NCT05054075

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

August 3, 2021

Last Update Submit

April 14, 2022

Conditions

Coronavirus InfectionsCoronavirus Sars-AssociatedSARS (Severe Acute Respiratory Syndrome)COVID-19

Outcome Measures

Primary Outcomes (15)

  • Pulmonary system

    Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints

    T0 - Day 1 - Baseline

  • Pulmonary system change

    Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints

    T1 - Day 1 - After in silico human virus infestation

  • Pulmonary system change

    Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints

    T2 - Day 1 - After adding the interface of the original fluid

  • Pulmonary system change

    Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints

    T3 - Day 1 - After adding the interface of virus impregnated fluid

  • 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

  • Cardiac system

    Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints

    T0 - Day 1 - Baseline

  • Cardiac system change

    Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints

    T1 - Day 1 - After in silico human virus infestation

  • Cardiac system change

    Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints

    T2 - Day 1 - After adding the interface of the original fluid

  • Cardiac system change

    Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints

    T3 - Day 1 - After adding the interface of virus impregnated fluid

  • 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

  • Immunologic system

    Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints

    T0 - Day 1 - Baseline

  • Immunologic system change

    Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints

    T1 - Day 1 - After in silico human virus infestation

  • Immunologic system change

    Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints

    T2 - Day 1 - After adding the interface of the original fluid

  • Immunologic system change

    Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints

    T3 - Day 1 - After adding the interface of virus impregnated fluid

  • 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 Outcomes (15)

  • Gastrointestinal system

    T0 - Day 1 - Baseline

  • Gastrointestinal system Change

    T1 - Day 1 - After in silico human virus infestation

  • Gastrointestinal system Change

    T2 - Day 1 - After adding the interface of the original fluid

  • Gastrointestinal system Change

    T3 - Day 1 - After adding the interface of virus impregnated fluid

  • Gastrointestinal system Change

    T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours

  • +10 more secondary outcomes

Study Arms (3)

Vaccinated

EXPERIMENTAL

Subjects that received a vaccine against COVID-19 lineage virus

Biological: Marine liquid and fluidsBiological: ImpregnationBiological: IncubationBiological: ManipulationBiological: Refrigeration

Non-vaccinated

EXPERIMENTAL

Subjects that did not receive a vaccine against COVID-19 lineage virus

Biological: Marine liquid and fluidsBiological: ImpregnationBiological: IncubationBiological: ManipulationBiological: Refrigeration

Infected

EXPERIMENTAL

Subjects that are infected with a COVID-19 lineage virus

Biological: Marine liquid and fluidsBiological: ImpregnationBiological: IncubationBiological: ManipulationBiological: Refrigeration

Interventions

Marine liquid and fluidsBIOLOGICAL

Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)

InfectedNon-vaccinatedVaccinated
ImpregnationBIOLOGICAL

SARS / COVID-19 fluid/liquid - impregnation

InfectedNon-vaccinatedVaccinated
IncubationBIOLOGICAL

SARS / COVID-19 fluid-bivalve-incubation

InfectedNon-vaccinatedVaccinated
ManipulationBIOLOGICAL

Bivalve Manipulation - Stress inducing

InfectedNon-vaccinatedVaccinated
RefrigerationBIOLOGICAL

Refrigerated fluid to check for maintained response

InfectedNon-vaccinatedVaccinated

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with normal physiological state or any kind of comorbidity

You may not qualify if:

  • Subjects in highly critical health state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Politécnico de Bragança

Bragança, Portugal

Location

ICBAS - University of Porto

Porto, 4050-313, Portugal

Location

Related Publications (6)

  • 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.

    PMID: 20349058BACKGROUND

  • 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.

    PMID: 32668444BACKGROUND

  • 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.

    PMID: 26003824BACKGROUND

  • Green TJ, Speck P. Antiviral Defense and Innate Immune Memory in the Oyster. Viruses. 2018 Mar 16;10(3):133. doi: 10.3390/v10030133.

    PMID: 29547519BACKGROUND

  • 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.

    PMID: 32198501BACKGROUND

  • 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.

    PMID: 31676427BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsSevere Acute Respiratory SyndromeCOVID-19

Interventions

Fluid TherapyFertilizationInfectious Disease Incubation PeriodRefrigeration

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaDisease Transmission, InfectiousPublic HealthEnvironment and Public HealthPreservation, BiologicalInvestigative Techniques

Study Officials

  • Jorge P Machado, PhD

    ICBAS - Instituto de Ciências Biomédicas Abel Salazar

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2021

First Posted

September 23, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

PT(2)