Covid19NCT05770206
Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
A study testing Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and OLO-1 Medical Molecular Sieve Oxygen Generator in people with Covid19 and Hydrogen-oxygen Gas, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This is a multi-center, randomized, parallel controlled, double-blinded clinical trial to evaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 to 75 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 OLO-1 Medical Molecular Sieve Oxygen Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 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 or female subjects aged between 18 and 75 years old (inclusive).
- Diagnosed with mild, moderate or severe type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 10).
- Positive result for COVID-19 nucleic acid test or rapid antigen detection at screening visit;
- Presenting with at least one respiratory symptom (e.g. dyspnoea, shortness of breath) at hospital admission.
- Be willing to participate in this trial and provide written informed consent form.
Who cannot join
- Subjects with critical or asymptomatic type of COVID-19;
- Subjects with any known malignant tumor or life expectancy less than half a year.
- 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 with any serious cardiac, hepatic or renal disease (as indicated by aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≥ 2 × upper limit of normal [ULN], or creatinine ≥ 176.8mmol/L, or New York Heart Association (NYHA) Classification for heart failure of Class IV) or any serious primary systematic disease.
Show all 10Show fewer
- Subjects who are going to use any non-expectorant antioxidant drug, including large doses of vitamin C and vitamin E during the study period.
- Subjects who are participating in any other clinical study on any investigational drug or medical device.
- Pregnant or lactating women.
- Subjects with 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
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: A Multi-center, Randomized, Parallel Controlled, Double-Blinded Clinical Trial to Evaluate the Effectiveness and Safety of Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
This is a multi-center, randomized, parallel controlled, double-blinded clinical trial to evaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients. The test group is expected to be superior to the control group in the primary endpoint (percentage of subjects achieving clinical recovery at Day 7 of study treatment). Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); and subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
Read the detailed description
Data of the following effectiveness and safety endpoints of subjects in the two groups will be collected and analyzed in this study, including of the primary effectiveness endpoint: percentage of subjects achieving clinical recovery at Day 7 of study treatment; and the secondary effectiveness endpoints: percentage of subjects achieving clinical recovery on Day 2, 3, 5, 10 of study treatment and that before discharge; percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more on Day 2, 3, 5, 7, 10 of study treatment and before discharge; reduction of WHO Clinical Progression Scale score on Day 2, 3, 5, 7, 10 of study treatment and before discharge; changes in COVID-19 symptom scores on Day 2, 3, 5, 7, 10 of study treatment and before discharge; total length of hospital stay; time from randomization to conversion to general COVID-19; time from randomization to conversion to mild COVID-19 disease; percentage of patients with no fever, shortness of breath and chest pain on Day 2, 3, 5, 7, 10 of study treatment and before discharge; Oxygen saturation based on finger blood samples in resting non-oxygen inhalation state; and safety evaluation variables including incidences of AEs, SAEs and device deficiencies.
- Conditions
- Covid19, Hydrogen-oxygen Gas, AMS-H-03
- Being tested
- Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, OLO-1 Medical Molecular Sieve Oxygen Generator
- 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
Subjects in the experimental group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects);
OLO-1 Medical Molecular Sieve Oxygen GeneratorDevice
subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
| Study group | Role | What they receive |
|---|---|---|
| experimental Group | Experimental | Subjects in the experimental group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); Receives: Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 |
| Control Group | Active comparator | subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group). Receives: Device: OLO-1 Medical Molecular Sieve Oxygen Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of subjects with clinical recovery on Day 7 of study treatment.
continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first).
Measured: Day 7of study treatment
Secondary outcomes (63)
Percentage of subjects achieving clinical recovery
continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first).
Measured: Day 2of study treatment
Percentage of subjects achieving clinical recovery
continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first).
Measured: Day 3 of study treatment
Percentage of subjects achieving clinical recovery
continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first).
Measured: Day 5of study treatment
Percentage of subjects achieving clinical recovery
continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first).
Measured: Day 10 of study treatment
Percentage of subjects achieving clinical recovery
continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first).
