Hydrogen-Oxygen Generator With Nebulizer for Rehabilitation Treatment of COVID-19 (NCT05504460) | Clinical Trial Compass
UnknownNot Applicable
Hydrogen-Oxygen Generator With Nebulizer for Rehabilitation Treatment of COVID-19
China216 participantsStarted 2022-08-12
Plain-language summary
This is a prospective, multicenter, randomized, controlled, superiority clinical trial, with the test group expected to be superior to the control group in the primary evaluation endpoints (changes in Borg score and PSQI index at 3 months after the start of the treatment). The test group will use the investigational device Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd.) + basic treatment (supportive treatment determined by the investigator based on the condition of the patients), and the control group will use basic treatment only, to evaluate of effectiveness and safety of the investigational device Hydrogen-Oxygen Generator with Nebulizer for rehabilitation treatment of dysfunctions in discharged patients who are previously hospitalized due to 2019 novel coronavirus pneumonia (COVID-19).
Who can participate
Age range
18 Years – 75 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 75 years old (inclusive);
* Subjects previously hospitalized due to COVID-19, who are recovered and discharged with negative results for COVID-19 and released from quarantine;
* Known symptoms of respiratory dysfunctions (such as dyspnea), and / or neurological/psychological dysfunction (such as sleep disorders, anxiety, and depression) and / or somatic dysfunction (such as fatigue);
* Borg dyspnea or fatigue score before study treatment ≥ 1 (please refer to Appendix 2: Borg Scale for specific information), and PSQI score ≥ 2 (please refer to Appendix 3: PSQI Scale for specific information);
* Subjects who are willing to participate and provided written informed consent form.
Exclusion Criteria:
* Subjects with known malignant tumor;
* Subjects with known moderate or severe pulmonary infection;
* Subjects with mucosa injury in upper respiratory tract, for whom no inhalation treatment can be provided;
* Subjects who are intolerable to inhalation treatment;
* Subjects with moderate or severe disabilities;
* Subjects with mental disorders or cognitive impairment who are unable to provide consent;
* Subjects with neurological disease accompanied with sleep disorders for which medical intervention is provided before the diagnosis of COVID-19.
* Subjects with any immunodeficiency (for example, subjects requiring chronic treatment with any corticosteroid or other immunosuppressants) judged by the investigator;
* A…
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
Changes in Borg score index from baseline at 3 months after the start of the study treatment.
Timeframe: Changes in Borg score assessed after the 6-minute walk test at 3 months (±7 days)
2
Changes in PSQI index from baseline at 3 months after the start of the study treatment.
Timeframe: Changes in PSQI index at 3 months (±7 days) after the start of the treatment of the subjects in the test group or the control group compared with that before treatment.