H 2 inhalation therapy in patients with moderate COVID-19 (H 2 COVID): a prospective ascending-dose phase I clinical trial.

Autor:	Salomez-Ihl C; Université Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, Grenoble, France.; Department of Pharmacy, Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France., Giai J; Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Centre for Clinical Investigation, Grenoble, France., Barbado M; Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Centre for Clinical Investigation, Grenoble, France., Paris A; Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Centre for Clinical Investigation, Grenoble, France., Touati S; Department of Infectious and Tropical Diseases, CHU Grenoble Alpes, Grenoble, France., Alcaraz JP; Université Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, Grenoble, France., Tanguy S; Université Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, Grenoble, France., Leroy C; Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Centre for Clinical Investigation, Grenoble, France., Lehmann A; Department of Pharmacy, Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France., Degano B; Department of Pneumology, CHU Grenoble Alpes, Grenoble, France., Gavard M; CHU Grenoble Alpes, Delegation for Clinical Research and Innovation, Grenoble, France., Bedouch P; Université Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, Grenoble, France.; Department of Pharmacy, Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France., Pavese P; Department of Infectious and Tropical Diseases, CHU Grenoble Alpes, Grenoble, France., Moreau-Gaudry A; Université Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, Grenoble, France.; Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Centre for Clinical Investigation, Grenoble, France., Roustit M; Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Centre for Clinical Investigation, Grenoble, France., Boucher F; Université Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, Grenoble, France., Cinquin P; Université Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, CHU Grenoble Alpes, TIMC, UMR5525, Grenoble, France.; Univ. Grenoble Alpes, Inserm, CHU Grenoble Alpes, Centre for Clinical Investigation, Grenoble, France., Brion JP; Department of Infectious and Tropical Diseases, CHU Grenoble Alpes, Grenoble, France.
Jazyk:	angličtina
Zdroj:	Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2024 Aug 07; Vol. 68 (8), pp. e0057324. Date of Electronic Publication: 2024 Jul 17.
DOI:	10.1128/aac.00573-24
Abstrakt:	The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has triggered a serious global health crisis, resulting in millions of reported deaths since its initial identification in China in November 2019. The global disparities in immunization access emphasize the urgent need for ongoing research into therapeutic interventions. This study focuses on the potential use of molecular dihydrogen (H2) inhalation as an adjunctive treatment for COVID-19. H2 therapy shows promise in inhibiting intracellular signaling pathways associated with inflammation, particularly when administered early in conjunction with nasal oxygen therapy. This phase I study, characterized by an open-label, prospective, monocentric, and single ascending-dose design, seeks to assess the safety and tolerability of the procedure in individuals with confirmed SARS-CoV-2 infection. Employing a 3 + 3 design, the study includes three exposure durations (target durations): 1 day (D1), 3 days (D2), and 6 days (D3). We concluded that the maximum tolerated duration is at least 3 days. Every patient showed clinical improvement and excellent tolerance to H2 therapy. To the best of our knowledge, this phase I clinical trial is the first to establish the safety of inhaling a mixture of H2 (3.6%) and N2 (96.4%) in hospitalized COVID-19 patients. The original device and method employed ensure the absence of explosion risk. The encouraging outcomes observed in the 12 patients included in the study justify further exploration through larger, controlled clinical trials. Clinical Trials: This study is registered with ClinicalTrials.gov as NCT04633980. Competing Interests: The authors declare no conflict of interest.
Databáze:	MEDLINE
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