COVID-19 Vaccination Detoxification in LDL-C

Study Overview
=================
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.

Official Title
-----------------
COVID-19 Vaccination Detoxication in Low Density Lipoprotein Cholesterol

Conditions
-----------------
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

Intervention / Treatment
-----------------
* Combination Product: Atorvastatin Calcium Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People who received COVID-19 vaccinations, or experiencing long-COVID. Exclusion Criteria: People with moderate and severe liver dysfunctions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LDL-C Detox<br>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<br>* 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.<br>* Other names: Anti-Viral Granules;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-CoV-2, Low Density Lipoprotein Cholesterol, sebum, immune reflex, immunology, immune deficiency, immune regulation, detoxification