Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633980
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2020-11-16
Brief Title:
Hydrogen Therapy in Patients With Moderate Covid-19
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Hydrogen Inhalation Therapy in Patients With Moderate Covid-19 Phase-1 Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H2Covid
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None