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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05054075
• Other study ID #: BivalveSarsCov-Protocol
• Secondary ID: PPA nº 117380
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: November 2022

Study information

• Verified date: April 2022
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: November 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Subjects with normal physiological state or any kind of comorbidity

Exclusion Criteria:

• Subjects in highly critical health state

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Infections
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• Marine liquid and fluids
Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)
• Impregnation
SARS / COVID-19 fluid/liquid - impregnation
• Incubation
SARS / COVID-19 fluid-bivalve-incubation
• Manipulation
Bivalve Manipulation - Stress inducing
• Refrigeration
Refrigerated fluid to check for maintained response

Locations

Country	Name	City	State
Portugal	Instituto Politécnico de Bragança	Bragança
Portugal	ICBAS - University of Porto	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Instituto Politécnico de Bragança

Country where clinical trial is conducted

Portugal, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary system	Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints	T0 - Day 1 - Baseline
Primary	Pulmonary system change	Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints	T1 - Day 1 - After in silico human virus infestation
Primary	Pulmonary system change	Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints	T2 - Day 1 - After adding the interface of the original fluid
Primary	Pulmonary system change	Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints	T3 - Day 1 - After adding the interface of virus impregnated fluid
Primary	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
Primary	Cardiac system	Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints	T0 - Day 1 - Baseline
Primary	Cardiac system change	Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints	T1 - Day 1 - After in silico human virus infestation
Primary	Cardiac system change	Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints	T2 - Day 1 - After adding the interface of the original fluid
Primary	Cardiac system change	Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints	T3 - Day 1 - After adding the interface of virus impregnated fluid
Primary	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
Primary	Immunologic system	Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints	T0 - Day 1 - Baseline
Primary	Immunologic system change	Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints	T1 - Day 1 - After in silico human virus infestation
Primary	Immunologic system change	Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints	T2 - Day 1 - After adding the interface of the original fluid
Primary	Immunologic system change	Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints	T3 - Day 1 - After adding the interface of virus impregnated fluid
Primary	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	Gastrointestinal system	Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints	T0 - Day 1 - Baseline
Secondary	Gastrointestinal system Change	Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints	T1 - Day 1 - After in silico human virus infestation
Secondary	Gastrointestinal system Change	Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints	T2 - Day 1 - After adding the interface of the original fluid
Secondary	Gastrointestinal system Change	Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints	T3 - Day 1 - After adding the interface of virus impregnated fluid
Secondary	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
Secondary	Nervous system	Voll Electromagnetic conductance reading (Hz) on nervous system biopoints	T0 - Day 1 - Baseline
Secondary	Nervous system change	Voll Electromagnetic conductance reading (Hz) on nervous system biopoints	T1 - Day 1 - After in silico human virus infestation
Secondary	Nervous system change	Voll Electromagnetic conductance reading (Hz) on nervous system biopoints	T2 - Day 1 - After adding the interface of the original fluid
Secondary	Nervous system change	Voll Electromagnetic conductance reading (Hz) on nervous system biopoints	T3 - Day 1 - After adding the interface of virus impregnated fluid
Secondary	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
Secondary	Endocrine system	Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints	T0 - Day 1 - Baseline
Secondary	Endocrine system change	Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints	T1 - Day 1 - After in silico human virus infestation
Secondary	Endocrine system change	Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints	T2 - Day 1 - After adding the interface of the original fluid
Secondary	Endocrine system change	Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints	T3 - Day 1 - After adding the interface of virus impregnated fluid
Secondary	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