COVID-19 Vaccination Detoxification in LDL-C

NCT ID: NCT05839236

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-07-31

Brief Summary

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The study hypothesizes that SARS-CoV-2 vaccination poisoning hibernates in human host in Low Density Lipoprotein Cholesterol (LDL-C). The clinical trial is a follow-up from the intervention trial with NCT number NCT05711810. It tests the use of Atorvastatin Calcium Tablets for detoxification and prevention of blood acidification, and the use of the Chinese herb compounded Anti-Viral Granules for the detoxification in the endocrine system.

Detailed Description

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Conditions

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COVID-19 Stress Syndrome COVID-19 Vaccine Adverse Reaction COVID-19-Associated Thromboembolism COVID-19 Post-Intensive Care Syndrome COVID-19-Associated Stroke COVID-19 Respiratory Infection

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LDL-C Detox

The participant is continued from the trial NCT05711810. The follow-up study is separately registered for the etiological evidence from vaccine poisoning.

With the prior study's angiotensin-converting enzyme receptor inhibition therapy reaching desired power level and outcome, the participant's blood pressure. has dropped to normal range in a steady state without signs of sudden death risks.

The separate study defines the treatment medicines in NCT05711810 as rescue medicines for discretions, and experiments with Atorvastatin Calcium Tablets with 20 mg per day, and Chinese herb compounded Anti-Viral Granules 12 g (total) in 3 times per day.

The main ingredients for Anti-Viral Granules are the roots of Isatis indigotica L., Forsythia suspensa, Gypsum, Common Anemarrhena, Reed Rhizome, Rehmannia glutinosa, Patchouli, Tatarinow Sweerflag Rhizome, and Curcuma aromatica. They're mixed with dextrin, Sodium cyclamate, patchouli oil, peppermint oil, and angelica dahurica tincture.

Group Type EXPERIMENTAL

Atorvastatin Calcium Tablets

Intervention Type COMBINATION_PRODUCT

The intervention observes the effects of the medicines on the participant's health without the continued interventions on blood pressure. Rescue medicines will be used once if the blood pressure rise again beyond the healthy range.

Interventions

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Atorvastatin Calcium Tablets

The intervention observes the effects of the medicines on the participant's health without the continued interventions on blood pressure. Rescue medicines will be used once if the blood pressure rise again beyond the healthy range.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Anti-Viral Granules

Eligibility Criteria

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Inclusion Criteria

* People who received COVID-19 vaccinations, or experiencing long-COVID.

Exclusion Criteria

* People with moderate and severe liver dysfunctions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yang I. Pachankis

INDIV

Sponsor Role lead

Responsible Party

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Yang I. Pachankis

Researcher

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Residential Address

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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Smith KR, Thiboutot DM. Thematic review series: skin lipids. Sebaceous gland lipids: friend or foe? J Lipid Res. 2008 Feb;49(2):271-81. doi: 10.1194/jlr.R700015-JLR200. Epub 2007 Nov 1.

Reference Type BACKGROUND
PMID: 17975220 (View on PubMed)

Lovaszi M, Szegedi A, Zouboulis CC, Torocsik D. Sebaceous-immunobiology is orchestrated by sebum lipids. Dermatoendocrinol. 2017 Oct 17;9(1):e1375636. doi: 10.1080/19381980.2017.1375636. eCollection 2017.

Reference Type BACKGROUND
PMID: 29484100 (View on PubMed)

Zouboulis CC, Coenye T, He L, Kabashima K, Kobayashi T, Niemann C, Nomura T, Olah A, Picardo M, Quist SR, Sasano H, Schneider MR, Torocsik D, Wong SY. Sebaceous immunobiology - skin homeostasis, pathophysiology, coordination of innate immunity and inflammatory response and disease associations. Front Immunol. 2022 Nov 10;13:1029818. doi: 10.3389/fimmu.2022.1029818. eCollection 2022.

Reference Type BACKGROUND
PMID: 36439142 (View on PubMed)

Sorgato MC, Ferguson SJ, Kell DB, John P. The protonmotive force in bovine heart submitochondrial particles. Magnitude, sites of generation and comparison with the phosphorylation potential. Biochem J. 1978 Jul 15;174(1):237-56. doi: 10.1042/bj1740237.

