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Clinical Trial
. 2024 Aug 7;68(8):e0057324.
doi: 10.1128/aac.00573-24. Epub 2024 Jul 17.

H2 inhalation therapy in patients with moderate COVID-19 (H2COVID): a prospective ascending-dose phase I clinical trial

C Salomez-Ihl  1   2 , J Giai  3 , M Barbado  3 , A Paris  3 , S Touati  4 , J P Alcaraz  1 , S Tanguy  1 , C Leroy  3 , A Lehmann  2 , B Degano  5 , M Gavard  6 , P Bedouch  1   2 , P Pavese  4 , A Moreau-Gaudry  1   3 , M Roustit  3 , F Boucher  1 , P Cinquin  1   3 , J P Brion  4
Affiliations
Clinical Trial

H2 inhalation therapy in patients with moderate COVID-19 (H2COVID): a prospective ascending-dose phase I clinical trial

C Salomez-Ihl et al. Antimicrob Agents Chemother. .

Abstract

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.

Keywords: COVID-19; administration, inhalation; molecular hydrogen.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Fig 1
Fig 1
Design of the Single Ascending Dose study conducted in patients, with three doses (target durations) tested (D1–D3). D, duration; EDLT, exposure duration-limiting toxicity; MTD, maximum tolerated duration.
Fig 2
Fig 2
Overview of hydrogen inhalation in COVID-19 patients.
See this image and copyright information in PMC

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