Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019… (NCT05770206) | Clinical Trial Compass
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Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
China218 participantsStarted 2023-04-01
Plain-language summary
This is a multi-center, randomized, parallel controlled, double-blinded clinical trial to evaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients. The test group is expected to be superior to the control group in the primary endpoint (percentage of subjects achieving clinical recovery at Day 7 of study treatment). Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); and subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female subjects aged between 18 and 75 years old (inclusive).
✓. Diagnosed with mild, moderate or severe type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 10).
✓. Positive result for COVID-19 nucleic acid test or rapid antigen detection at screening visit;
✓. Presenting with at least one respiratory symptom (e.g. dyspnoea, shortness of breath) at hospital admission.
✓. Be willing to participate in this trial and provide written informed consent form.
Exclusion criteria
✕. Subjects with critical or asymptomatic type of COVID-19;
✕. Subjects with any known malignant tumor or life expectancy less than half a year.
✕. Subjects who are intolerable to inhalation treatment.
✕. Subjects with mental disorders or cognitive impairment who are unable to provide consent.
What they're measuring
1
the percentage of subjects with clinical recovery on Day 7 of study treatment.
✕. Subjects with any immunodeficiency requiring chronic treatment with any corticosteroid or other immunosuppressants.
✕. Complicate with any serious cardiac, hepatic or renal disease (as indicated by aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] ≥ 2 × upper limit of normal \[ULN\], or creatinine ≥ 176.8mmol/L, or New York Heart Association (NYHA) Classification for heart failure of Class IV) or any serious primary systematic disease.
✕. Subjects who are going to use any non-expectorant antioxidant drug, including large doses of vitamin C and vitamin E during the study period.
✕. Subjects who are participating in any other clinical study on any investigational drug or medical device.