Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19

Study Overview
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Brief Summary
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The present work proposes to find if a bio-active composite in the hemolymph or plasma of the freshwater bivalve Anodonta cygnea is able to offer immunity and specificity for meliorating the major symptoms in human SARS and COVID-19 lineage infection. The Methodology concerns in silico procedures using organic fluids from 54 bivalves (in very specific conditions) to evaluate their therapeutic effects in 6 voluntary SARS and COVID-19 infected persons with an integrative diagnosis by a computational Mora®Nova apparatus to access the basal and experimental human physiological parameters.

Detailed Description
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A deep and consistent study will be developed with an increase in the human sampling for better understanding the intervention efficacy of this intelligence medicine integrator, the Mora® Nova method. These in silico experiments when associated with the bioresonance frequencies from stimulated hemolymph compounds of the freshwater bivalve A. cygnea, may lead us to expect high plasticity and immunological potential. Obviously, additional in vitro studies in future, with adequate culture cell lineages in different conditions and with bioresonance treatment by Mora® Nova method, should also be accomplished with hemolymph/plasma interference to confirm the pertinence, and the real efficacy on SARS / COVID-19 infection as well as to clarify the respective biological mechanisms. In addition, to analyze and evaluate any specific bioactive compound from the induced hemolymph condition needs molecular experiments which can give deep structural information concerning any efficient molecule against the SARS / COVID-19 virus lineage and respective mutants. Effectively, according to current scientific opinion, the virus mutation phenomenon leads to great and problematic difficulty for maintaining the collective and human global immunization. In this case, the present Mora methodology offers a very functional, dynamic, and efficient process when combined with a biological model, as the bivalve A. cygnea, with high plasticity and eventual molecular reconstructive adaptation. This Mora procedure can extend to other immune-depressive diseases namely cancer, rheumatoid arthritis, and neurodegenerative diseases combining with respective stimulated bivalve fluids. It suggests opening a promising future perspective when applied to large human sampling as well as with in vitro cellular assays. In addition, to explore this research with in vitro cell cultures and to do the characterization and the effects from bio-compounds on similar diseases is our close objective.

Official Title
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Methodological Design for Evaluating the Immune Capacity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19 Human Infection: Intelligent Medicine Integration.

Conditions
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Coronavirus Infections, Coronavirus Sars-Associated, SARS (Severe Acute Respiratory Syndrome), COVID-19

Intervention / Treatment
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* Biological: Marine liquid and fluids
* Biological: Impregnation
* Biological: Incubation
* Biological: Manipulation
* Biological: Refrigeration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with normal physiological state or any kind of comorbidity Exclusion Criteria: Subjects in highly critical health state

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccinated<br>Subjects that received a vaccine against COVID-19 lineage virus | Biological: Marine liquid and fluids<br>* Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)<br>Biological: Impregnation<br>* SARS / COVID-19 fluid/liquid - impregnation<br>Biological: Incubation<br>* SARS / COVID-19 fluid-bivalve-incubation<br>Biological: Manipulation<br>* Bivalve Manipulation - Stress inducing<br>Biological: Refrigeration<br>* Refrigerated fluid to check for maintained response<br>|
| Experimental: Non-vaccinated<br>Subjects that did not receive a vaccine against COVID-19 lineage virus | Biological: Marine liquid and fluids<br>* Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)<br>Biological: Impregnation<br>* SARS / COVID-19 fluid/liquid - impregnation<br>Biological: Incubation<br>* SARS / COVID-19 fluid-bivalve-incubation<br>Biological: Manipulation<br>* Bivalve Manipulation - Stress inducing<br>Biological: Refrigeration<br>* Refrigerated fluid to check for maintained response<br>|
| Experimental: Infected<br>Subjects that are infected with a COVID-19 lineage virus | Biological: Marine liquid and fluids<br>* Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)<br>Biological: Impregnation<br>* SARS / COVID-19 fluid/liquid - impregnation<br>Biological: Incubation<br>* SARS / COVID-19 fluid-bivalve-incubation<br>Biological: Manipulation<br>* Bivalve Manipulation - Stress inducing<br>Biological: Refrigeration<br>* Refrigerated fluid to check for maintained response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary system | Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints | T0 - Day 1 - Baseline | 
| Pulmonary system change | Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints | T1 - Day 1 - After in silico human virus infestation | 
| Pulmonary system change | Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints | T2 - Day 1 - After adding the interface of the original fluid | 
| Pulmonary system change | Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints | T3 - Day 1 - After adding the interface of virus impregnated fluid | 
| Pulmonary system change | Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints | T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours | 
| Cardiac system | Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints | T0 - Day 1 - Baseline | 
| Cardiac system change | Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints | T1 - Day 1 - After in silico human virus infestation | 
| Cardiac system change | Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints | T2 - Day 1 - After adding the interface of the original fluid | 
| Cardiac system change | Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints | T3 - Day 1 - After adding the interface of virus impregnated fluid | 
| Cardiac system change | Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints | T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours | 
| Immunologic system | Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints | T0 - Day 1 - Baseline | 
| Immunologic system change | Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints | T1 - Day 1 - After in silico human virus infestation | 
| Immunologic system change | Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints | T2 - Day 1 - After adding the interface of the original fluid | 
| Immunologic system change | Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints | T3 - Day 1 - After adding the interface of virus impregnated fluid | 
| Immunologic system change | Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints | T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal system | Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints | T0 - Day 1 - Baseline | 
| Gastrointestinal system Change | Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints | T1 - Day 1 - After in silico human virus infestation | 
| Gastrointestinal system Change | Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints | T2 - Day 1 - After adding the interface of the original fluid | 
| Gastrointestinal system Change | Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints | T3 - Day 1 - After adding the interface of virus impregnated fluid | 
| Gastrointestinal system Change | Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints | T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours | 
| Nervous system | Voll Electromagnetic conductance reading (Hz) on nervous system biopoints | T0 - Day 1 - Baseline | 
| Nervous system change | Voll Electromagnetic conductance reading (Hz) on nervous system biopoints | T1 - Day 1 - After in silico human virus infestation | 
| Nervous system change | Voll Electromagnetic conductance reading (Hz) on nervous system biopoints | T2 - Day 1 - After adding the interface of the original fluid | 
| Nervous system change | Voll Electromagnetic conductance reading (Hz) on nervous system biopoints | T3 - Day 1 - After adding the interface of virus impregnated fluid | 
| Nervous system change | Voll Electromagnetic conductance reading (Hz) on nervous system biopoints | T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours | 
| Endocrine system | Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints | T0 - Day 1 - Baseline | 
| Endocrine system change | Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints | T1 - Day 1 - After in silico human virus infestation | 
| Endocrine system change | Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints | T2 - Day 1 - After adding the interface of the original fluid | 
| Endocrine system change | Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints | T3 - Day 1 - After adding the interface of virus impregnated fluid | 
| Endocrine system change | Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints | T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours |