Hydrogen Therapy in Patients With Moderate Covid-19 (H2Covid)
Primary Purpose
Covid-19
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Mixture 3,6% H2 in N2 (96.4%)
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19 focused on measuring SARS-CoV-2, H2 therapy, ARDS, Inflammation, Oxidative stress
Eligibility Criteria
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
Sites / Locations
- CHU de Grenoble Alpes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
Outcomes
Primary Outcome Measures
adverse events
observed grade >=4 toxicity from the "Respiratory, thoracic and mediastinal disorders" section of CTCAE v5.0
OR observed grade >=3 toxicity from other sections of CTCAE v5.0
OR any relevant deterioration in the health of the subject
AND at least possibly related with H2
Secondary Outcome Measures
biomarkers of inflammation and oxidative stress.
Serum levels of IL6, IL10, nitrated albumin, and alarmines
Full Information
NCT ID
NCT04633980
First Posted
November 16, 2020
Last Updated
May 25, 2023
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04633980
Brief Title
Hydrogen Therapy in Patients With Moderate Covid-19
Acronym
H2Covid
Official Title
Hydrogen Inhalation Therapy in Patients With Moderate Covid-19: Phase-1 Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
May 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
SARS-CoV-2, H2 therapy, ARDS, Inflammation, Oxidative stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mixture 3,6% H2 in N2 (96.4%)
Intervention Description
Route of administration: intra-nasal Debit 1L/min, 24h/24h (3 hours withdrawal tolerated) duration of treatment: 24 hours, 3 days and 6 days
Primary Outcome Measure Information:
Title
adverse events
Description
observed grade >=4 toxicity from the "Respiratory, thoracic and mediastinal disorders" section of CTCAE v5.0
OR observed grade >=3 toxicity from other sections of CTCAE v5.0
OR any relevant deterioration in the health of the subject
AND at least possibly related with H2
Time Frame
Up to 3 days after the end of H2 therapy
Secondary Outcome Measure Information:
Title
biomarkers of inflammation and oxidative stress.
Description
Serum levels of IL6, IL10, nitrated albumin, and alarmines
Time Frame
before and 3 days after the end of H2 therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Paul Brion, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Grenoble Alpes
City
Grenoble
Country
France
12. IPD Sharing Statement
Learn more about this trial
Hydrogen Therapy in Patients With Moderate Covid-19
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