Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of COVID-19 Positive Patients

NCT05539664 | Unknown

• 1 other identifier: AMS-H-03-103
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, randomized, controlled, superiority clinical trial. It is expected that the test group would have better effectiveness than the control group in the primary evaluation indicator (time to negative viral nucleic acid detection from the start of study treatment). 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), and the control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment, to evaluate the effectiveness and safety of the investigational medical device Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients.

Conditions

Covid19; Hydrogen-oxygen Gas; AMS-H-03

Keywords

Covid19; Hydrogen-oxygen Gas; AMS-H-03

Outcome Measures

Primary Outcomes (1)

• Time to negative viral nucleic acid detection from the start of the study treatment.

  Time to negative viral nucleic acid detection is defined as two consecutive negative viral nucleic acid detections of respiratory specimens (samples will be taken at least 24 hours apart).

  through study completion, The average time from enrollment to two consecutive negative nucleic acid tests of respiratory specimens (sampling time interval of at least 24 hours) was approximately 7 days

Secondary Outcomes (9)

• Negative rate based on viral nucleic acid detection

  The negative rate of viral nucleic acid detection from 3, 5, 7, 10 days after the treatment to discharge will be analyzed.

• Imaging evalution indicators

  Lung imaging changes were analyzed on the 3rd and 7th day after treatment.

• CRP

  The changes were compared with those on day 3, 5 and 7 before treatment.

• Clinical effectiveness within 7 days

  The clinical effective rate after 7 days of treatment will be used as the evaluation indiactor

• recovery rate and time to recovery of main symptoms

  The patients will be followed up at 3, 5, 7, 10 days after the treatment and at discharge visit.

Other Outcomes (1)

• AE/SAE percentage

  through study completion, an average of 6 months

Study Arms (2)

experimental Group

EXPERIMENTAL

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)

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

Control Group

ACTIVE COMPARATOR

The control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment

Device: the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)

Interventions

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

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.

experimental Group

the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 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 80 years old (inclusive).
• 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.

You may not qualify if:

• Diagnosed as mild, severe, critical or asymptomatic type of COVID-19.
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (7)

• 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.

  PMID: 12690092 BACKGROUND

• 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.

  PMID: 12892955 BACKGROUND

• 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.

  PMID: 12690091 BACKGROUND

• 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.

  PMID: 23678167 BACKGROUND

• 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.

  PMID: 23075143 BACKGROUND

• 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.

  PMID: 30227423 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

Related Links

• 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.

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

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 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), and the control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: September 14, 2022
• Study Start: May 16, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-05

Locations

CN (1)