Status:
UNKNOWN
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
Lead Sponsor:
AGIR à Dom
Collaborating Sponsors:
Laboratoire TIMC-IMAG
DrinkHRW, British Columbia, Canada
Conditions:
SARS-CoV-2
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
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 suppo...
Detailed Description
CURRENT STATE OF KNOWLEDGE ON PATHOLOGY : SARS-CoV-2 is the causative agent of a new infectious respiratory disease called Covid-19 (for CoronaVirus Disease 2019) which is characterized primarily by ...
Eligibility Criteria
Inclusion
- 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
- History of pulmonary embolism and / or proximal deep vein thrombosis
- Asthma under inhaled corticosteroid therapy
- Paired sleep apnea syndrome
- Peripheral arterial disease of the lower limbs stage II and above
- Another risk factor presented, according to the list defined by the French High Council of Public Health
- OR Presence of at least 3 comorbidities, according to the Rapid Responses to COVID-19 from the French High Council of Public Health.
- Patient with nasopharyngeal swab (antigenic test, RT-PCR, or other HAS-validated swabs to come) :
- In case of positive test (antigenic test, RT-PCR, Other), patient with at least 1 symptom at the time of testing:
- In case of negative antigenic or other test or ongoing or uninterpretable RT-PCR test, the patient must present at least 3 of the 11 symptoms of COVID-19 dating back no more than 4 days as defined below and notion of contact (with a certain or probable COVID+ patient) dating back less than 10 days:
- Fever \> 37,5°C since 3 days Cough Sore throat/cold Headache Anosmia, dysgeusia Myalgias, arthralgias, bone pain Respiratory difficulties (feeling of dyspnea at rest) Chest pain (sternal) Digestive complaints (diarrhea, nausea, vomiting) Tachycardia (palpitation) Conjunctivitis (red eyes)
- No seriousness signs during the consultation and for at least 72 hours.
- Patient able to understand the procedure and follow it and have tools for a video-consultation.
- Affiliation to the social security system.
- Voluntary to participate to the study, informed consent form signed after appropriate information
Exclusion
- 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.
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04716985
Start Date
January 22 2021
End Date
May 22 2023
Last Update
April 5 2022
Active Locations (3)
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1
Timc-Imag (Umr5525 Uga-Cnrs)
Grenoble, France, 38000
2
Casablanca center
Casablanca, Morocco
3
Public Health Center
Kamenitz, Serbia