EuroQol-5D-3L in Long Covid patients After Supplementation with EchA Marine, a Sea Urchin Eggs Extract: a double-blinded, multicentrical study.

Patients with Long COVID experience a significant decrease in their quality of life and the lack of effective treatment represents an unmet need in medical care and patient health. One proposed strategy for treating Long COVID is to increase the ability of the body to restore immune balance by controlling inflammation with anti-inflammatory substances. For this reason, the aim of this double-blind study was to evaluate the supplementation of patients with EchA Marine, a dietary supplement based on sea urchin eggs rich in Echinochrome A. This compound has demonstrated anti-inflammatory and antioxidant properties by activating the metabolism of glutathione and improving mitochondrial mass and performance. The EuroQol 5-Dimension (EQ-5D) is a standardized questionnaire assessing five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used as an instrument to measure health-related quality of life in clinical and economic studies. In this multicenter, double-blind, intervention study, we have demonstrated that the dietary supplement EchA Marine can significantly enhance the quality of life of these patients, particularly in pain and discomfort; notably improving their quality of life and ability in daily activities. EchA Marine is an effective treatment option for Long COVID patients and with further research its efficacy could be further strengthened. Clinical trial registration number: [NCT05531019][1]. First posted September 7th, 2022. ### Competing Interest Statement TR is co-founder of Erisea S.A. that produced the Dietary Supplement for the Clinical Trial. VC is employee of EriSea S.A. The rest of the authors declare no potential conflict of interest. ### Clinical Trial NCT05531019 ### Funding Statement This work was founded by the grant PICTO Sequelas COVID-19 00009 from The National Agency for the Promotion of Research, Technological Development and Innovation. EchA Marine supplements for the complete clinical trial were donated by Erisea S.A. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study has been approved by the Ethics Committees of the Hospital Donacion Francisco Santojanni (CR 5832), Hospital General de Agudos Jose Maria Ramos Mejia (CR5196), and Hospital de Infecciosas Francisco Javier Muniz (CR 5240). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets generated and/or analysed during the current study are available in the CONICET Institutional repository. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05531019&atom=%2Fmedrxiv%2Fearly%2F2023%2F06%2F05%2F2023.05.31.23290798.atom