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Authors
Clavo, Bernardino
Cánovas-Molina, Angeles
Cazorla-Rivero, Sara
Martínez-Sánchez, Gregorio
Galván, Saray
Benítez, Gretel
Federico, Mario
Fabelo, Himar
González-Martín, Jesús M.
García-Bello, Miguel A.
Lago-Moreno, Elba
Antonilli, Carla
Ramchandani, Avinash
Díaz-Garrido, Juan A.
Navarro, Minerva
Martín-Alfaro, Ruth
Hernández-López, Haidé
Callico, Gustavo M.
Rodríguez-Esparragón, Francisco
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Funding
Funding for this research was provided by:
Instituto de Salud Carlos III (PI23/01324)
Fundación Canaria Instituto de Investigación Sanitaria de Canarias (PIFIISC24/37)
Cabildo de Gran Canaria (CIGC’23-24)
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Article History
Received: 2 October 2025
Accepted: 26 November 2025
First Online: 22 January 2026
Declarations
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: This study protocol was approved by (i) the Ethics Committee of Las Palmas (Spain) on July 25, 2024 (reference number 2023-210-1) and (ii) the Spanish Medicines Agency (AEMPS) and European Medicines Agency (EMA) on November 19, 2024 (EU CT ID 2024-517196-20-00). It was registered in i) the Spanish Clinical Studies Registry (REEC) (ID: 2024-517196-20-00, Protocol Code: OzoParQT) and Clinicaltrials.gov (ID: NCT06706544) on January 22, 2025.The trial will be conducted in accordance with this protocol, the Good Clinical Practice (GCP) guidelines of the AEMPS, and the current EU/Spanish legislation on biomedical research. The trial will also be conducted in accordance with the principles outlined in the Declaration of Helsinki (Fortaleza, Brazil, 2013). Written informed consent will be obtained from all participants prior to their enrolment in the study.
: Not applicable. This manuscript does not contain any individual person’s data, images, or videos.
: Several approved O3T devices will be used interchangeably in this study. One of them (Ozonosan Alpha-plus ® ) was provided by Hänsler Medical GmbH, Iffezheim, Germany). Three other devices (Ozonobaric-P, SEDECAL, Madrid, Spain) were supported by a grant (COV20/00702) from the Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation, Madrid, Spain). In 2023, B.C. received financial support for a European grant application from Hänsler Medical GmbH (Iffezheim, Germany).The authors declare that the research will be conducted without any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that the funders had no role in the design of the study, in the collection, analysis, or interpretation of data, nor in the writing of this protocol, nor in the decision to publish the results, nor in the final manuscript. The authors declare no other potential conflict of interest than those described above.
