- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633980
Hydrogen Therapy in Patients With Moderate Covid-19 (H2Covid)
May 25, 2023 updated by: University Hospital, Grenoble
Hydrogen Inhalation Therapy in Patients With Moderate Covid-19: Phase-1 Clinical Trial
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Saber TOUATI, PhD
- Phone Number: 0033476765805
- Email: stouati1@chu-grenoble.fr
Study Contact Backup
- Name: BOUCHER François, PhD
- Phone Number: 0033476637117
- Email: Francois.Boucher@univ-grenoble-alpes.fr
Study Locations
-
-
-
Grenoble, France
- CHU de Grenoble Alpes
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient ≥18 years old
- Suspicion of SARS CoV-2 infection based on clinical signs AND (positive PCR OR positive serology OR suggestive abnormalities on lung-imaging modalities)
- Hospitalized patients with SpO2 ≤94% on room air requiring normobaric oxygen therapy with a nasal flow of O2 ≤ 6L / min to reach at least SaO2 ≥ 95%
- Patient understanding and agreeing to comply with the planned study procedures
- Patient affiliated with social security or beneficiary of such protection
- Patient (or his legal representative) who has given his informed consent in writing before the start of any study procedure.
Exclusion Criteria:
- Pregnant or parturient women
- Ratio of spontaneous blood ALT/AST> 5 times the normal upper limit.
- Stage 4 of severe chronic kidney disease or requiring dialysis (i.e. eGFR <30)
- Early transfer to another hospital within 72 hours.
- Contraindication to any study drug, including a known allergy
- Uncontrolled and clinically significant heart disease, such as arrhythmias, angina pectoris or uncompensated congestive heart failure
- Patients treated in ambulatory care (i.e. not hospitalized)
- Females of childbearing potential, defined as a premenopausal female capable of becoming pregnant, and not using an highly effective form of birth control.
- Participant involved in another interventional clinical study
- Person deprived of liberty by judicial order
- Person under guardianship or curatorship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
|
Route of administration: intra-nasal Debit 1L/min, 24h/24h (3 hours withdrawal tolerated) duration of treatment: 24 hours, 3 days and 6 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events
Time Frame: Up to 3 days after the end of H2 therapy
|
|
Up to 3 days after the end of H2 therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biomarkers of inflammation and oxidative stress.
Time Frame: before and 3 days after the end of H2 therapy
|
Serum levels of IL6, IL10, nitrated albumin, and alarmines
|
before and 3 days after the end of H2 therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean Paul Brion, MD, University Hospital, Grenoble
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
May 23, 2023
Study Registration Dates
First Submitted
November 16, 2020
First Submitted That Met QC Criteria
November 17, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
May 26, 2023
Last Update Submitted That Met QC Criteria
May 25, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC20.277
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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