AzTrials
AzTrials

COVID-19NCT05504460

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

A study testing Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and basic treatment in people with COVID-19 and AMS-H-03, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
COVID-19, AMS-H-03, Hydrogen-oxygen Gas
What is being tested?
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and basic treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
12 Aug 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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;
  • Allergy to any component of the investigational product that have contact with human body;
  • Complicate severe cardiac, hepatic or renal insufficiency;
  • Expected life expectancy < 1 year;
  • Subjects who are participating in any other clinical study of any investigational drug or medical device;
  • Pregnant or lactating women, or women who plan to become pregnant within the following one year;
  • Any other condition judged as inappropriate to participate in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

Yuanlin Song, PhD contact

86-15021757762

ylsong@163.com

China1 site, 1 recruiting

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

    Yuanlin Song, PhD, 15021757762, ylsong@163.com

    Recruiting

Other trials in China

About this study

Official title: 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

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).

Read the 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.

Being tested
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, basic treatment
Keywords
COVID-19, Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, Hydrogen-oxygen Gas
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03Device

    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).

  • basic treatmentOther

    supportive treatment determined by the investigator based on the condition of the patients

Study groups in NCT05504460
Study groupRoleWhat they receive
test groupExperimentalThe 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)
Receives: Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03; Other: basic treatment
Control GroupActive comparatorthe control group will use basic treatment only
Receives: Other: basic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Borg score index from baseline at 3 months after the start of the study treatment.

    after the start of the treatment compared to Borg score assessed after the 6-minute walk test before treatment in the test or the control group.

    Measured: 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.

    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.

    Measured: 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.

Secondary outcomes (15)

  1. Pulmonary function evaluation: FEV1

    Pulmonary function evaluation: FEV1

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  2. Change in imaging evaluation

    It is defined as the change in lung imaging results evaluated by CT examination

    Measured: 3 months (±14 days), 6 months (±14 days, as needed), and 12 months (±30 days)

  3. Neurological and psychological function indicators including MMSE score

    Neurological and psychological function indicators including MMSE score

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  4. Inflammatory indicators, including NLR

    Inflammatory indicators, including NLR

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  5. Usability evaluation of the medical device

    It is defined as the results of the evaluation on usability of the investigational medical device conducted according to the following table

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  6. Pulmonary function evaluation: FEV1/FVC

    Pulmonary function evaluation: FEV1/FVC

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  7. Pulmonary function evaluation: MMEF 25

    Pulmonary function evaluation: MMEF 25

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  8. Pulmonary function evaluation: MMEF50

    Pulmonary function evaluation: MMEF 50

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  9. Pulmonary function evaluation: MMEF 75

    Pulmonary function evaluation: MMEF 75

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  10. Pulmonary function evaluation: FeNO

    Pulmonary function evaluation: FeNO

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  11. Neurological and psychological function indicators including GAD-7 score

    Neurological and psychological function indicators including GAD-7 score

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  12. Neurological and psychological function indicators including PHQ-9 score

    Neurological and psychological function indicators including PHQ-9 score

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  13. Neurological and psychological function indicators including PCL-C score

    Neurological and psychological function indicators including PCL-C score

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  14. Inflammatory indicators, including CRP

    Inflammatory indicators, including CRP

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

  15. Inflammatory indicators, including IL-6

    Inflammatory indicators, including IL-6

    Measured: 1 month (±7 days), 2 months (±7 days), 3 months (±14 days), 6 months (±14 days) and 12 months (±30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start12 Aug 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05504460
Sponsor's protocol ID
AMS-H-03-104
Status last verified
Aug 2022
First submitted
16 Aug 2022
Last updated
17 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sanyaolu A, Marinkovic A, Prakash S, Zhao A, Balendra V, Haider N, Jain I, Simic T, Okorie C. Post-acute Sequelae in COVID-19 Survivors: an Overview. SN Compr Clin Med. 2022;4(1):91. doi: 10.1007/s42399-022-01172-7. Epub 2022 Apr 6.

