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

Status

Completed

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

      • Grenoble, France
        • CHU de Grenoble Alpes

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:

  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

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
  • 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
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.

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

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.

Clinical Trials on Covid-19

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