Medicine-induced Cardiac Hemodialysis on COVID-19

NCT05711810 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: SARSCoVVaxPoison
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Heart Rate

  The heart rate is monitored daily, and the primary goal is to stabilize the patient's heart rate.

  1 day

• Electrocardiogram

  Electrocardiogram reflects the blood pressure management on the patient's health outcome and potential risks.

  20 days

• Platelet Distribution

  Platelet distribution is measured to determine the viral induced blood-borne pathogen in the physiological responses of the patient.

  10 days

• Mean Platelet Volume

  MPV is measured to determine the risks in blood clot and internal vein scratches in the patient.

  10 days

• Eosinophil Absolute Number

  Eosinophil Absolute Number is measured to determine the intensities of infection in the patient.

  10 days

• 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 Outcomes (1)

• Cardiac Enzymes

  10 days

Study Arms (1)

Experiment Participant

EXPERIMENTAL

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.

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

Interventions

Nifedipine 30 MG DRUG

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.

Also known as: Nifedipine Control-release Tablets

Experiment Participant

Kangzhu BPCB0A-3A DIAGNOSTIC_TEST

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.

Also known as: Heart Monitor

Experiment Participant

Low Mobility BEHAVIORAL

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

Experiment Participant

Enalapril Maleate 10Mg Tab DRUG

The intervention aims to reduce the vein flows in Diastolic Blood Pressure, and the risks in blood clot formation and internal vein scratch bleeding.

Experiment Participant

Lansoprazole 30Mg Ec Cap DRUG

The intervention aims to server the allergy-inducing proteins to induce renal hemodialysis.

Experiment Participant

Metoprolol Succinate DRUG

Metoprolol Succinate is used to control the cardiac artery flow amounts and stabilize the patient's heart rate.

Experiment Participant

Coenzyme Q10 DIETARY_SUPPLEMENT

200 mg per day is used for supplement with the cardiac interventions.

Experiment Participant

d-alpha tocopherol acetate DIETARY_SUPPLEMENT

The 268 mg twice per day dietary healthcare is the patient's usual daily use.

Experiment Participant

Omega-3 DIETARY_SUPPLEMENT

The 900 mg twice per day dietary healthcare is the patient's usual daily use.

Experiment Participant

Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed Release DRUG

Duloxetine hydrochloride is used for the patient's neurodiverse conditions.

Also known as: Neurodiverse

Experiment Participant

Superoxide Dismutase DRUG

Superoxide Dismutase is used to substitute the missing of antiviral drugs.

Experiment Participant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yang I. Pachankis: lead

Study Sites (1)

Residential Address

Chongqing, Chongqing Municipality, 402762, China

Location

Related Publications (20)

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  BACKGROUND

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  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Virus Diseases

Interventions

Nifedipine; low mobility group protein 160, rat; Enalapril; Lansoprazole; Metoprolol; coenzyme Q10; alpha-Tocopherol; Docosahexaenoic Acids; Duloxetine Hydrochloride; Capsules; Superoxide Dismutase

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Tocopherols; Vitamin E; Benzopyrans; Pyrans; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Thiophenes; Dosage Forms; Pharmaceutical Preparations; Oxidoreductases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 3, 2023
• Study Start: January 2, 2023
• Primary Completion: January 10, 2023
• Study Completion: January 12, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The first 20 days of data have been uploaded on Zenodo, and significant results and monitoring data will be updated accordingly.
• Access Criteria: The data is openly available on Zenodo. The hospital facility and personnel involved for prescription drugs and tests are deidentified.

Locations

CN (1)