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

April 14, 2022 updated by: Jorge Pereira Machado, Universidade do Porto

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Bragança, Portugal
        • Instituto Politécnico de Bragança
      • Porto, Portugal, 4050-313
        • ICBAS - University of Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with normal physiological state or any kind of comorbidity

Exclusion Criteria:

  • Subjects in highly critical health state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Instituto Politécnico de Bragança

Investigators

  • Study Director: Jorge P Machado, PhD, ICBAS - Instituto de Ciências Biomédicas Abel Salazar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (ACTUAL)

September 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BivalveSarsCov-Protocol
  • PPA nº 117380 (REGISTRY: Provisional Patent Application (PPA) by Porto University, Portugal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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