10.1021/acschembio.8b00144. Epub 2018 Jul 23.
- Benzodiazepines drug profile. European Monitoring Centre for Drugs and Drug Addiction.Link provided by the sponsor.
- Antianxiety Drugs Successfully Treat AutismLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared on Zenodo repository.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing electroencephalogram biofeedback, electrical brain stimulation and ultra-low frequency transcranial magnetic stimulation in people with COVID-19 Vaccine Adverse Reaction, run by Pachankis, Yang I., M.D. 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 1 inclusion and 1 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 10 Apr 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes in Leukocyte and Components' Quantities (time frame: 24 days). The study lists 12 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 NCT06357104, which also lists 20 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 10 Apr 2024.