COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A
NCT ID: NCT05531019
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2021-09-22
2022-12-18
Brief Summary
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Detailed Description
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The main objetivec behind this clinical trial is to diminish ROS in the cells, enhance gluthation pathways and diminish cellular inflammation. Echinochrome A is a powerfull marine poliphenol with known antioxidant activity found in the eggs, shells and spines of sea urchins, that had been use in eastern medicien for a long time. Powder of sea urchin eggs are mention in Materia Medica back far 1647 as a powerfull anti inflamation agent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dietary Supplement with sea urchin egg extract
Ingestion of dietary supplement with 0,025% of Echinochrome A (ingested 3ml twice a day for 90 days), 1,5mg daily consumption from sea urchin egg extract (Arbacia dufresnii)
Echinochrome A
Dietary Supplement with Echinochroma A Simple randomized design, in this arm patients will take 6ml of a 0.025% Echinochroma A solution twice a day for 90 days. 3 mg of Echinochroma A will be consumed per day.
Control
Ingestion of 3ml twice a day for 90 days of placebo
Control
Simple randomized design, in this arm patients will take 6ml of an fructose aqueous solution twice a day for 90 days with the same flavor as the treatment
Interventions
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Echinochrome A
Dietary Supplement with Echinochroma A Simple randomized design, in this arm patients will take 6ml of a 0.025% Echinochroma A solution twice a day for 90 days. 3 mg of Echinochroma A will be consumed per day.
Control
Simple randomized design, in this arm patients will take 6ml of an fructose aqueous solution twice a day for 90 days with the same flavor as the treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of COVID Persistent, COVID sequalea, Long COVID
3. Adult men or non-pregnant adult women between the ages of 18 and 60.
4. The patient (or legally authorized representative) provides your informed consent before initiating any study procedure.
5. The patient (or legally authorized representative) understands and agrees comply with the planned study procedures. 6. Agreement not to participate in another trial ofintervention for the treatment of COVID-19 until day 60 after the start of the trial.
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Universidad Nacional de la Patagonia San Juan Bosco
UNKNOWN
Ministerio de Ciencia, Tecnologia e Innovación, Argentina
UNKNOWN
Hospital de Infecciosas Francisco Javier Muniz
OTHER_GOV
Fernando Saldarini
OTHER
Responsible Party
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Fernando Saldarini
Head of Neumology
Principal Investigators
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Tamara Rubilar, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Nacional de la Patagonia San Juan Bosco
Locations
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Hospital Donación Francisco Santojanni
Buenos Aires, , Argentina
Countries
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References
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Gorna R, MacDermott N, Rayner C, O'Hara M, Evans S, Agyen L, Nutland W, Rogers N, Hastie C. Long COVID guidelines need to reflect lived experience. Lancet. 2021 Feb 6;397(10273):455-457. doi: 10.1016/S0140-6736(20)32705-7. Epub 2020 Dec 23. No abstract available.
Marshall M. The four most urgent questions about long COVID. Nature. 2021 Jun;594(7862):168-170. doi: 10.1038/d41586-021-01511-z. No abstract available.
COVID-19 rapid guideline: managing the long-term effects of COVID-19. London: National Institute for Health and Care Excellence (NICE); 2024 Jan 25. Available from http://www.ncbi.nlm.nih.gov/books/NBK567261/
S.E. de M.G. y de F. (SEMG), Guía clínica para la atención al paciente long COVID/COVID persistente, (2021) 1-12
Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
D. Barron, Bringing the Clinical Trial to the Patient, Eye Pharma. (2017)
Rubilar T, Barbieri ES, Gazquez A, Avaro M. Sea Urchin Pigments: Echinochrome A and Its Potential Implication in the Cytokine Storm Syndrome. Mar Drugs. 2021 May 11;19(5):267. doi: 10.3390/md19050267.
Artyukov AA, Zelepuga EA, Bogdanovich LN, Lupach NM, Novikov VL, Rutckova TA, Kozlovskaya EP. Marine Polyhydroxynaphthoquinone, Echinochrome A: Prevention of Atherosclerotic Inflammation and Probable Molecular Targets. J Clin Med. 2020 May 15;9(5):1494. doi: 10.3390/jcm9051494.
Nabavi N. Long covid: How to define it and how to manage it. BMJ. 2020 Sep 7;370:m3489. doi: 10.1136/bmj.m3489. No abstract available.
Mahase E. Long covid could be four different syndromes, review suggests. BMJ. 2020 Oct 14;371:m3981. doi: 10.1136/bmj.m3981. No abstract available.
Altmann DM, Boyton RJ. Decoding the unknowns in long covid. BMJ. 2021 Feb 4;372:n132. doi: 10.1136/bmj.n132. No abstract available.
Del Rio C, Collins LF, Malani P. Long-term Health Consequences of COVID-19. JAMA. 2020 Nov 3;324(17):1723-1724. doi: 10.1001/jama.2020.19719. No abstract available.
P. Brito-Zerón, L. Conangla Ferrín, B. Kostov, A. Moragas Moreno, M. Ramos-Casals, E. Sequeira Aymar, A. Sisó Almirall, Manfestaciones persistentes de la COVID-19 . Guía de práctica clínica, 2020.
A.A. Artyukov, A.M. Popov, A. V. Tsybulsky, O.N. Krivoshapko, N. V. Polyakova, Pharmacological activity of echinochrome a alone and in the biologically active additive Timarin, Biochem. Suppl. Ser. B Biomed. Chem. (2013). https://doi.org/10.1134/S1990750813030025.
N. Vinod, Living with 'Long COVID-19': The long-term complications and sequelae, Int. J. Clin. Virol. 5 (2021) 011-021. https://doi.org/10.29328/journal.ijcv.1001030.
A.N. Shikov, O.N. Pozharitskaya, A.S. Krishtopina, V.G. Makarov, Naphthoquinone pigments from sea urchins: chemistry and pharmacology, Phytochem. Rev. (2018). https://doi.org/10.1007/s11101-018-9547-3
C.S. Yoon, H.K. Kim, N.P. Mishchenko, E.A. Vasileva, S.A. Fedoreyev, O.P. Shestak, N.N. Balaneva, V.L. Novikov, V.A. Stonik, J. Han, The protective effects of echinochrome A structural analogs against oxidative stress and doxorubicin in AC16 cardiomyocytes, Mol. Cell. Toxicol. (2019). https://doi.org/10.1007/s13273-019-0044-6
I.A. González, Experiencia del paciente afectado por COVID-19 persistente acerca de la utilidad y características de las escalas de valoración clínica de los síntomas derivados de su enfermedad, Med. Gen. y Fam. 9 (2020) 121-125. https://doi.org/0.24038/mgyf.2021.018.
C.R. Rogers, Client-centered/person-centered approach to therapy, Vopr. Psikhol. (2001).
M. Méndez, Carl Rogers y Martin Buber: las actitudes del terapeuta Centrado en la Persona y la relación " Yo-Tú " en psicoterapia, Apunt. Psicol. 32 (2014) 171-180.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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5832
Identifier Type: -
Identifier Source: org_study_id
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