COVID-19 Vaccination Detoxification in LDL-C

May 4, 2023 updated by: Yang I. Pachankis

COVID-19 Vaccination Detoxication in Low Density Lipoprotein Cholesterol

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 402762
        • Residential Address

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • People who received COVID-19 vaccinations, or experiencing long-COVID.

Exclusion Criteria:

  • People with moderate and severe liver dysfunctions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LDL-C Detox

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.
Combination product: Atorvastatin Calcium Tablets
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.
Other Names:
  • Anti-Viral Granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol Change
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
30 days
Apolipoproteina B Change
Time Frame: 30 days
30 days
Lipopoliproteina (a) Change
Time Frame: 30 days
30 days
Eosinophil Absolute Number Change
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
30 days
Plateletcrit Change
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Change
Time Frame: 4 hours
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
Systolic Blood Pressure Change
Time Frame: 4 hours
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
Time Frame: 4 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yang I. Pachankis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARSCoVVAXDetox

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data collected will be deidentified and shared on Zenodo with the same entry currently assigned the doi: 10.5281/zenodo.7856000.

IPD Sharing Time Frame

60 days.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 10.5281/zenodo.7883407
    Information comments: The identifier is reserved and the repository team is helping solving the technical issues in updating the data with the renewed identifier.

Drug and device information, study documents

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

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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