NCT05839236

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 1, 2023

Last Update Submit

May 4, 2023

Conditions

Keywords

COVID-19SARS-CoV-2Low Density Lipoprotein Cholesterolsebumimmune refleximmunologyimmune deficiencyimmune regulationdetoxification

Outcome Measures

Primary Outcomes (19)

  • Total Cholesterol Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that total cholesterol levels indicate to the initial acidification for SARS-CoV-2 viral entry through vaccines with the degeneration of lipids.

    30 days

  • Triglycerides Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that triglycerides levels indicate to the initial acidification for SARS-CoV-2 viral entry through vaccines.

    30 days

  • HDL-C Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • LDL-C Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication. It is hypothesized that SARS-CoV-2 hibernating viruses and viral proteins are hidden in the LDL-C.

    30 days

  • Apolipoprotein A-I Change

    30 days

  • Apolipoproteina B Change

    30 days

  • Lipopoliproteina (a) Change

    30 days

  • Eosinophil Absolute Number Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Eosinophil Percentage Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Basophil Absolute Number Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Basophil Percentage Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Mean Corpuscular Volume Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Mean Corpuscular Hemoglobin Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Mean Corpuscular Hemoglobin Concentration Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Red cell Distribution Width Coefficient of Variation Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Red cell Distribution Width Standard Deviation Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Plateletcrit Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Platelet Distribution Width Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

  • Mean Platelet Volume Change

    The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.

    30 days

Secondary Outcomes (3)

  • Heart Rate Change

    4 hours

  • Systolic Blood Pressure Change

    4 hours

  • Diastolic Blood Pressure Change

    4 hours

Study Arms (1)

LDL-C Detox

EXPERIMENTAL

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.

Combination Product: Atorvastatin Calcium Tablets

Interventions

Atorvastatin Calcium TabletsCOMBINATION_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.

Also known as: Anti-Viral Granules
LDL-C Detox

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • People with moderate and severe liver dysfunctions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Residential Address

Chongqing, Chongqing Municipality, 402762, China

Location

Related Publications (14)

  • 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.

    PMID: 17975220BACKGROUND
  • 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.

    PMID: 29484100BACKGROUND
  • 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.

    PMID: 36439142BACKGROUND
  • 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.

    PMID: 212021BACKGROUND
  • EVANS MC. THE PHOTO-OXIDATION OF SUCCINATE BY CHROMATOPHORES OF RHODOSPIRILLUM RUBRUM. Biochem J. 1965 Jun;95(3):661-8. doi: 10.1042/bj0950661.

    PMID: 14342500BACKGROUND
  • 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.

    PMID: 33253040BACKGROUND
  • 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.

    PMID: 33939953BACKGROUND
  • 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.

    PMID: 34124081BACKGROUND
  • 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.

    PMID: 36273882BACKGROUND
  • 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.

    PMID: 34622082BACKGROUND
  • 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.

    PMID: 36788995BACKGROUND
  • 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.

    PMID: 34777794BACKGROUND
  • Yang IP. Theoretical Strategies in SARS-CoV-2 Human Host Treatment. Journal of Clinical and Medical Images. 2023; 6(28).

    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.

    BACKGROUND

MeSH Terms

Conditions

COVID-19 stress syndromeCOVID-19 post-intensive care syndromeCOVID-19Immunologic Deficiency Syndromes

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 3, 2023

Study Start

May 1, 2023

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

The data collected will be deidentified and shared on Zenodo with the same entry currently assigned the doi: 10.5281/zenodo.7856000.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
60 days.
Access Criteria
Study protocol with SAP and ICF will be shared at the early phase of the trial. Clinical Study Report will be shared either as a link to publication or directly on the system.

Available IPD Datasets

Individual Participant Data Set (10.5281/zenodo.7883407)Access

Locations