Covid-19Phase 1H2CovidNCT04633980
Hydrogen Therapy in Patients With Moderate Covid-19
A Phase 1 study testing Mixture 3,6% H2 in N2 (96.4%) in people with Covid-19, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Mixture 3,6% H2 in N2 (96.4%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 23 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Covid-19
- Being tested
- Mixture 3,6% H2 in N2 (96.4%)
- Keywords
- SARS-CoV-2, H2 therapy, ARDS, Inflammation, Oxidative stress
- Medical subject headings
- COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture 3,6% H2 in N2 (96.4%)Drug
Route of administration: intra-nasal Debit 1L/min, 24h/24h (3 hours withdrawal tolerated) duration of treatment: 24 hours, 3 days and 6 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Mixture 3,6% H2 in N2 (96.4%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 days after the end of H2 therapy
Secondary outcomes (1)
biomarkers of inflammation and oxidative stress.
Serum levels of IL6, IL10, nitrated albumin, and alarmines
Measured: before and 3 days after the end of H2 therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Dec 2020
- Primary completion30 Jun 2022
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Paul Brion, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633980
- Sponsor's protocol ID
- 38RC20.277
- Acronym
- H2Covid
- Status last verified
- May 2023
- First submitted
- 16 Nov 2020
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salomez-Ihl C, Giai J, Barbado M, Paris A, Touati S, Alcaraz JP, Tanguy S, Leroy C, Lehmann A, Degano B, Gavard M, Bedouch P, Pavese P, Moreau-Gaudry A, Roustit M, Boucher F, Cinquin P, Brion JP. H2 inhalation therapy in patients with moderate COVID-19 (H2COVID): a prospective ascending-dose phase I clinical trial. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0057324. doi: 10.1128/aac.00573-24. Epub 2024 Jul 17.
PubMed 39016593
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen Inhalation Therapy in Patients With Moderate Covid-19: Phase-1 Clinical Trial
- ClinicalTrials.gov ID
- NCT04633980
- Acronym / sponsor ID
- H2Covid / 38RC20.277
- Conditions
- Covid-19
- Keywords
- SARS-CoV-2, H2 therapy, ARDS, Inflammation, Oxidative stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Mixture 3,6% H2 in N2 (96.4%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Experimental group |
Primary outcome
adverse events
Time frame: Up to 3 days after the end of H2 therapy
* 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
1 secondary outcome
biomarkers of inflammation and oxidative stress.
Time frame: before and 3 days after the end of H2 therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 39016593Salomez-Ihl C, Giai J, Barbado M, Paris A, Touati S, Alcaraz JP, Tanguy S, Leroy C, Lehmann A, Degano B, Gavard M, Bedouch P, Pavese P, Moreau-Gaudry A, Roustit M, Boucher F, Cinquin P, Brion JP. H2 inhalation therapy in patients with moderate COVID-19 (H2COVID): a prospective ascending-dose phase I clinical trial. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0057324. doi: 10.1128/aac.00573-24. Epub 2024 Jul 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Paul Brion, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mixture 3,6% H2 in N2 (96.4%) in people with Covid-19, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: Up to 3 days after the end of H2 therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.