Reference Type BACKGROUND
PMID: 212021 (View on PubMed)

EVANS MC. THE PHOTO-OXIDATION OF SUCCINATE BY CHROMATOPHORES OF RHODOSPIRILLUM RUBRUM. Biochem J. 1965 Jun;95(3):661-8. doi: 10.1042/bj0950661.

Reference Type BACKGROUND
PMID: 14342500 (View on PubMed)

Mackey K, Ayers CK, Kondo KK, Saha S, Advani SM, Young S, Spencer H, Rusek M, Anderson J, Veazie S, Smith M, Kansagara D. Racial and Ethnic Disparities in COVID-19-Related Infections, Hospitalizations, and Deaths : A Systematic Review. Ann Intern Med. 2021 Mar;174(3):362-373. doi: 10.7326/M20-6306. Epub 2020 Dec 1.

Reference Type BACKGROUND
PMID: 33253040 (View on PubMed)

Mathur R, Rentsch CT, Morton CE, Hulme WJ, Schultze A, MacKenna B, Eggo RM, Bhaskaran K, Wong AYS, Williamson EJ, Forbes H, Wing K, McDonald HI, Bates C, Bacon S, Walker AJ, Evans D, Inglesby P, Mehrkar A, Curtis HJ, DeVito NJ, Croker R, Drysdale H, Cockburn J, Parry J, Hester F, Harper S, Douglas IJ, Tomlinson L, Evans SJW, Grieve R, Harrison D, Rowan K, Khunti K, Chaturvedi N, Smeeth L, Goldacre B; OpenSAFELY Collaborative. Ethnic differences in SARS-CoV-2 infection and COVID-19-related hospitalisation, intensive care unit admission, and death in 17 million adults in England: an observational cohort study using the OpenSAFELY platform. Lancet. 2021 May 8;397(10286):1711-1724. doi: 10.1016/S0140-6736(21)00634-6. Epub 2021 Apr 30.

Reference Type BACKGROUND
PMID: 33939953 (View on PubMed)

Zhao 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.

Reference Type BACKGROUND
PMID: 34124081 (View on PubMed)

Knox PP, Lukashev EP, Korvatovskii BN, Seifullina NK, Goryachev SN, Allakhverdiev ES, Paschenko VZ. Effect of Dipyridamole on Membrane Energization and Energy Transfer in Chromatophores of Rba. sphaeroides. Biochemistry (Mosc). 2022 Oct;87(10):1138-1148. doi: 10.1134/S0006297922100078.

Reference Type BACKGROUND
PMID: 36273882 (View on PubMed)

DE Flora S, Balansky R, LA Maestra S. Antioxidants and COVID-19. J Prev Med Hyg. 2021 Jun 5;62(1 Suppl 3):E34-E45. doi: 10.15167/2421-4248/jpmh2021.62.1S3.1895. eCollection 2021 Mar. Italian.

Reference Type BACKGROUND
PMID: 34622082 (View on PubMed)

Seneff S, Kyriakopoulos AM, Nigh G, McCullough PA. A Potential Role of the Spike Protein in Neurodegenerative Diseases: A Narrative Review. Cureus. 2023 Feb 11;15(2):e34872. doi: 10.7759/cureus.34872. eCollection 2023 Feb.

Reference Type BACKGROUND
PMID: 36788995 (View on PubMed)

Salih RQ, Salih GA, Abdulla BA, Ahmed AD, Mohammed HR, Kakamad FH, Salih AM. False-positive HIV in a patient with SARS-CoV-2 infection; a case report. Ann Med Surg (Lond). 2021 Nov;71:103027. doi: 10.1016/j.amsu.2021.103027. Epub 2021 Nov 6.

Reference Type BACKGROUND
PMID: 34777794 (View on PubMed)

Yang IP. Theoretical Strategies in SARS-CoV-2 Human Host Treatment. Journal of Clinical and Medical Images. 2023; 6(28).

Reference Type BACKGROUND

Yang IP. Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on "Vaccinated" Immune Attacks. Biomedical Science and Clinical Research. 2023; 2(1): 86-93.

Reference Type BACKGROUND

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

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Study Documents

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Document Type: Individual Participant Data Set

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Other Identifiers

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SARSCoVVAXDetox

Identifier Type: -

Identifier Source: org_study_id

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