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

NCT05504460 | Unknown

• 1 other identifier: AMS-H-03-104
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

COVID-19; Hydrogen-Oxygen Generator with Nebulizer; AMS-H-03; Hydrogen-oxygen Gas

Outcome Measures

Primary Outcomes (2)

• 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.

  Changes in Borg score assessed after the 6-minute walk test at 3 months (±7 days)

• 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.

  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)

• Pulmonary function evaluation: FEV1

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

• Change in imaging evaluation

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

• Neurological and psychological function indicators including MMSE score

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

• Inflammatory indicators, including NLR

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

• Usability evaluation of the medical device

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

Other Outcomes (2)

• AE/SAE percentage

  through study completion, an average of 1 year

• Rate of device deficiency

  through study completion, an average of 1 year

Study Arms (2)

test group

EXPERIMENTAL

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)

Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03; Other: basic treatment

Control Group

ACTIVE COMPARATOR

the control group will use basic treatment only

Other: basic treatment

Interventions

Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 DEVICE

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).

test group

basic treatment OTHER

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

Control Group; test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 35411333 BACKGROUND

• 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.

  PMID: 34454673 BACKGROUND

• 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.

  PMID: 34163090 BACKGROUND

• 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.

  PMID: 34373540 BACKGROUND

• 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.

  PMID: 34945213 BACKGROUND

• 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.

  PMID: 33428867 BACKGROUND

• 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.

  PMID: 33985501 BACKGROUND

• 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.

  PMID: 32642277 BACKGROUND

• 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.

  PMID: 34733607 BACKGROUND

• 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.

  PMID: 33217826 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Yuanlin Song, PhD

CONTACT

86-15021757762; ylsong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: August 12, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

CN (1)