Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19
Primary Purpose
Coronavirus Infections, Coronavirus Sars-Associated, SARS (Severe Acute Respiratory Syndrome)
Status
Enrolling by invitation
Phase
Phase 2
Locations
Portugal
Study Type
Interventional
Intervention
Marine liquid and fluids
Impregnation
Incubation
Manipulation
Refrigeration
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Infections
Eligibility Criteria
Inclusion Criteria:
- Subjects with normal physiological state or any kind of comorbidity
Exclusion Criteria:
- Subjects in highly critical health state
Sites / Locations
- Instituto Politécnico de Bragança
- ICBAS - University of Porto
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Vaccinated
Non-vaccinated
Infected
Arm Description
Subjects that received a vaccine against COVID-19 lineage virus
Subjects that did not receive a vaccine against COVID-19 lineage virus
Subjects that are infected with a COVID-19 lineage virus
Outcomes
Primary Outcome Measures
Pulmonary system
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Cardiac system
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Immunologic system
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Secondary Outcome Measures
Gastrointestinal system
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Nervous system
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Endocrine system
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Full Information
NCT ID
NCT05054075
First Posted
August 3, 2021
Last Updated
April 14, 2022
Sponsor
Universidade do Porto
Collaborators
Instituto Politécnico de Bragança
1. Study Identification
Unique Protocol Identification Number
NCT05054075
Brief Title
Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
Collaborators
Instituto Politécnico de Bragança
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections, Coronavirus Sars-Associated, SARS (Severe Acute Respiratory Syndrome), COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaccinated
Arm Type
Experimental
Arm Description
Subjects that received a vaccine against COVID-19 lineage virus
Arm Title
Non-vaccinated
Arm Type
Experimental
Arm Description
Subjects that did not receive a vaccine against COVID-19 lineage virus
Arm Title
Infected
Arm Type
Experimental
Arm Description
Subjects that are infected with a COVID-19 lineage virus
Intervention Type
Biological
Intervention Name(s)
Marine liquid and fluids
Intervention Description
Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)
Intervention Type
Biological
Intervention Name(s)
Impregnation
Intervention Description
SARS / COVID-19 fluid/liquid - impregnation
Intervention Type
Biological
Intervention Name(s)
Incubation
Intervention Description
SARS / COVID-19 fluid-bivalve-incubation
Intervention Type
Biological
Intervention Name(s)
Manipulation
Intervention Description
Bivalve Manipulation - Stress inducing
Intervention Type
Biological
Intervention Name(s)
Refrigeration
Intervention Description
Refrigerated fluid to check for maintained response
Primary Outcome Measure Information:
Title
Pulmonary system
Description
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Time Frame
T0 - Day 1 - Baseline
Title
Pulmonary system change
Description
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Time Frame
T1 - Day 1 - After in silico human virus infestation
Title
Pulmonary system change
Description
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Time Frame
T2 - Day 1 - After adding the interface of the original fluid
Title
Pulmonary system change
Description
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Time Frame
T3 - Day 1 - After adding the interface of virus impregnated fluid
Title
Pulmonary system change
Description
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Time Frame
T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Title
Cardiac system
Description
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Time Frame
T0 - Day 1 - Baseline
Title
Cardiac system change
Description
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Time Frame
T1 - Day 1 - After in silico human virus infestation
Title
Cardiac system change
Description
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Time Frame
T2 - Day 1 - After adding the interface of the original fluid
Title
Cardiac system change
Description
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Time Frame
T3 - Day 1 - After adding the interface of virus impregnated fluid
Title
Cardiac system change
Description
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Time Frame
T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Title
Immunologic system
Description
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Time Frame
T0 - Day 1 - Baseline
Title
Immunologic system change
Description
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Time Frame
T1 - Day 1 - After in silico human virus infestation
Title
Immunologic system change
Description
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Time Frame
T2 - Day 1 - After adding the interface of the original fluid
Title
Immunologic system change
Description
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Time Frame
T3 - Day 1 - After adding the interface of virus impregnated fluid
Title
Immunologic system change
Description
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Time Frame
T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Secondary Outcome Measure Information:
Title
Gastrointestinal system
Description
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Time Frame
T0 - Day 1 - Baseline
Title
Gastrointestinal system Change
Description
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Time Frame
T1 - Day 1 - After in silico human virus infestation
Title
Gastrointestinal system Change
Description
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Time Frame
T2 - Day 1 - After adding the interface of the original fluid
Title
Gastrointestinal system Change
Description
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Time Frame
T3 - Day 1 - After adding the interface of virus impregnated fluid
Title
Gastrointestinal system Change
Description
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Time Frame
T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Title
Nervous system
Description
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Time Frame
T0 - Day 1 - Baseline
Title
Nervous system change
Description
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Time Frame
T1 - Day 1 - After in silico human virus infestation
Title
Nervous system change
Description
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Time Frame
T2 - Day 1 - After adding the interface of the original fluid
Title
Nervous system change
Description
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Time Frame
T3 - Day 1 - After adding the interface of virus impregnated fluid
Title
Nervous system change
Description
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Time Frame
T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Title
Endocrine system
Description
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Time Frame
T0 - Day 1 - Baseline
Title
Endocrine system change
Description
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Time Frame
T1 - Day 1 - After in silico human virus infestation
Title
Endocrine system change
Description
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Time Frame
T2 - Day 1 - After adding the interface of the original fluid
Title
Endocrine system change
Description
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Time Frame
T3 - Day 1 - After adding the interface of virus impregnated fluid
Title
Endocrine system change
Description
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Time Frame
T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with normal physiological state or any kind of comorbidity
Exclusion Criteria:
Subjects in highly critical health state
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge P Machado, PhD
Organizational Affiliation
ICBAS - Instituto de Ciências Biomédicas Abel Salazar
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Politécnico de Bragança
City
Bragança
Country
Portugal
Facility Name
ICBAS - University of Porto
City
Porto
ZIP/Postal Code
4050-313
Country
Portugal
12. IPD Sharing Statement
Citations:
PubMed Identifier
20349058
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.
Results Reference
background
PubMed Identifier
32668444
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.
Results Reference
background
PubMed Identifier
26003824
Citation
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.
Results Reference
background
PubMed Identifier
29547519
Citation
Green TJ, Speck P. Antiviral Defense and Innate Immune Memory in the Oyster. Viruses. 2018 Mar 16;10(3):133. doi: 10.3390/v10030133.
Results Reference
background
PubMed Identifier
32198501
Citation
Guo L, Ren L, Yang S, Xiao M, Chang D, 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.
Results Reference
background
PubMed Identifier
31676427
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.
Results Reference
background
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Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19
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