Medicine-induced Cardiac Hemodialysis on COVID-19

Renal Dialysis Clinical Trial

Official title:

Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on "Vaccinated" Immune Attacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05711810
• Other study ID #: SARSCoVVaxPoison
• Status: Completed
• Phase: Phase 4
• Start date: January 2, 2023
• Est. completion date: January 12, 2023

Study information

• Verified date: February 2023
• Source: Pachankis, Yang I., M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical trial studies the human pathogen of SARS-CoV-2, with a specificity in the circulating Spike 2 protein in the human system. The clinical trial hypothesizes that SARS-CoV-2 human pathogen arises from immune attacks, underlying the severe physiological symptoms that can be lethal. It further hypothesizes that the vaccines do not deal with the Spike 2 protein that causes the immune attacks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 12, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• No mRNA vaccinated poisoning have been included currently, but scientific evidence suggest the methods of vaccination are irrelevant to the conditions. It is theorized that the more advanced the vaccine production technology, the deeper the poisoning.

Exclusion Criteria:

• healthy individuals with no myocarditis or unvaccinated without infection by SARS-CoV series

• persons with diabetes (Paxlovid and PrEP treatments can be applied according to availability)

Related Conditions & MeSH terms

• Infection Viral
• Infections
• Myocarditis
• Renal Dialysis
• Severe Acute Respiratory Syndrome
• Vaccines
• Virus Diseases

Intervention

Drug:
• Nifedipine 30 MG
Due to initial availability of drugs and the intensities of the patient's symptoms, Nifedipine was used for initial intervention in preventing acute myocarditis from happening.

Diagnostic Test:
• Kangzhu BPCB0A-3A
The diagnostic test has been used to confirm objective parameters to guide the intervention drug dosages and accessing the risks in sudden death and long term adverse effects.

Behavioral:
• Low Mobility
The behavioral intervention aimed at reducing the risks of sudden and strong blood flows in the patient's system.

Drug:
• Enalapril Maleate 10Mg Tab
The intervention aims to reduce the vein flows in Diastolic Blood Pressure, and the risks in blood clot formation and internal vein scratch bleeding.
• Lansoprazole 30Mg Ec Cap
The intervention aims to server the allergy-inducing proteins to induce renal hemodialysis.
• Metoprolol Succinate
Metoprolol Succinate is used to control the cardiac artery flow amounts and stabilize the patient's heart rate.

Dietary Supplement:
• Coenzyme Q10
200 mg per day is used for supplement with the cardiac interventions.
• d-alpha tocopherol acetate
The 268 mg twice per day dietary healthcare is the patient's usual daily use.
• Omega-3
The 900 mg twice per day dietary healthcare is the patient's usual daily use.

Drug:
• Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed Release
Duloxetine hydrochloride is used for the patient's neurodiverse conditions.
• Superoxide Dismutase
Superoxide Dismutase is used to substitute the missing of antiviral drugs.

Locations

Country	Name	City	State
China	Residential Address	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Yang I. Pachankis

Country where clinical trial is conducted

China, 

References & Publications (20)

Bradley BT, Bryan A, Fink SL, Goecker EA, Roychoudhury P, Huang ML, Zhu H, Chaudhary A, Madarampalli B, Lu JYC, Strand K, Whimbey E, Bryson-Cahn C, Schippers A, Mani NS, Pepper G, Jerome KR, Morishima C, Coombs RW, Wener M, Cohen S, Greninger AL. Anti-SARS-CoV-2 Antibody Levels Measured by the AdviseDx SARS-CoV-2 Assay Are Concordant with Previously Available Serologic Assays but Are Not Fully Predictive of Sterilizing Immunity. J Clin Microbiol. 2021 Aug 18;59(9):e0098921. doi: 10.1128/JCM.00989-21. Epub 2021 Aug 18. — View Citation

Cure E, Cumhur Cure M. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers may be harmful in patients with diabetes during COVID-19 pandemic. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):349-350. doi: 10.1016/j.dsx.2020.04.019. Epub 2020 Apr 15. — View Citation

Dilip KG. Poison as Discussed by Susruta, The Father of Surgery. Biomedical Science and Clinical Research. 2022; 1(1): 18-20.

