Evaluation of the Daily Intake of 0.5 L of Water Saturated With Molecular Hydrogen for 21 Days in COVID-19 Patients Treated in Ambulatory Care

NCT04716985 | Unknown

• 1 other identifier: 2020-A03137-32
• Study Type: interventional
• Target: 700
• Locations: 3 countries
• Sites: 3

Brief Summary

Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19. This hypothesis is supported by numerous preclinical and theoretical arguments, as well as by some Chinese clinical studies (the Chinese guidelines for the management of Covid-19 recommend the inhalation of hydrogen), a recommendation whose interest has just been confirmed by a publication describing the very positive results of a clinical study in China. Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19. The ingestion of water saturated with molecular hydrogen has been the subject of several clinical studies in other indications than Covid-19, and no side effects of this ingestion have been reported. A recent publication recommends initiating clinical trials using a hydrogen fortified beverage.

Conditions

SARS-CoV-2; Covid19; AMBULATORY CARE

Keywords

MOLECULAR HYDROGEN; anti-inflammatory role

Outcome Measures

Primary Outcomes (1)

• Change in the incidence rate of the onset of clinical worsening

  Demonstrate that the daily ingestion of 250 mL twice a day, i.e. 0.5 L of water saturated with molecular hydrogen for 21 days compared to water not enriched in hydrogen, decreases the incidence rate of the appearance of clinical worsening in patients within 12 to 14 days following a COVID-19 + diagnosis with outpatient care. The primary endpoint is a composite endpoint combining worsening of dyspnea, fatigue, putting on 02, hospitalizations, death occurring within 12 to 14 days of inclusion in the study. The worsening of dyspnea, fatigue being defined as an increase of 25% via Chalder scale for fatigue, MMRC scale for dyspnea. Chalder scale with 11 items (mental 7 questions yes/no and physical symptoms 4 questions yes/no) MMRC scale with 4 stades (stade 0 "no dyspnea" to 4 "strong dyspnea")

  12 to 14 days

Secondary Outcomes (13)

• Assessment of tolerance

  30 days

• Assessment of compliance

  21 days

• Assessment of medium-long term dyspnea symptoms

  30 Days, 3 months, 12 months

• Assessment of medium-long term fatigue symptoms

  30 Days, 3 months, 12 months

• Assessment of oximetry symptoms

  30 Days

Study Arms (2)

TREATMENT GROUP

ACTIVE COMPARATOR

Water saturated with molecular hydrogen at the rate of 2 times 250 mL / day for 21 days. 80 mg of Mg metal, and safe excipients (dextrose, malic acid, L-tartaric acid, adipic acid).

Dietary Supplement: MOLECULAR HYDROGEN

PLACEBO GROUP

PLACEBO COMPARATOR

Water saturated with magnesium at the rate of 2 times 250 mL / day for 21 days. 80 mg of Mg, but in ionic form.

Dietary Supplement: PLACEBO MAGNESIUM

Interventions

MOLECULAR HYDROGEN DIETARY_SUPPLEMENT

Magnesium Tablet

TREATMENT GROUP

PLACEBO MAGNESIUM DIETARY_SUPPLEMENT

Magnesium carbonate tablet

PLACEBO GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 59 years old or over 60 years old.
• If patient 18 to 59 years old, presence of at least one risk factor :
• Hypertension under treatment (all stages)
• Obesity (BMI ≥30 kg / m2)
• Diabetes under treatment (all types)
• Stable ischemic heart disease (all stages)
• Atrial fibrillation
• Stable heart failure (all stages)
• History of stroke
• Stage 3 chronic renal failure (30 ≤ estimated GFR \<60 mL / min / 1.73 m²)
• COPD (all stages, including chronic respiratory failure under long-term oxygen therapy)
• Solid tumors or malignant hemopathies that are progressive or whose diagnosis is less than 5 years old
• Immunodeficiency:
• of therapeutic origin (solid organ transplantation or transplant of hematopoietic stem cells, anticancer chemotherapy, immunosuppressive treatment, corticosteroid therapy\> 15 mg / day equivalent to prednisone price for at least 2 months);
• or HIV infection and last known CD4 count \<200 / mm3

You may not qualify if:

• The absence of attending or referring physician
• Any sign of seriousness incompatible with home care.
• Severe chronic kidney failure or dialysis (i.e. DFGe \<30).
• drink cure Contraindication (500 ml/d for 21 days).
• Contraindication to any drug in the study, including a known allergy, especially magnesium.
• Uncontrolled and clinically significant heart disease, whether its origin (arrhythmias, angina, uncompensated congestive heart failure).
• Subject participating to an other clinical study interventional.
• Person deprived of liberty or under legal guardianship.
• No one in the same household who participated in this study.
• Patient refusing hospitalization.
• Persons subject to sections L1121-7 and L1121-8 of the CSP (minor, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure) or not able to communicate his consent verbally.

Sponsors & Collaborators

• AGIR à Dom: lead
• Laboratoire TIMC-IMAG: collaborator
• DrinkHRW, British Columbia, Canada: collaborator

Study Sites (3)

Timc-Imag (Umr5525 Uga-Cnrs)

Grenoble, 38000, France

Location

Casablanca center

Casablanca, Morocco

Location

Public Health Center

Kamenitz, Serbia

Location

Related Publications (23)

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• TY - JOUR AU - Russell, Grace AU - Veal, David AU - Rehman, Mubasher AU - Adukwu, Emmanuel AU - LeBaron, Tyler AU - Hancock, John PY - 2020/06/22 SP - T1 - An Overview of SARS-CoV-2 (COVID-19) Infection and the Importance of Molecular Hydrogen as an Adjunctive Therapy DO - 10.20455/ros.2020.829 JO - Reactive Oxygen Species ER -

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  BACKGROUND

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  BACKGROUND

Related Links

• High Council of Public Health. Opinion of 29 October 2020 on the updating of the list of risk factors for the severe form of COVID-19
• High Authority of Health. Rapid responses in the context of Covid-19 - Primary care of patients suspected of Covid-19. Paris, June 18, 2020. Updated in Nov 2020

MeSH Terms

Conditions

COVID-19

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Study Officials

• Yoann Gaboreau, Dr

  Laboratoire TIMC Equipe Themas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: They will be labeled study (randomization number to respect blind and legal notices labeling clinical research).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, multicentre comparative study.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: January 22, 2021
• Primary Completion: May 22, 2022
• Study Completion: May 22, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); FR (1); MO (1)