- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05711810
Medicine-induced Cardiac Hemodialysis on COVID-19
Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on "Vaccinated" Immune Attacks
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Nifedipine 30 MG
- Diagnostic test: Kangzhu BPCB0A-3A
- Behavioral: Low Mobility
- Drug: Enalapril Maleate 10Mg Tab
- Drug: Lansoprazole 30Mg Ec Cap
- Drug: Metoprolol Succinate
- Dietary supplement: Coenzyme Q10
- Dietary supplement: d-alpha tocopherol acetate
- Dietary supplement: Omega-3
- Drug: Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed Release
- Drug: Superoxide Dismutase
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China, 402762
- Residential Address
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experiment Participant
COVID-19 recombined vaccinated, 3 dose, no intervention. Nifedipine, oral, 30 mg per day for 2 days, active comparative. Angiotensin-converting enzyme inhibitor, oral, gradually increase to 20 mg per day at night. Beta blocker, oral, 23.75 - 95 mg per day in the morning. Proton-pump inhibitor, oral, 30 mg per day. Duloxetine hydrochloride, oral, placebo, 20 mg per day before sleep. Acetaminophen (sham comparator), oral, 250 mg four times per day for 8 days. Cefuroxime (sham comparator), oral, 100 mg twice per day for 6 days. Papaverine, oral, low-dosage in coughing pills for 4 days. Superoxide Dismutase (active comparator), oral, to be introduced. Bafilomycin A1 (active comparator), oral, 100 ug per kilogram per day, unlikely to be introduced for lack of funding. |
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.
Other Names:
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.
Other Names:
The behavioral intervention aimed at reducing the risks of sudden and strong blood flows in the patient's system.
The intervention aims to reduce the vein flows in Diastolic Blood Pressure, and the risks in blood clot formation and internal vein scratch bleeding.
The intervention aims to server the allergy-inducing proteins to induce renal hemodialysis.
Metoprolol Succinate is used to control the cardiac artery flow amounts and stabilize the patient's heart rate.
200 mg per day is used for supplement with the cardiac interventions.
The 268 mg twice per day dietary healthcare is the patient's usual daily use.
The 900 mg twice per day dietary healthcare is the patient's usual daily use.
Duloxetine hydrochloride is used for the patient's neurodiverse conditions.
Other Names:
Superoxide Dismutase is used to substitute the missing of antiviral drugs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate
Time Frame: 1 day
|
The heart rate is monitored daily, and the primary goal is to stabilize the patient's heart rate.
|
1 day
|
Electrocardiogram
Time Frame: 20 days
|
Electrocardiogram reflects the blood pressure management on the patient's health outcome and potential risks.
|
20 days
|
Platelet Distribution
Time Frame: 10 days
|
Platelet distribution is measured to determine the viral induced blood-borne pathogen in the physiological responses of the patient.
|
10 days
|
Mean Platelet Volume
Time Frame: 10 days
|
MPV is measured to determine the risks in blood clot and internal vein scratches in the patient.
|
10 days
|
Eosinophil Absolute Number
Time Frame: 10 days
|
Eosinophil Absolute Number is measured to determine the intensities of infection in the patient.
|
10 days
|
Basophil Absolute Number
Time Frame: 10 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Enzymes
Time Frame: 10 days
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Wu Zhang X, Leng Yap Y. Structural similarity between HIV-1 gp41 and SARS-CoV S2 proteins suggests an analogous membrane fusion mechanism. Theochem. 2004 May;677(1):73-76. doi: 10.1016/j.theochem.2004.02.018. Epub 2004 Apr 2.
- 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.
- Xavier LL, Neves PFR, Paz LV, Neves LT, Bagatini PB, Timmers LFSM, Rasia-Filho AA, Mestriner RG, Wieck A. Does Angiotensin II Peak in Response to SARS-CoV-2? Front Immunol. 2021 Jan 14;11:577875. doi: 10.3389/fimmu.2020.577875. eCollection 2020.
- 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.
- Tabares L, Betz B. Multiple functions of the vesicular proton pump in nerve terminals. Neuron. 2010 Dec 22;68(6):1020-2. doi: 10.1016/j.neuron.2010.12.012.
- 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.
- 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.
- Wang D, Hiesinger PR. The vesicular ATPase: a missing link between acidification and exocytosis. J Cell Biol. 2013 Oct 28;203(2):171-3. doi: 10.1083/jcb.201309130.
- 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.
- 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.
- 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.
- Duwal S, Schutte C, von Kleist M. Pharmacokinetics and pharmacodynamics of the reverse transcriptase inhibitor tenofovir and prophylactic efficacy against HIV-1 infection. PLoS One. 2012;7(7):e40382. doi: 10.1371/journal.pone.0040382. Epub 2012 Jul 11. Erratum In: PLoS One. 2012;7(11). doi:10.1371/annotation/fb73d0f4-1cd8-481d-bddd-20439896102a.
- 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.
- Graham RL, Baric RS. Recombination, reservoirs, and the modular spike: mechanisms of coronavirus cross-species transmission. J Virol. 2010 Apr;84(7):3134-46. doi: 10.1128/JVI.01394-09. Epub 2009 Nov 11.
- Pham AQ, Xu LH, Moe OW. Drug-Induced Metabolic Acidosis. F1000Res. 2015 Dec 16;4:F1000 Faculty Rev-1460. doi: 10.12688/f1000research.7006.1. eCollection 2015.
- 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.
- Dilip KG. Poison as Discussed by Susruta, The Father of Surgery. Biomedical Science and Clinical Research. 2022; 1(1): 18-20.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Cardiomyopathies
- Severe Acute Respiratory Syndrome
- Infections
- Virus Diseases
- Myocarditis
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Gastrointestinal Agents
- Protease Inhibitors
- Protective Agents
- Micronutrients
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Vitamins
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Antioxidants
- Free Radical Scavengers
- Angiotensin-Converting Enzyme Inhibitors
- Tocolytic Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Duloxetine Hydrochloride
- Lansoprazole
- Vitamin E
- Tocopherols
- alpha-Tocopherol
- Enalaprilat
- Enalapril
- Metoprolol
- Nifedipine
- Coenzyme Q10
- Superoxide Dismutase
- Ubiquinone
Other Study ID Numbers
- SARSCoVVaxPoison
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Study Data/Documents
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Clinical Study Report
Information identifier: 10.5281/zenodo.7534361Information comments: The local hospital and medicare information are deidentified for their protection.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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