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

Phase 2

• Conditions: Coronavirus Infections; SARS (Severe Acute Respiratory Syndrome); Coronavirus Sars-Associated; COVID-19

• Registration Number: NCT05054075
• Lead Sponsor: Universidade do Porto

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.

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 Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-23
• Study Start: 2021-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15
• Primary Completion: 2022-10
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Subjects with normal physiological state or any kind of comorbidity

Exclusion Criteria

• Subjects in highly critical health state

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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
Pulmonary system	T0 - Day 1 - Baseline	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	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

Secondary Outcome Measures

Name	Time	Method
Nervous system	T0 - Day 1 - Baseline	Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Gastrointestinal system	T0 - Day 1 - Baseline	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 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	T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours	Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints

Trial Locations

Locations (2)

Instituto Politécnico de Bragança; 🇵🇹 Bragança, Portugal

ICBAS - University of Porto; 🇵🇹 Porto, Portugal