Medical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID)

Study Overview
=================
Brief Summary
-----------------
The human immune system is designed to protect individuals from external sources of infection and internal cell mutation. It works effectively and efficiently until inflammation disturbs its functioning. Once compromised by inflammation, the immune system loses its capacity to recognize antigens and dependably defend the body against disease and illness. When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body's over immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the body without sufficient strength or time to fight back. When the medical herbs join the body, it can slow down the immune reaction. Medical herbs benefit the physical body; they protect the cells and organism structure and mediate the immune response, allowing the T cells to kill the virus (mutated or not) internally. Such success has been achieved by the All Natural Medicine Clinic during pre-clinical trials. This clinical study's goal is to demonstrate that the immune system can be rebuilt and retrained, using natural medicine (i.e., medical herbs), to kill the virus without causing the immune storm, and to explore the mechanism by which these medical herbs, which have been used for thousands of years for healing, achieve results.

Detailed Description
-----------------
According to CDC data, as of January 30, 2021, 25,780,144 individuals residing in the United States had been infected by COVID-19 and 435,151 had died as a result of the disease. No drug has yet been identified that explicitly kills the COVID-19 virus. While various vaccines have been developed to prevent infection, the virus continues to mutate, and scientific research remains behind the virus trajectory. The human immune system, when functioning properly, can prevent the body from succumbing to infections from external sources and from internal cell mutations, including the COVID-19 virus and cancer cells. That is, the defense system comes from nature. This clinical study proves that the immune system can respond to those antigens and kill them if the immune system is given a chance. However, the human immune system can become compromised through inflammation and subsequently unable to successfully prevent infection and cancer. When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body's over-immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the body without sufficient strength or time to fight back. Medical herbs can mediate the immunity disorder caused by infections, and mutated cells, including COVID-19 and its mutations. Our pre-clinical study found that the medical herbs inhibit the inflammation expression, reduce the chance of cytokine-storm, prevent deterioration, and reduce the mortality rate. In addition, the T cells can perform their job when the inflammation is under control. The virus and cancer cells belong to antigens that should be killed by natural killer (NK) cells and T cells. This clinical study aims not to provide drugs to kill the antigens, but rather to create the necessary conditions inside the human body to allow the immune system a chance to overcome the antigens. The clinic has used this treatment concept to successfully treat infected patients and cancer patients.

Official Title
-----------------
The Trial Uses Medicinal Herbs to Direct T Cells to Engulf the COVID-19 Virus and Protect the Organs Well

Conditions
-----------------
Covid19 Virus Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Inflammation (I)
* Dietary Supplement: Inflammation (II)
* Dietary Supplement: Inflammation (III)
* Drug: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A subject will be eligible for inclusion in this study if any of the following criteria apply: Individuals diagnosed with COVID-19 virus infection in the past 1-20 days must submit the proved metrics of COVID-19 virus marks positive during the registration; The age of participants is between 10-70 years old; The participants are received or not received conventional medication treatment, and continuing the treatment patients, could be enrolled in this clinical study; This clinical study is not restricted to gender, age, sex, race, and nationality; The participants must have reports of CBC, C3, C4, IgM, IgG, CD4/CD8, and lungs' images ready before the clinical study; The Participants must repeat the evaluation experiment during and at the end of the clinical study. Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: Individuals with a prior COVID-19 virus infection that no longer shows up from COVID-19 testing; Children who are younger than 10-year-old, cannot control themselves to take the medical herbs on time; Elders whose age beyond 70-year-old, with severe underline illness; COVID-19 virus-infected patients who do not feel willing to take medical herbs; Patients diagnosed with COVID-19 virus infection cannot consistently finish the treatment courses for a specific reason; Patients diagnosed with COVID-19 virus infection but do not willing to share their information with the public; Current or past participation within a specified timeframe in another clinical trial, as warranted by this intervention's administration; Severe patients, when there have insufficient normal cells, can be adjusted, with pre-list diseases life-threatening.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants are randomly divided into two groups: the treatment group and the control group. Both groups receive the same medications, but the treatment group also receives medical herbs to compare both groups' differences on their symptoms and blood data, virus marks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inflammation (I)<br>Upper respiratory inflammation. Fever. Lower respiration inflammation. | Dietary Supplement: Inflammation (I)<br>* upper respiratory inflammation (PurInf (I)): Lonicerae Flos 2.4g, Forsythiae Fructus 2.4g, Schizonepetae Herba 2g, Saposhnikoviae Radix 2g, Cicadae Periostracum 1g, Sophorae flavescentis Radix 2.4g, Atractylodis Rhizoma 2g, Angelicae dahuricae Radix 2g, Menthae haplocalycis Herba 2g, Arctii Fructus 2g, Glycyrrhizae Radix 1g high fever (PurInf (II)): Bupleuri Radix 3g, Scutellariae Radix 2.4g, Gypsum fibrosum 4g, Anemarrhenae Rhizoma 3g lower Respiratory system inflammation (PurInf (III)): Scutellariae Radix 2.4g, Coptidis Rhizoma 1g, Phellodendri Cortex 2.4g, Gardeniae Fructus 2.4g, Houttuyniae Herba 4g, Golden Buckwheat 3g<br>* Other names: PurInf (I), PurInf (II), PurInf(III);Drug: Standard of care<br>* remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.<br>* Other names: Medications;|
| Active Comparator: Inflammation (II)<br>Cough, chest pain | Dietary Supplement: Inflammation (II)<br>* Platycodi Radix 2.4g, Peucedani Radix 2.4g, Cynanchi stauntonii Rhizoma 2.4g, Asteris Radix 2.4g, Stemonae Radix 2.4g, Lepidii Descurainiae Semen 2.4g, Plantaginis Semen 2.4g<br>* Other names: PurCo;Drug: Standard of care<br>* remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.<br>* Other names: Medications;|
| Active Comparator: Inflammation (III)<br>Metabolites Clots | Dietary Supplement: Inflammation (III)<br>* Metabolites, abnormal fluids (PurPhl): Citri reticulatae Pericarpium 1.2g, Citri grandis Exocartium rubrum 2g, Aurantii Fructus immaturu 2g, Pinelliae Rhizoma preparatum 2.4g, Arisaematis Rhizoma preparatum 2.4g, Amoni Fructus 1g, Trichosanthis Fructus 2.4g, Fritillatiae cirrhosae Bulbu 2.4g, Poria 2.4g, Rhei Radix et Rhizoma 1g Capillaries circulation disorder (PurClo): Salviae miltiorrhizae Radix 2.4g, Curcumae Radix 2.4g, Paeoniae Radix rubra 2.4g, Persicae Semen 2.4g, Carthami Flos 2.4g<br>* Other names: PurPhl, PurClo;Drug: Standard of care<br>* remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.<br>* Other names: Medications;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovering damaged organ | comparing imagen of lungs | 3 weeks | 
| inhibiting inflammation | comparing C-reactive protein (CRP) | 3 weeks | 
| preventing the antibody depositing on antigen | measuring complement: C3, C4 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitoring the antibody level | measuring immunoglobulin M (IgM), immunoglobulin G (IgG) | 6 weeks | 
| correcting reversed immunity ratio | measuring cluster of differentiation 4/cluster of differentiation 8 (CD4/CD8) | 6 weeks | 
| tracking the COVID virus marks | SARS-CoV-2 Diagnostic (Molecular or Antigen) Testing | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viral Pneumonia, Fever, Medicinal Herbs, Virus, COVID-19, Coronavirus Disease 2019, Infections, Inflammation, Immunity, Metabolite, clots, thrombus, Cough, Chest congestion