NCT04633980

Hydrogen Therapy in Patients With Moderate Covid-19

Hydrogen Inhalation Therapy in Patients With Moderate Covid-19: Phase-1 Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SARS-CoV-2 is the agent responsible for a new infectious respiratory disease called Covid-19 (for CoronaVirus Disease 2019) which is mainly characterized by potentially severe and fatal lung damage. The severity of the clinical signs associated with this pathology requires the admission to hospital of approximately 20% of patients, 5%-10% of whom will be admitted to intensive care. The most severe cases of this pathology begin with dyspnea which worsens rapidly around the 7th-10th day of the disease into an acute respiratory distress syndrome (ARDS) which requires the patient to be put under mechanical ventilation in the intensive care unit and is responsible for the majority of deaths. Certain biological parameters suggest a massive and brutal release of cytokines (interleukins IL-6, IL-8 and IL-10 mainly) secondary to a syndrome of macrophagic activation mainly in the pulmonary level. Several therapeutic trials aimed at reducing or controlling this immune storm are in progress (anti IL-6 antibodies, anti r IL6 Ab, corticosteroids). Molecular hydrogen acts on the final path of this complex inflammatory cascade by inhibiting the cellular action of reactive oxygen species. Its early use combined with nasal oxygen therapy could prevent this worsening of the respiratory system, so could be likely to limit the risk of overflow of intensive care services during the pandemic and save lives. The aim of this study is to evaluate the safety and the Dose Limiting Toxicity (DLT) of hydrogen therapy delivered by a nasal cannula in addition to conventional oxygen therapy in patients with moderate Covid-19

Conditions

• Covid-19

Interventions

Type	Name	Description
DRUG	Mixture 3,6% H2 in N2 (96.4%)	Route of administration: intra-nasal Debit 1L/min, 24h/24h (3 hours withdrawal tolerated) duration of treatment: 24 hours, 3 days and 6 days

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-06-30
• Completion: 2023-05-23
• First posted: 2020-11-18
• Last updated: 2023-05-26

Locations

1 site across 1 country: France