Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vaccinated Subjects that received a vaccine against COVID-19 lineage virus |
Biological: Marine liquid and fluids
Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)
Biological: Impregnation
SARS / COVID-19 fluid/liquid - impregnation
Biological: Incubation
SARS / COVID-19 fluid-bivalve-incubation
Biological: Manipulation
Bivalve Manipulation - Stress inducing
Biological: Refrigeration
Refrigerated fluid to check for maintained response
|
| Experimental: Non-vaccinated Subjects that did not receive a vaccine against COVID-19 lineage virus |
Biological: Marine liquid and fluids
Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)
Biological: Impregnation
SARS / COVID-19 fluid/liquid - impregnation
Biological: Incubation
SARS / COVID-19 fluid-bivalve-incubation
Biological: Manipulation
Bivalve Manipulation - Stress inducing
Biological: Refrigeration
Refrigerated fluid to check for maintained response
|
| Experimental: Infected Subjects that are infected with a COVID-19 lineage virus |
Biological: Marine liquid and fluids
Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)
Biological: Impregnation
SARS / COVID-19 fluid/liquid - impregnation
Biological: Incubation
SARS / COVID-19 fluid-bivalve-incubation
Biological: Manipulation
Bivalve Manipulation - Stress inducing
Biological: Refrigeration
Refrigerated fluid to check for maintained response
|
Outcome Measures
Primary Outcome Measures
- Pulmonary system [T0 - Day 1 - Baseline]
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
- Pulmonary system change [T1 - Day 1 - After in silico human virus infestation]
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
- Pulmonary system change [T2 - Day 1 - After adding the interface of the original fluid]
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
- Pulmonary system change [T3 - Day 1 - After adding the interface of virus impregnated fluid]
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
- Pulmonary system change [T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours]
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
- Cardiac system [T0 - Day 1 - Baseline]
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
- Cardiac system change [T1 - Day 1 - After in silico human virus infestation]
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
- Cardiac system change [T2 - Day 1 - After adding the interface of the original fluid]
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
- Cardiac system change [T3 - Day 1 - After adding the interface of virus impregnated fluid]
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
- Cardiac system change [T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours]
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
- Immunologic system [T0 - Day 1 - Baseline]
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
- Immunologic system change [T1 - Day 1 - After in silico human virus infestation]
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
- Immunologic system change [T2 - Day 1 - After adding the interface of the original fluid]
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
- Immunologic system change [T3 - Day 1 - After adding the interface of virus impregnated fluid]
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
- Immunologic system change [T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours]
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Secondary Outcome Measures
- Gastrointestinal system [T0 - Day 1 - Baseline]
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
- Gastrointestinal system Change [T1 - Day 1 - After in silico human virus infestation]
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
- Gastrointestinal system Change [T2 - Day 1 - After adding the interface of the original fluid]
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
- Gastrointestinal system Change [T3 - Day 1 - After adding the interface of virus impregnated fluid]
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
- Gastrointestinal system Change [T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours]
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
- Nervous system [T0 - Day 1 - Baseline]
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
- Nervous system change [T1 - Day 1 - After in silico human virus infestation]
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
- Nervous system change [T2 - Day 1 - After adding the interface of the original fluid]
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
- Nervous system change [T3 - Day 1 - After adding the interface of virus impregnated fluid]
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
- Nervous system change [T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours]
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
- Endocrine system [T0 - Day 1 - Baseline]
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
- Endocrine system change [T1 - Day 1 - After in silico human virus infestation]
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
- Endocrine system change [T2 - Day 1 - After adding the interface of the original fluid]
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
- Endocrine system change [T3 - Day 1 - After adding the interface of virus impregnated fluid]
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
- Endocrine system change [T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours]
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects with normal physiological state or any kind of comorbidity
Exclusion Criteria:
- Subjects in highly critical health state
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto Politécnico de Bragança | Bragança | Portugal | ||
| 2 | ICBAS - University of Porto | Porto | Portugal | 4050-313 |
Sponsors and Collaborators
- Universidade do Porto
- Instituto Politécnico de Bragança
Investigators
- Study Director: Jorge P Machado, PhD, ICBAS - Instituto de Ciências Biomédicas Abel Salazar
Study Documents (Full-Text)
None provided.More Information
Publications
- Allam B, Raftos D. Immune responses to infectious diseases in bivalves. J Invertebr Pathol. 2015 Oct;131:121-36. doi: 10.1016/j.jip.2015.05.005. Epub 2015 May 21. Review.
- Antunes F, Hinzmann M, Lopes-Lima M, Machado J, Martins da Costa P. Association between environmental microbiota and indigenous bacteria found in hemolymph, extrapallial fluid and mucus of Anodonta cygnea (Linnaeus, 1758). Microb Ecol. 2010 Aug;60(2):304-9. doi: 10.1007/s00248-010-9649-y. Epub 2010 Mar 27.
- Green TJ, Speck P. Antiviral Defense and Innate Immune Memory in the Oyster. Viruses. 2018 Mar 16;10(3). pii: E133. doi: 10.3390/v10030133. Review.
- Guo L, Ren L, Yang S, Xiao M, Chang, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
- Le Bert N, Tan AT, Kunasegaran K, Tham CYL, Hafezi M, Chia A, Chng MHY, Lin M, Tan N, Linster M, Chia WN, Chen MI, Wang LF, Ooi EE, Kalimuddin S, Tambyah PA, Low JG, Tan YJ, Bertoletti A. SARS-CoV-2-specific T cell immunity in cases of COVID-19 and SARS, and uninfected controls. Nature. 2020 Aug;584(7821):457-462. doi: 10.1038/s41586-020-2550-z. Epub 2020 Jul 15.
- Sousa H, Hinzmann M. Review: Antibacterial components of the Bivalve's immune system and the potential of freshwater bivalves as a source of new antibacterial compounds. Fish Shellfish Immunol. 2020 Mar;98:971-980. doi: 10.1016/j.fsi.2019.10.062. Epub 2019 Oct 30. Review.
- BivalveSarsCov-Protocol
- PPA nº 117380