COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04716985

Yoann Gaboreau

Not reported

2021-01-20

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

- 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.

2

AGIR à Dom

18

100

France;Morocco;Serbia

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

700

Change in the incidence rate of the onset of clinical worsening

None

Not reported

[{"arm_notes": "", "treatment_id": 811, "treatment_name": "Molecular hydrogen", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2225, "treatment_name": "Magnesium sulfate+molecular hydrogen", "treatment_type": "Vitamins and dietary supplements+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]