tetano
Editor, Senior Moderator
J Clin Med
. 2024 Jul 24;13(15):4308.
doi: 10.3390/jcm13154308. Molecular Hydrogen for Outpatients with COVID-19 (Hydro-COVID): A Phase 3 Randomised, Triple-Blinded, Pragmatic, Placebo-Controlled, Multicentre Trial
Yoann Gaboreau[SUP] 1 [/SUP], Aleksandra Milovančev[SUP] 2 [/SUP], Carole Rolland[SUP] 1 [/SUP], Claire Eychenne[SUP] 1 [/SUP], Jean-Pierre Alcaraz[SUP] 1 [/SUP], Cordelia Ihl[SUP] 1 3 [/SUP], Roseline Mazet[SUP] 3 [/SUP], François Boucher[SUP] 1 [/SUP], Celine Vermorel[SUP] 1 [/SUP], Sergej M Ostojic[SUP] 4 [/SUP], Jean-Christian Borel[SUP] 5 [/SUP], Philippe Cinquin[SUP] 1 6 [/SUP], Jean-Luc Bosson[SUP] 1 6 [/SUP]
Affiliations
Background. Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H[SUB]2[/SUB]) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods: We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results: A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H[SUB]2[/SUB] group, 46.1% in the H[SUB]2[/SUB] group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H[SUB]2[/SUB] group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions: HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.
Keywords: COVID-19; molecular hydrogen; nutrient; outcome assessment; primary health care.
. 2024 Jul 24;13(15):4308.
doi: 10.3390/jcm13154308. Molecular Hydrogen for Outpatients with COVID-19 (Hydro-COVID): A Phase 3 Randomised, Triple-Blinded, Pragmatic, Placebo-Controlled, Multicentre Trial
Yoann Gaboreau[SUP] 1 [/SUP], Aleksandra Milovančev[SUP] 2 [/SUP], Carole Rolland[SUP] 1 [/SUP], Claire Eychenne[SUP] 1 [/SUP], Jean-Pierre Alcaraz[SUP] 1 [/SUP], Cordelia Ihl[SUP] 1 3 [/SUP], Roseline Mazet[SUP] 3 [/SUP], François Boucher[SUP] 1 [/SUP], Celine Vermorel[SUP] 1 [/SUP], Sergej M Ostojic[SUP] 4 [/SUP], Jean-Christian Borel[SUP] 5 [/SUP], Philippe Cinquin[SUP] 1 6 [/SUP], Jean-Luc Bosson[SUP] 1 6 [/SUP]
Affiliations
- PMID: 39124575
- PMCID: PMC11313273
- DOI: 10.3390/jcm13154308
Background. Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H[SUB]2[/SUB]) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods: We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results: A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H[SUB]2[/SUB] group, 46.1% in the H[SUB]2[/SUB] group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H[SUB]2[/SUB] group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions: HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.
Keywords: COVID-19; molecular hydrogen; nutrient; outcome assessment; primary health care.