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Fischer W, Giorgi EE, Chakraborty S, Nguyen K, Bhattacharya T, Theiler J, Goloboff PA, Yoon H, Abfalterer W, Foley BT, Tegally H, San JE, de Oliveira T; Network for Genomic Surveillance in South Africa (NGS-SA); Gnanakaran S, Korber B. HIV-1 and SARS-CoV-2: Patterns in the evolution of two pandemic pathogens. Cell Host Microbe. 2021 Jul 14;29(7):1093-1110. doi: 10.1016/j.chom.2021.05.012. Epub 2021 Jun 3. — View Citation

Glebov 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. — View Citation

Goldstein FC, Steenland K, Zhao L, Wharton W, Levey AI, Hajjar I. Proton Pump Inhibitors and Risk of Mild Cognitive Impairment and Dementia. J Am Geriatr Soc. 2017 Sep;65(9):1969-1974. doi: 10.1111/jgs.14956. Epub 2017 Jun 7. — View Citation

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Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol. 2021 Mar;19(3):141-154. doi: 10.1038/s41579-020-00459-7. Epub 2020 Oct 6. Erratum In: Nat Rev Microbiol. 2022 May;20(5):315. — View Citation

Liu X, Mostafavi H, Ng WH, Freitas JR, King NJC, Zaid A, Taylor A, Mahalingam S. The Delta SARS-CoV-2 Variant of Concern Induces Distinct Pathogenic Patterns of Respiratory Disease in K18-hACE2 Transgenic Mice Compared to the Ancestral Strain from Wuhan. mBio. 2022 Jun 28;13(3):e0068322. doi: 10.1128/mbio.00683-22. Epub 2022 Apr 14. — View Citation

Ortiz-Guerrero G, Amador-Munoz D, Calderon-Ospina CA, Lopez-Fuentes D, Nava Mesa MO. Proton Pump Inhibitors and Dementia: Physiopathological Mechanisms and Clinical Consequences. Neural Plast. 2018 Mar 21;2018:5257285. doi: 10.1155/2018/5257285. eCollection 2018. — View Citation

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Poea-Guyon S, Ammar MR, Erard M, Amar M, Moreau AW, Fossier P, Gleize V, Vitale N, Morel N. The V-ATPase membrane domain is a sensor of granular pH that controls the exocytotic machinery. J Cell Biol. 2013 Oct 28;203(2):283-98. doi: 10.1083/jcb.201303104. — View Citation

Ragia G, Manolopoulos VG. Inhibition of SARS-CoV-2 entry through the ACE2/TMPRSS2 pathway: a promising approach for uncovering early COVID-19 drug therapies. Eur J Clin Pharmacol. 2020 Dec;76(12):1623-1630. doi: 10.1007/s00228-020-02963-4. Epub 2020 Jul 21. — View Citation

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Yang IP. Public health equity in information asymmetry - phenomenological studies upon SARS-CoV-2 super- virus mutation. International Physical Medicine & Rehabilitation Journal. 2023; 8(1): 14-18.

Yonker LM, Swank Z, Bartsch YC, Burns MD, Kane A, Boribong BP, Davis JP, Loiselle M, Novak T, Senussi Y, Cheng CA, Burgess E, Edlow AG, Chou J, Dionne A, Balaguru D, Lahoud-Rahme M, Arditi M, Julg B, Randolph AG, Alter G, Fasano A, Walt DR. Circulating Spike Protein Detected in Post-COVID-19 mRNA Vaccine Myocarditis. Circulation. 2023 Jan 4. doi: 10.1161/CIRCULATIONAHA.122.061025. Online ahead of print. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	The heart rate is monitored daily, and the primary goal is to stabilize the patient's heart rate.	1 day
Primary	Electrocardiogram	Electrocardiogram reflects the blood pressure management on the patient's health outcome and potential risks.	20 days
Primary	Platelet Distribution	Platelet distribution is measured to determine the viral induced blood-borne pathogen in the physiological responses of the patient.	10 days
Primary	Mean Platelet Volume	MPV is measured to determine the risks in blood clot and internal vein scratches in the patient.	10 days
Primary	Eosinophil Absolute Number	Eosinophil Absolute Number is measured to determine the intensities of infection in the patient.	10 days
Primary	Basophil Absolute Number	Basophil Absolute Number is measured on the counteraction of the patient's immune system integrities against the rapid acidification of the viral infection.	10 days
Secondary	Cardiac Enzymes	Cardiac enzymes are measured to locate and eliminate the symptoms' causes, identify potential health risks, and to determine if subsidiary treatments are needed.	10 days

External Links

•   Angiotensin Converting Enzyme Inhibitors (ACEI)
•   B6.Cg-Tg(K18-ACE2)2Prlmn/J
•   Low basophil count in the blood
•   Normal basophil count in the blood
•   Proton Pump Inhibitors
•   SARS CoV 2 Spike Antibody, IgG