Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of COVID-19 Positive Patients (NCT05539664) | Clinical Trial Compass
UnknownNot Applicable
Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of COVID-19 Positive Patients
China188 participantsStarted 2022-05-16
Plain-language summary
This is a prospective, multicenter, randomized, controlled, superiority clinical trial. It is expected that the test group would have better effectiveness than the control group in the primary evaluation indicator (time to negative viral nucleic acid detection from the start of study treatment). The test group will use the investigational medical device Hydrogen-Oxygen Generator with Nebulizer (Shanghai Asclepius Meditec Co., Ltd.) + basic treatment (the investigator provides corresponding symptomatic support treatment based on the condition of the patients), and the control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment, to evaluate the effectiveness and safety of the investigational medical device Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects aged between 18 and 80 years old (inclusive).
* Diagnosed as general type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 9).
* Subjects who are willing to participate and provided written informed consent form.
Exclusion Criteria:
* Diagnosed as mild, severe, critical or asymptomatic type of COVID-19.
* Subjects in the treatment or active stage of malignant tumor.
* Subjects who are intolerable to inhalation treatment.
* Subjects with mental disorders or cognitive impairment who are unable to provide consent.
* Subjects with any immunodeficiency requiring chronic treatment with any corticosteroid or other immunosuppressants.
* Complicate serious primary diseases such as heart, liver, kidney, and hematopoietic diseases; acute exacerbation phase of chronic obstructive pulmonary disease, or acute attack of bronchial asthma.
* Subjects who are using any non-expectorant antioxidant drug, including large doses of vitamin C and vitamin E.
* Subjects who are participating any other clinical study of any investigational drug or medical device.
* Pregnant or lactating women.
* Any other condition judged as inappropriate to participate in this study by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to negative viral nucleic acid detection from the start of the study treatment.
Timeframe: through study completion, The average time from enrollment to two consecutive negative nucleic acid tests of respiratory specimens (sampling time interval of at least 24 hours) was approximately 7 days