Clinical trial NCT05054075: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronavirus Infections
Coronavirus Sars-Associated
SARS (Severe Acute Respiratory Syndrome)
COVID-19
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Instituto Politécnico de Bragança
First posted: 2021-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Subjects with normal physiological state or any kind of comorbidity

Exclusion Criteria:

* Subjects in highly critical health state

Primary outcomes:
measure: Pulmonary system
timeFrame: T0 - Day 1 - Baseline
measure: Pulmonary system change
timeFrame: T1 - Day 1 - After in silico human virus infestation
measure: Pulmonary system change
timeFrame: T2 - Day 1 - After adding the interface of the original fluid
measure: Pulmonary system change
timeFrame: T3 - Day 1 - After adding the interface of virus impregnated fluid
measure: Pulmonary system change
timeFrame: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
measure: Cardiac system
timeFrame: T0 - Day 1 - Baseline
measure: Cardiac system change
timeFrame: T1 - Day 1 - After in silico human virus infestation
measure: Cardiac system change
timeFrame: T2 - Day 1 - After adding the interface of the original fluid
measure: Cardiac system change
timeFrame: T3 - Day 1 - After adding the interface of virus impregnated fluid
measure: Cardiac system change
timeFrame: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
measure: Immunologic system
timeFrame: T0 - Day 1 - Baseline
measure: Immunologic system change
timeFrame: T1 - Day 1 - After in silico human virus infestation
measure: Immunologic system change
timeFrame: T2 - Day 1 - After adding the interface of the original fluid
measure: Immunologic system change
timeFrame: T3 - Day 1 - After adding the interface of virus impregnated fluid
measure: Immunologic system change
timeFrame: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Secondary outcomes:
measure: Gastrointestinal system
timeFrame: T0 - Day 1 - Baseline
measure: Gastrointestinal system Change
timeFrame: T1 - Day 1 - After in silico human virus infestation
measure: Gastrointestinal system Change
timeFrame: T2 - Day 1 - After adding the interface of the original fluid
measure: Gastrointestinal system Change
timeFrame: T3 - Day 1 - After adding the interface of virus impregnated fluid
measure: Gastrointestinal system Change
timeFrame: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
measure: Nervous system
timeFrame: T0 - Day 1 - Baseline
measure: Nervous system change
timeFrame: T1 - Day 1 - After in silico human virus infestation
measure: Nervous system change
timeFrame: T2 - Day 1 - After adding the interface of the original fluid
measure: Nervous system change
timeFrame: T3 - Day 1 - After adding the interface of virus impregnated fluid
measure: Nervous system change
timeFrame: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
measure: Endocrine system
timeFrame: T0 - Day 1 - Baseline
measure: Endocrine system change
timeFrame: T1 - Day 1 - After in silico human virus infestation
measure: Endocrine system change
timeFrame: T2 - Day 1 - After adding the interface of the original fluid
measure: Endocrine system change
timeFrame: T3 - Day 1 - After adding the interface of virus impregnated fluid
measure: Endocrine system change
timeFrame: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Other outcomes:
Locations:
city: Bragança
country: Portugal
facility: Instituto Politécnico de Bragança
city: Porto
country: Portugal
facility: ICBAS - University of Porto
Study officials:
affiliation: ICBAS - Instituto de Ciências Biomédicas Abel Salazar
name: Jorge P Machado, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.