Coronavirus InfectionsPhase 2NCT05054075
Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19
A Phase 2 study testing Marine liquid and fluids, Impregnation and Incubation in people with Coronavirus Infections and Coronavirus Sars-Associated, run by Universidade do Porto at 2 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections, Coronavirus Sars-Associated, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- Marine liquid and fluids, Impregnation and Incubation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Oct 2021to Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects with normal physiological state or any kind of comorbidity
Who cannot join
- Subjects in highly critical health state
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Instituto Politécnico de Bragança
Bragança
ICBAS - University of Porto
Porto, 4050-313
About this study
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.
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.
Read the 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.
- Conditions
- Coronavirus Infections, Coronavirus Sars-Associated, SARS (Severe Acute Respiratory Syndrome), COVID-19
- Being tested
- Marine liquid and fluids, Impregnation, Incubation, Manipulation, Refrigeration
- Medical subject headings
- Coronavirus Infections, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marine liquid and fluidsBiological
Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)
ImpregnationBiological
SARS / COVID-19 fluid/liquid - impregnation
IncubationBiological
SARS / COVID-19 fluid-bivalve-incubation
ManipulationBiological
Bivalve Manipulation - Stress inducing
RefrigerationBiological
Refrigerated fluid to check for maintained response
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Experimental | Subjects that received a vaccine against COVID-19 lineage virus Receives: Biological: Marine liquid and fluids; Biological: Impregnation; Biological: Incubation; Biological: Manipulation; Biological: Refrigeration |
| Non-vaccinated | Experimental | Subjects that did not receive a vaccine against COVID-19 lineage virus Receives: Biological: Marine liquid and fluids; Biological: Impregnation; Biological: Incubation; Biological: Manipulation; Biological: Refrigeration |
| Infected | Experimental | Subjects that are infected with a COVID-19 lineage virus Receives: Biological: Marine liquid and fluids; Biological: Impregnation; Biological: Incubation; Biological: Manipulation; Biological: Refrigeration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary system
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Measured: T0 - Day 1 - Baseline
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Measured: T1 - Day 1 - After in silico human virus infestation
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Measured: T2 - Day 1 - After adding the interface of the original fluid
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Measured: T3 - Day 1 - After adding the interface of virus impregnated fluid
Pulmonary system change
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Measured: 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
Measured: T0 - Day 1 - Baseline
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Measured: T1 - Day 1 - After in silico human virus infestation
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Measured: T2 - Day 1 - After adding the interface of the original fluid
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Measured: T3 - Day 1 - After adding the interface of virus impregnated fluid
Cardiac system change
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Measured: 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
Measured: T0 - Day 1 - Baseline
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Measured: T1 - Day 1 - After in silico human virus infestation
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Measured: T2 - Day 1 - After adding the interface of the original fluid
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Measured: T3 - Day 1 - After adding the interface of virus impregnated fluid
Immunologic system change
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Measured: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Secondary outcomes (15)
Gastrointestinal system
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Measured: T0 - Day 1 - Baseline
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Measured: T1 - Day 1 - After in silico human virus infestation
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Measured: T2 - Day 1 - After adding the interface of the original fluid
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Measured: T3 - Day 1 - After adding the interface of virus impregnated fluid
Gastrointestinal system Change
Voll Electromagnetic conductance reading (Hz) on gastrointestinal system biopoints
Measured: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Nervous system
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Measured: T0 - Day 1 - Baseline
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Measured: T1 - Day 1 - After in silico human virus infestation
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Measured: T2 - Day 1 - After adding the interface of the original fluid
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Measured: T3 - Day 1 - After adding the interface of virus impregnated fluid
Nervous system change
Voll Electromagnetic conductance reading (Hz) on nervous system biopoints
Measured: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Endocrine system
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Measured: T0 - Day 1 - Baseline
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Measured: T1 - Day 1 - After in silico human virus infestation
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Measured: T2 - Day 1 - After adding the interface of the original fluid
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Measured: T3 - Day 1 - After adding the interface of virus impregnated fluid
Endocrine system change
Voll Electromagnetic conductance reading (Hz) on endocrine system biopoints
Measured: T4 - Day 3 - After adding the interface of virus incubated fluid during 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Oct 2021
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Bragança
- Responsible party
- Principal investigator, Jorge Pereira Machado, Universidade do Porto
- Investigators
- Jorge P Machado, PhD, Study director, ICBAS - Instituto de Ciências Biomédicas Abel Salazar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054075
- Sponsor's protocol ID
- BivalveSarsCov-Protocol
- Other IDs
- PPA nº 117380
- Status last verified
- Apr 2022
- First submitted
- 3 Aug 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20349058Le 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.
