Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of COVID-19 Positive Patients
NCT ID: NCT05539664
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
188 participants
INTERVENTIONAL
2022-05-16
2022-12-30
Brief Summary
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Detailed Description
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All enrolled subjects will receive treatment and visit, including screening visit (within 3 days before enrollment), randomization and treatment visit (Day 0), 1, 2, 3, 5, 7, 10, and discharge visit after treatment.
The primary effectiveness evaluation indicator (time to negative viral nucleic acid detection from the start of the study treatment), the secondary effectiveness evaluation indicators (viral nucleic acid negative conversion rate, imaging evaluation, inflammatory indicators such as CRP, IL-6, lymphocytes, clinical response rate at 7 days of treatment, recovery rate and recovery time of major symptoms, index oxygen saturation, and Ct value of nucleic acid detection), and safety evaluation indicators ( incidence of AE and SAE, incidence of device deficiencies) of the two groups will be collected and analyzed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental Group
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)
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
The experimental group used the experimental medical device Hydrogen-Oxygen Generator with Nebulizer(Shanghai Asclepius Meditec Co., Ltd. ) The flow rate was 3L/min, and the cumulative treatment time was not less than 6 hours per day.
Control Group
The control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment
the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)
the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen). The flow rate was 3L/min, and the cumulative treatment time was not less than 6 hours per day.
Interventions
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Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
The experimental group used the experimental medical device Hydrogen-Oxygen Generator with Nebulizer(Shanghai Asclepius Meditec Co., Ltd. ) The flow rate was 3L/min, and the cumulative treatment time was not less than 6 hours per day.
the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)
the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen). The flow rate was 3L/min, and the cumulative treatment time was not less than 6 hours per day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Locations
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Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Countries
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References
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Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. doi: 10.1056/NEJMoa030781. Epub 2003 Apr 10.
Kuiken T, Fouchier RA, Schutten M, Rimmelzwaan GF, van Amerongen G, van Riel D, Laman JD, de Jong T, van Doornum G, Lim W, Ling AE, Chan PK, Tam JS, Zambon MC, Gopal R, Drosten C, van der Werf S, Escriou N, Manuguerra JC, Stohr K, Peiris JS, Osterhaus AD. Newly discovered coronavirus as the primary cause of severe acute respiratory syndrome. Lancet. 2003 Jul 26;362(9380):263-70. doi: 10.1016/S0140-6736(03)13967-0.
Drosten C, Gunther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguiere AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Muller S, Rickerts V, Sturmer M, Vieth S, Klenk HD, Osterhaus AD, Schmitz H, Doerr HW. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1967-76. doi: 10.1056/NEJMoa030747. Epub 2003 Apr 10.
de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, Fouchier RA, Galiano M, Gorbalenya AE, Memish ZA, Perlman S, Poon LL, Snijder EJ, Stephens GM, Woo PC, Zaki AM, Zambon M, Ziebuhr J. Middle East respiratory syndrome coronavirus (MERS-CoV): announcement of the Coronavirus Study Group. J Virol. 2013 Jul;87(14):7790-2. doi: 10.1128/JVI.01244-13. Epub 2013 May 15. No abstract available.
Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17.
Zhou ZQ, Zhong CH, Su ZQ, Li XY, Chen Y, Chen XB, Tang CL, Zhou LQ, Li SY. Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis. Respiration. 2019;97(1):42-51. doi: 10.1159/000492031. Epub 2018 Sep 18.
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.
Related Links
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WHO. Summary of probable SARS cases with onset of illness from 1 November 2002 to 31 July 2003. Dec 31, 2003.
WHO. Middle East respiratory syndrome coronavirus (MERS-CoV). November, 2019.
Other Identifiers
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AMS-H-03-103
Identifier Type: -
Identifier Source: org_study_id
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