NCT05504460

Hydrogen-Oxygen Generator With Nebulizer for Rehabilitation Treatment of COVID-19

A Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Hydrogen-Oxygen Generator With Nebulizer for Rehabilitation Treatment of Dysfunctions in Discharged Patients Who Are Previously Hospitalized Due to COVID-19

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A total of 216 eligible subjects will be randomly assigned to the test group and the control group in a 1:1 ratio to receive corresponding treatment (treatment in both groups will last for 12 months), and the subjects will then be followed up for 12 months from the start of treatment after enrollment. All subjects enrolled in this study will receive seven visits, including the screening visit (within 14 days before the enrollment), randomization and treatment visit (Day 0), visits at 1 month after the start of the treatment (± 7 days), 2 months after the start of the treatment (± 7 days), 3 months (± 14 days) after the start of the treatment, 6 months (± 14 days) after the start of the treatment, and 12 months (± 30 days) after the start of the treatment. The following indicators of the two groups will be collected and analyzed in this study: the primary effectiveness evaluation indicator: changes in Borg score and PSQI index at 3 months after the start of the treatment; secondary effectiveness evaluation indicators: 1) Pulmonary function assessment indicators (forced expiratory volume in one second \[FEV1\], ratio of forced expiratory volume in one second to forced vital capacity \[FEV1/FVC\], 25/50/75% maximal mid expiratory flow \[MMEF 25/50/75\], and fractional exhaled nitric oxide \[FeNO\]); 2) Lung imaging changes; 3) Neurological and psychological function assessment indicators (Mini-Mental State Examination Scale \[MMSE\] score, Generalized Anxiety Disorder Scale \[GAD-7\] score, Depression Screening Scale \[PHQ-9\] score, Post-Traumatic Stress Disorder Checklist \[PCL-C\]); 4) Inflammatory indicators (neutrophil-to-lymphocyte ratio \[NLR\], C-reactive protein \[CRP\], interleukin-6 \[IL-6\]); 5) Evaluation of device usability, and the safety evaluation indicators: incidence of AEs and SAEs, and incidence of device deficiencies. When all enrolled subjects have completed the follow up at 3 months after the start of the treatment, an analysis will be performed for application to the National Medical Products Administration (NMPA) for registration of the investigational medical device, while the 6- and 12-month follow up will be continued spontaneously.

Conditions

• COVID-19
• AMS-H-03
• Hydrogen-oxygen Gas

Interventions

Type	Name	Description
DEVICE	Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03	Treatments in the test group will lasts for 12 months, and symptomatic treatment will be provided based on the actual symptoms of the subjects. Subjects in the test group will be required to receive inhalation for at least 4 days every 7 days with at least 3780L inhaled every 7 days (It is recommended to inhale at least 540L per day; If the flow rate is 3L/min, it is recommended that the cumulative inhalation time should be at least 3 hours per day. If the flow rate is 1.5L/min, it is recommended that the cumulative inhalation time should be at least 6 hours per day).
OTHER	basic treatment	supportive treatment determined by the investigator based on the condition of the patients

Timeline

• Start date: 2022-08-12
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-08-17
• Last updated: 2022-08-17

Locations

1 site across 1 country: China