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Hydrogen Therapy in Patients With Moderate Covid-19 (H2Covid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04633980
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Mixture 3,6% H2 in N2 (96.4%) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydrogen Inhalation Therapy in Patients With Moderate Covid-19: Phase-1 Clinical Trial
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : November 19, 2022
Estimated Study Completion Date : April 19, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient ≥18 years old
  2. Suspicion of SARS CoV-2 infection based on clinical signs AND (positive PCR OR positive serology OR suggestive abnormalities on lung-imaging modalities)
  3. 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%
  4. Patient understanding and agreeing to comply with the planned study procedures
  5. Patient affiliated with social security or beneficiary of such protection
  6. Patient (or his legal representative) who has given his informed consent in writing before the start of any study procedure.

Exclusion Criteria:

  1. Pregnant or parturient women
  2. Ratio of spontaneous blood ALT/AST> 5 times the normal upper limit.
  3. Stage 4 of severe chronic kidney disease or requiring dialysis (i.e. eGFR <30)
  4. Early transfer to another hospital within 72 hours.
  5. Contraindication to any study drug, including a known allergy
  6. Uncontrolled and clinically significant heart disease, such as arrhythmias, angina pectoris or uncompensated congestive heart failure
  7. Patients treated in ambulatory care (i.e. not hospitalized)
  8. Females of childbearing potential, defined as a premenopausal female capable of becoming pregnant, and not using an highly effective form of birth control.
  9. Participant involved in another interventional clinical study
  10. Person deprived of liberty by judicial order
  11. Person under guardianship or curatorship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633980


Contacts
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Contact: BOUCHER François, PhD 0033476637117 Francois.Boucher@univ-grenoble-alpes.fr
Contact: Saber TOUATI, PhD 0033476765805 stouati1@chu-grenoble.fr

Locations
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France
CHU de Grenoble Alpes Recruiting
Grenoble, France
Contact: Jean Paul Brion, MD       JPBrion@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Jean Paul Brion, MD University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04633980    
Other Study ID Numbers: 38RC20.277
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
SARS-CoV-2
H2 therapy
ARDS
Inflammation
Oxidative stress
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases