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 (HYDRO COVID)
SARS-CoV-2, Covid19, AMBULATORY CARE
About this trial
This is an interventional prevention trial for SARS-CoV-2 focused on measuring MOLECULAR HYDROGEN, anti-inflammatory role
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Timc-Imag (Umr5525 Uga-Cnrs)
- Casablanca center
- Public Health Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
TREATMENT GROUP
PLACEBO GROUP
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).
Water saturated with magnesium at the rate of 2 times 250 mL / day for 21 days. 80 mg of Mg, but in ionic form.