PubMed 32668444Allam 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.
PubMed 26003824Green TJ, Speck P. Antiviral Defense and Innate Immune Memory in the Oyster. Viruses. 2018 Mar 16;10(3):133. doi: 10.3390/v10030133.
PubMed 29547519Guo 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.
PubMed 32198501Sousa 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.
PubMed 31676427
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05054075
- Acronym / sponsor ID
- BivalveSarsCov-Protocol
- Conditions
- Coronavirus Infections, Coronavirus Sars-Associated, SARS (Severe Acute Respiratory Syndrome), COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Instituto Politécnico de Bragança
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | Experimental | Biological: Marine liquid and fluids, Biological: Impregnation, Biological: Incubation, Biological: Manipulation, Biological: RefrigerationSubjects that received a vaccine against COVID-19 lineage virus |
| Non-vaccinated | Experimental | Biological: Marine liquid and fluids, Biological: Impregnation, Biological: Incubation, Biological: Manipulation, Biological: RefrigerationSubjects that did not receive a vaccine against COVID-19 lineage virus |
| Infected | Experimental | Biological: Marine liquid and fluids, Biological: Impregnation, Biological: Incubation, Biological: Manipulation, Biological: RefrigerationSubjects that are infected with a COVID-19 lineage virus |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with normal physiological state or any kind of comorbidity
Key exclusion criteria (1 listed)
- Subjects in highly critical health state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marine liquid and fluidsMarine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions) | Biological | Infected, Non-vaccinated, Vaccinated |
| ImpregnationSARS / COVID-19 fluid/liquid - impregnation | Biological | Infected, Non-vaccinated, Vaccinated |
| IncubationSARS / COVID-19 fluid-bivalve-incubation | Biological | Infected, Non-vaccinated, Vaccinated |
| ManipulationBivalve Manipulation - Stress inducing | Biological | Infected, Non-vaccinated, Vaccinated |
| RefrigerationRefrigerated fluid to check for maintained response | Biological | Infected, Non-vaccinated, Vaccinated |
Primary outcome
Pulmonary system
Time frame: T0 - Day 1 - Baseline
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
Pulmonary system change
Time frame: T1 - Day 1 - After in silico human virus infestation
Voll Electromagnetic conductance reading (Hz) on pulmonary system biopoints
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
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
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
Cardiac system
Time frame: T0 - Day 1 - Baseline
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
Cardiac system change
Time frame: T1 - Day 1 - After in silico human virus infestation
Voll Electromagnetic conductance reading (Hz) on cardiac system biopoints
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
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
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
Immunologic system
Time frame: T0 - Day 1 - Baseline
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
Immunologic system change
Time frame: T1 - Day 1 - After in silico human virus infestation
Voll Electromagnetic conductance reading (Hz) on immunologic system biopoints
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
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
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
15 secondary outcomes
Gastrointestinal system
Time frame: T0 - Day 1 - Baseline
Gastrointestinal system Change
Time frame: 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
Gastrointestinal system Change
Time frame: 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
Nervous system
Time frame: T0 - Day 1 - Baseline
Nervous system change
Time frame: 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
Nervous system change
Time frame: 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
Endocrine system
Time frame: T0 - Day 1 - Baseline
Endocrine system change
Time frame: 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
Endocrine system change
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 20349058Antunes 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.
- Background: PubMed 32668444Le 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.
- Background: PubMed 26003824Allam 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.
- Background: PubMed 29547519Green TJ, Speck P. Antiviral Defense and Innate Immune Memory in the Oyster. Viruses. 2018 Mar 16;10(3):133. doi: 10.3390/v10030133.
- Background: PubMed 32198501Guo 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.
- Background: PubMed 31676427Sousa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge P Machado, PhD study director
ICBAS - Instituto de Ciências Biomédicas Abel Salazar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Marine liquid and fluids, Impregnation and Incubation in people with Coronavirus Infections and Coronavirus Sars-Associated, run by Universidade do Porto at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary system (time frame: T0 - Day 1 - Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054075, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.