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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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