    PubMed 35411333

  • Huang L, Yao Q, Gu X, Wang Q, Ren L, Wang Y, Hu P, Guo L, Liu M, Xu J, Zhang X, Qu Y, Fan Y, Li X, Li C, Yu T, Xia J, Wei M, Chen L, Li Y, Xiao F, Liu D, Wang J, Wang X, Cao B. 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study. Lancet. 2021 Aug 28;398(10302):747-758. doi: 10.1016/S0140-6736(21)01755-4.

    PubMed 34454673

  • Blomberg B, Mohn KG, Brokstad KA, Zhou F, Linchausen DW, Hansen BA, Lartey S, Onyango TB, Kuwelker K, Saevik M, Bartsch H, Tondel C, Kittang BR; Bergen COVID-19 Research Group; Cox RJ, Langeland N. Long COVID in a prospective cohort of home-isolated patients. Nat Med. 2021 Sep;27(9):1607-1613. doi: 10.1038/s41591-021-01433-3. Epub 2021 Jun 23.

    PubMed 34163090

  • Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo PA, Cuapio A, Villapol S. More than 50 long-term effects of COVID-19: a systematic review and meta-analysis. Sci Rep. 2021 Aug 9;11(1):16144. doi: 10.1038/s41598-021-95565-8.

    PubMed 34373540

  • Jennings G, Monaghan A, Xue F, Mockler D, Romero-Ortuno R. A Systematic Review of Persistent Symptoms and Residual Abnormal Functioning following Acute COVID-19: Ongoing Symptomatic Phase vs. Post-COVID-19 Syndrome. J Clin Med. 2021 Dec 16;10(24):5913. doi: 10.3390/jcm10245913.

    PubMed 34945213

  • Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.

    PubMed 33428867

  • Zheng ZG, Sun WZ, Hu JY, Jie ZJ, Xu JF, Cao J, Song YL, Wang CH, Wang J, Zhao H, Guo ZL, Zhong NS. Hydrogen/oxygen therapy for the treatment of an acute exacerbation of chronic obstructive pulmonary disease: results of a multicenter, randomized, double-blind, parallel-group controlled trial. Respir Res. 2021 May 13;22(1):149. doi: 10.1186/s12931-021-01740-w.

    PubMed 33985501

  • Guan WJ, Wei CH, Chen AL, Sun XC, Guo GY, Zou X, Shi JD, Lai PZ, Zheng ZG, Zhong NS. Hydrogen/oxygen mixed gas inhalation improves disease severity and dyspnea in patients with Coronavirus disease 2019 in a recent multicenter, open-label clinical trial. J Thorac Dis. 2020 Jun;12(6):3448-3452. doi: 10.21037/jtd-2020-057. No abstract available.

    PubMed 32642277

  • Liu ST, Zhan C, Ma YJ, Guo CY, Chen W, Fang XM, Fang L. Effect of qigong exercise and acupressure rehabilitation program on pulmonary function and respiratory symptoms in patients hospitalized with severe COVID-19: a randomized controlled trial. Integr Med Res. 2021;10(Suppl):100796. doi: 10.1016/j.imr.2021.100796. Epub 2021 Oct 29.

    PubMed 34733607

  • Xiao CX, Lin YJ, Lin RQ, Liu AN, Zhong GQ, Lan CF. Effects of progressive muscle relaxation training on negative emotions and sleep quality in COVID-19 patients: A clinical observational study. Medicine (Baltimore). 2020 Nov 20;99(47):e23185. doi: 10.1097/MD.0000000000023185.

    PubMed 33217826

Questions about this trial

What is this clinical trial studying?

A study testing Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and basic treatment in people with COVID-19 and AMS-H-03, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuanlin Song, PhD (86-15021757762, ylsong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Borg score index from baseline at 3 months after the start of the study treatment. (time frame: Changes in Borg score assessed after the 6-minute walk test at 3 months (±7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05504460, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in