Back to resultsMedicine-induced Cardiac Hemodialysis on COVID-19
Primary Purpose
Severe Acute Respiratory Syndrome-related Coronavirus, Renal Dialysis, Vaccines
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nifedipine 30 MG
Kangzhu BPCB0A-3A
Low Mobility
Enalapril Maleate 10Mg Tab
Lansoprazole 30Mg Ec Cap
Metoprolol Succinate
Coenzyme Q10
d-alpha tocopherol acetate
Omega-3
Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed Release
Superoxide Dismutase
Sponsored by
About this trial
This is an interventional basic science trial for Severe Acute Respiratory Syndrome-related Coronavirus focused on measuring immune infection, neural infection, spike 2 protein, poison, SARS-CoV-2, precarditis
Eligibility Criteria
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)
Sites / Locations
- Residential Address
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experiment Participant
Arm Description
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.
Outcomes
Primary Outcome Measures
Heart Rate
The heart rate is monitored daily, and the primary goal is to stabilize the patient's heart rate.
Electrocardiogram
Electrocardiogram reflects the blood pressure management on the patient's health outcome and potential risks.
Platelet Distribution
Platelet distribution is measured to determine the viral induced blood-borne pathogen in the physiological responses of the patient.
Mean Platelet Volume
MPV is measured to determine the risks in blood clot and internal vein scratches in the patient.
Eosinophil Absolute Number
Eosinophil Absolute Number is measured to determine the intensities of infection in the patient.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05711810
Brief Title
Medicine-induced Cardiac Hemodialysis on COVID-19
Official Title
Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on "Vaccinated" Immune Attacks
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yang I. Pachankis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome-related Coronavirus, Renal Dialysis, Vaccines, Myocarditis Allergic, Infection Viral
Keywords
immune infection, neural infection, spike 2 protein, poison, SARS-CoV-2, precarditis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The crossover model intervenes on the precarditis and myocarditis happenings on the patient, and evaluates the cause of the symptoms. Basic medicines are tested against the pathogens with the immune responses of the patient.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experiment Participant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nifedipine 30 MG
Other Intervention Name(s)
Nifedipine Control-release Tablets
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Kangzhu BPCB0A-3A
Other Intervention Name(s)
Heart Monitor
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Mobility
Intervention Description
The behavioral intervention aimed at reducing the risks of sudden and strong blood flows in the patient's system.
Intervention Type
Drug
Intervention Name(s)
Enalapril Maleate 10Mg Tab
Intervention Description
The intervention aims to reduce the vein flows in Diastolic Blood Pressure, and the risks in blood clot formation and internal vein scratch bleeding.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 30Mg Ec Cap
Intervention Description
The intervention aims to server the allergy-inducing proteins to induce renal hemodialysis.
Intervention Type
Drug
Intervention Name(s)
Metoprolol Succinate
Intervention Description
Metoprolol Succinate is used to control the cardiac artery flow amounts and stabilize the patient's heart rate.
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
200 mg per day is used for supplement with the cardiac interventions.
Intervention Type
Dietary Supplement
Intervention Name(s)
d-alpha tocopherol acetate
Intervention Description
The 268 mg twice per day dietary healthcare is the patient's usual daily use.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
The 900 mg twice per day dietary healthcare is the patient's usual daily use.
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed Release
Other Intervention Name(s)
Neurodiverse
Intervention Description
Duloxetine hydrochloride is used for the patient's neurodiverse conditions.
Intervention Type
Drug
Intervention Name(s)
Superoxide Dismutase
Intervention Description
Superoxide Dismutase is used to substitute the missing of antiviral drugs.
Primary Outcome Measure Information:
Title
Heart Rate
Description
The heart rate is monitored daily, and the primary goal is to stabilize the patient's heart rate.
Time Frame
1 day
Title
Electrocardiogram
Description
Electrocardiogram reflects the blood pressure management on the patient's health outcome and potential risks.
Time Frame
20 days
Title
Platelet Distribution
Description
Platelet distribution is measured to determine the viral induced blood-borne pathogen in the physiological responses of the patient.
Time Frame
10 days
Title
Mean Platelet Volume
Description
MPV is measured to determine the risks in blood clot and internal vein scratches in the patient.
Time Frame
10 days
Title
Eosinophil Absolute Number
Description
Eosinophil Absolute Number is measured to determine the intensities of infection in the patient.
Time Frame
10 days
Title
Basophil Absolute Number
Description
Basophil Absolute Number is measured on the counteraction of the patient's immune system integrities against the rapid acidification of the viral infection.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Cardiac Enzymes
Description
Cardiac enzymes are measured to locate and eliminate the symptoms' causes, identify potential health risks, and to determine if subsidiary treatments are needed.
Time Frame
10 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Residential Address
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
402762
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The emergent intervention started with the PI's research into the virology and post-vaccination adverse effects. The plan was improvised and adjusted accordingly. Statistical analysis was mainly physiological with relation to the virological inductions from the patient's symptomatic responses.
IPD Sharing Time Frame
The first 20 days of data have been uploaded on Zenodo, and significant results and monitoring data will be updated accordingly.
IPD Sharing Access Criteria
The data is openly available on Zenodo. The hospital facility and personnel involved for prescription drugs and tests are deidentified.
IPD Sharing URL
https://doi.org/10.5281/zenodo.7588613
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Links:
URL
http://www.jax.org/strain/034860
Description
B6.Cg-Tg(K18-ACE2)2Prlmn/J
URL
http://patient.info/digestive-health/indigestion-medication/proton-pump-inhibitors
Description
Proton Pump Inhibitors
URL
http://testguide.labmed.uw.edu/view/NCVIGQ?tabs=no
Description
SARS CoV 2 Spike Antibody, IgG
URL
http://www.ncbi.nlm.nih.gov/books/NBK431051/
Description
Angiotensin Converting Enzyme Inhibitors (ACEI)
URL
http://www.mrlabtest.com/low-basophils-blood.htm
Description
Low basophil count in the blood
URL
http://www.mrlabtest.com/normal-basophils-blood.htm
Description
Normal basophil count in the blood
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://doi.org/10.5281/zenodo.7534361
Available IPD/Information Identifier
10.5281/zenodo.7534361
Available IPD/Information Comments
The local hospital and medicare information are deidentified for their protection.
Learn more about this trial
Medicine-induced Cardiac Hemodialysis on COVID-19
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