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Covid19NCT05539664

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

A study testing Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) in people with Covid19 and Hydrogen-oxygen Gas, run by Ruijin 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Covid19, Hydrogen-oxygen Gas, AMS-H-03
What is being tested?
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteChina
Study dates
16 May 2022to 30 Dec 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Medical School of Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Prospective, Multi-center, Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of 2019 Novel Coronavirus Pneumonia (COVID-19) Positive Patients

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.

Read the detailed description

A total of 188 subjects who met the requirements of this study will be randomized into the test group or the control group in a 1:1 ratio to receive treatment, and the subjects will be observed and evaluated in the period from treatment after enrollment to discharge.

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.

Being tested
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)
Keywords
Covid19, Hydrogen-oxygen Gas, AMS-H-03
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

    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)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.

Study groups in NCT05539664
Study groupRoleWhat they receive
experimental GroupExperimentalThe 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)
Receives: Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
Control GroupActive comparatorThe control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment
Receives: Device: the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)

What is being measured

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

  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).

    Measured: 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)

  1. Negative rate based on viral nucleic acid detection

    Negative viral nucleic acid detection is defined as two consecutive negative nucleic acid detections of respiratory specimens (the sampling time interval will be at least 24 hours).

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

  2. Imaging evalution indicators

    Significant lesion absorption >50%, lesion absorption degree of 10%-50%, lesion absorption degree of < 10%, and lesion progression compared with that at enrollment as showed in lung imaging.

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

  3. CRP

    Inflammatory indicators such as CRP

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

  4. Clinical effectiveness within 7 days

    Clinically effective is defined as "cured" + "significant effective" + "effective". Clinical response rate = (total number of patients of "cured" + "significant effective" + "effective")/total number of subjects included in the analysis ×100%. It should be noted that in the actual situation, some clinical symptoms or signs may still be observed in the follow up after the end of treatment. If it is indicated that the above situation is resulted from the underlying disease, the investigator can also consider the patient to be clinically cured after comprehensive judgment based on the clinical data.

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

  5. recovery rate and time to recovery of main symptoms

    It is defined as all major symptoms (fever, fatigue, cough, expectoration, chest tightness, chest pain, shortness of breath, and dyspnea) at enrollment had all disappeared or completely returned to normal at follow up.

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

  6. Oxygen saturation

    Oxygen saturation

    Measured: This will be evaluated at 3, 5, 7, and 10 days after the treatment and at discharge. The oxygen saturation will be measured at rest after stopping oxygen or hydrogen inhalation for 10 minutes.

  7. Ct value in nucleic acid detection

    Ct value in nucleic acid detection

    Measured: This will be evaluated at1,2，3, 5, 7, and 10 days after the treatment and at discharge.

  8. IL-6

    Inflammatory indicators such as IL-6

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

  9. lymphocytes

    Inflammatory indicators such as lymphocytes

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

Timeline

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

  1. First posted14 Sep 2022
  2. Study start16 May 2022
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (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 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
Masking
None (open label)
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05539664
Sponsor's protocol ID
AMS-H-03-103
Status last verified
May 2022
First submitted
14 Aug 2022
Last updated
14 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 12690092

  • 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.

    PubMed 12892955

  • 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.

    PubMed 12690091

  • 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.

    PubMed 23678167

  • 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.

    PubMed 23075143

  • 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.

    PubMed 30227423

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) in people with Covid19 and Hydrogen-oxygen Gas, run by Ruijin 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 3 inclusion and 10 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 14 Sep 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to negative viral nucleic acid detection from the start of the study treatment. (time frame: 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). 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 NCT05539664, which also lists 7 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 14 Sep 2022.

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