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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Calcium Tablets | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Change | The blood pressure change will be compared with the baseline characteristics for observation on the risks of rebound to the previous intervention. Type I error testing defines Systolic & Diastolic Blood Pressure and heart rate as incremented. Heart rate variance indicates to immune responses. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Residential Address | Chongqing | Chongqing Municipality | 402762 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17975220 | Background | 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. | |
| 29484100 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 10.5281/zenodo.7883407 | Individual Participant Data Set | View IPD |
The data collected will be deidentified and shared on Zenodo with the same entry currently assigned the doi: 10.5281/zenodo.7856000.
60 days.
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.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 30, 2023 | |
| Reset | Jun 29, 2023 | |
| Release | Jun 30, 2023 | |
| Reset | Jul 28, 2023 | |
| Release | Oct 15, 2023 | |
| Reset | Nov 14, 2023 | |
| Release | Nov 24, 2023 | |
| Reset | Dec 21, 2023 | |
| Release | Dec 26, 2023 | |
| Reset | Jul 3, 2024 | |
| Release | Jul 13, 2024 | |
| Reset | Oct 31, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2023 | May 4, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2023 | May 4, 2023 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 30, 2023 | Jun 29, 2023 | |||
| Jun 30, 2023 |
| ID | Term |
|---|---|
| C000711430 | COVID-19 stress syndrome |
| C000711429 | COVID-19 post-intensive care syndrome |
| D000086382 | COVID-19 |
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
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 |
| Systolic Blood Pressure Change |
The blood pressure change will be compared with the baseline characteristics for observation on the risks of rebound to the previous intervention. Type I error testing defines Systolic & Diastolic Blood Pressure and heart rate as incremented. SBP variance indicates to infection activities. |
| 4 hours |
| Diastolic Blood Pressure Change | The blood pressure change will be compared with the baseline characteristics for observation on the risks of rebound to the previous intervention. Type I error testing defines Systolic & Diastolic Blood Pressure and heart rate as incremented. DBP variance indicates to immune attack activities. | 4 hours |
| 36439142 | Background | 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. |
| 212021 | Background | 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. |
| 14342500 | Background | EVANS MC. THE PHOTO-OXIDATION OF SUCCINATE BY CHROMATOPHORES OF RHODOSPIRILLUM RUBRUM. Biochem J. 1965 Jun;95(3):661-8. doi: 10.1042/bj0950661. |
| 33253040 | Background | 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. |
| 33939953 | Background | 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. |
| 34124081 | Background | 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. |
| 36273882 | Background | 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. |
| 34622082 | Background | 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. |
| 36788995 | Background | 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. |
| 34777794 | Background | 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. |
| Background | 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. |
The identifier is reserved and the repository team is helping solving the technical issues in updating the data with the renewed identifier. |
| Jul 28, 2023 |
| Oct 15, 2023 | Nov 14, 2023 |
| Nov 24, 2023 | Dec 21, 2023 |
| Dec 26, 2023 | Jul 3, 2024 |
| Jul 13, 2024 | Oct 31, 2024 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007154 | Immune System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |