Back to resultsCOVID-19 Vaccination Detoxification in LDL-C
Primary Purpose
COVID-19 Stress Syndrome, COVID-19 Vaccine Adverse Reaction, COVID-19-Associated Thromboembolism
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Atorvastatin Calcium Tablets
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Stress Syndrome focused on measuring COVID-19, SARS-CoV-2, Low Density Lipoprotein Cholesterol, sebum, immune reflex, immunology, immune deficiency, immune regulation, detoxification
Eligibility Criteria
Inclusion Criteria: People who received COVID-19 vaccinations, or experiencing long-COVID. Exclusion Criteria: People with moderate and severe liver dysfunctions.
Sites / Locations
- Residential Address
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LDL-C Detox
Arm Description
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.
Outcomes
Primary Outcome Measures
Total Cholesterol Change
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.
Triglycerides Change
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.
HDL-C Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
LDL-C Change
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.
Apolipoprotein A-I Change
Apolipoproteina B Change
Lipopoliproteina (a) Change
Eosinophil Absolute Number Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Eosinophil Percentage Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Basophil Absolute Number Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Basophil Percentage Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Corpuscular Volume Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Corpuscular Hemoglobin Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Corpuscular Hemoglobin Concentration Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Red cell Distribution Width Coefficient of Variation Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Red cell Distribution Width Standard Deviation Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Plateletcrit Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Platelet Distribution Width Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Mean Platelet Volume Change
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Secondary Outcome Measures
Heart Rate Change
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.
Systolic Blood Pressure Change
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.
Diastolic Blood Pressure Change
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05839236
Brief Title
COVID-19 Vaccination Detoxification in LDL-C
Official Title
COVID-19 Vaccination Detoxication in Low Density Lipoprotein Cholesterol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
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
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Stress Syndrome, COVID-19 Vaccine Adverse Reaction, COVID-19-Associated Thromboembolism, COVID-19 Post-Intensive Care Syndrome, COVID-19-Associated Stroke, COVID-19 Respiratory Infection
Keywords
COVID-19, SARS-CoV-2, Low Density Lipoprotein Cholesterol, sebum, immune reflex, immunology, immune deficiency, immune regulation, detoxification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LDL-C Detox
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Atorvastatin Calcium Tablets
Other Intervention Name(s)
Anti-Viral Granules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Cholesterol Change
Description
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.
Time Frame
30 days
Title
Triglycerides Change
Description
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.
Time Frame
30 days
Title
HDL-C Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
LDL-C Change
Description
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.
Time Frame
30 days
Title
Apolipoprotein A-I Change
Time Frame
30 days
Title
Apolipoproteina B Change
Time Frame
30 days
Title
Lipopoliproteina (a) Change
Time Frame
30 days
Title
Eosinophil Absolute Number Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Eosinophil Percentage Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Basophil Absolute Number Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Basophil Percentage Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Mean Corpuscular Volume Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Mean Corpuscular Hemoglobin Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Mean Corpuscular Hemoglobin Concentration Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Red cell Distribution Width Coefficient of Variation Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Red cell Distribution Width Standard Deviation Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Plateletcrit Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Platelet Distribution Width Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Title
Mean Platelet Volume Change
Description
The baseline characteristics is set at the beginning of the trial, with its rate of change metrified from initial intoxication.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Heart Rate Change
Description
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.
Time Frame
4 hours
Title
Systolic Blood Pressure Change
Description
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.
Time Frame
4 hours
Title
Diastolic Blood Pressure Change
Description
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.
Time Frame
4 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
People who received COVID-19 vaccinations, or experiencing long-COVID.
Exclusion Criteria:
People with moderate and severe liver dysfunctions.
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 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.
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Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://doi.org/10.5281/zenodo.7856000
Available IPD/Information Identifier
10.5281/zenodo.7883407
Available IPD/Information Comments
The identifier is reserved and the repository team is helping solving the technical issues in updating the data with the renewed identifier.
Learn more about this trial
COVID-19 Vaccination Detoxification in LDL-C
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