Measured: through study completion, an average of 10 days
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Measured: Day 2 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Measured: Day 3 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Measured: Day 5 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Measured: Day 7 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Measured: Day 10 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Measured: The period from the beginning of treatment in patients enrolled to the time before discharge
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Measured: Day 2 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Measured: Day 3 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Measured: Day 5 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Measured: Day 7 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Measured: Day 10 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Measured: The period from the beginning of treatment in patients enrolled to the time before discharge
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Measured: Day 2 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Measured: Day 3 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Measured: Day 5 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Measured: Day 7 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Measured: Day 10 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Measured: The period from the beginning of treatment in patients enrolled to the time before discharge
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Measured: Day 2 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Measured: Day 3 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Measured: Day 5 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Measured: Day 7 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Measured: Day 10 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Measured: through study completion, an average of 10 days
Total length of hospital stay
Total length of hospital stay
Measured: through study completion, an average of 14 days
Time from randomization to conversion to mild type of COVID-19
Time from randomization to conversion to mild type of COVID-19
Measured: Time from randomization to conversion to mild type of COVID-19
Oxygen saturation in resting non-oxygen inhalation state
Oxygen saturation will be measured based on finger blood samples in resting state at 10 minutes after stopping the use of the study device for subjects in the test group and the control group
Measured: Day 2 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Oxygen saturation will be measured based on finger blood samples in resting state at 10 minutes after stopping the use of the study device for subjects in the test group and the control group
Measured: Day 3 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Oxygen saturation will be measured based on finger blood samples in resting state at 10 minutes after stopping the use of the study device for subjects in the test group and the control group
Measured: Day 5 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Oxygen saturation will be measured based on finger blood samples in resting state at 10 minutes after stopping the use of the study device for subjects in the test group and the control group
Measured: Day 7 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Oxygen saturation will be measured based on finger blood samples in resting state at 10 minutes after stopping the use of the study device for subjects in the test group and the control group
Measured: Day 10 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Oxygen saturation will be measured based on finger blood samples in resting state at 10 minutes after stopping the use of the study device for subjects in the test group and the control group
Measured: through study completion, an average of 10 days
CRP
C-reactive protein
Measured: Day 3 of study treatment
CRP
C-reactive protein
Measured: Day 7 of study treatment
CRP
C-reactive protein
Measured: Day 10 of study treatment
CRP
C-reactive protein
Measured: through study completion, an average of 10 days
IL-6
IL-6
Measured: Day 3 of study treatment
IL-6
IL-6
Measured: Day 7 of study treatment
IL-6
IL-6
Measured: Day 10 of study treatment
IL-6
IL-6
Measured: through study completion, an average of 10 days
ferritin
ferritin
Measured: Day 3 of study treatment
ferritin
ferritin
Measured: Day 7 of study treatment
ferritin
ferritin
Measured: Day 10 of study treatment
ferritin
ferritin
Measured: through study completion, an average of 10 days
lymphocytes
lymphocytes
Measured: Day 3 of study treatment
lymphocytes
lymphocytes
Measured: Day 7of study treatment
lymphocytes
lymphocytes
Measured: Day 10 of study treatment
lymphocytes
lymphocytes
Measured: through study completion, an average of 10 days
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Measured: Day 3 of study treatment
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Measured: Day 7 of study treatment
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Measured: Day 10 of study treatment
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Measured: through study completion, an average of 10 days
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Measured: Day 2 of study treatment
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Measured: Day 3 of study treatment
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Measured: Day 5 of study treatment
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Measured: Day 7 of study treatment
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Measured: Day 10 of study treatment
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Measured: through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijie Guan, Guangzhou Institute of Respiratory Disease
- Investigators
- Guan Weijie, PhD, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770206
- Sponsor's protocol ID
- AMS-H-03-105
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 15 Mar 2023
- 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 12690092Kuiken 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 12892955Drosten 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 12690091de 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 23678167Zaki 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 23075143Zhou 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 30227423Zheng 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 33985501Guan 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Parallel Controlled, Double-Blinded Clinical Trial to Evaluate the Effectiveness and Safety of Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT05770206
- Acronym / sponsor ID
- AMS-H-03-105
- Conditions
- Covid19, Hydrogen-oxygen Gas, AMS-H-03
- Keywords
- Covid19, Hydrogen-oxygen Gas, AMS-H-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, parallel controlled, double-blinded clinical trial to evaluate the effectiveness and safety of Hydrogen-Oxygen Generator with Nebulizer for adjuvant treatment of COVID-19 patients. The test group is expected to be superior to the control group in the primary endpoint (percentage of subjects achieving clinical recovery at Day 7 of study treatment). Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); and subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
Detailed description
Data of the following effectiveness and safety endpoints of subjects in the two groups will be collected and analyzed in this study, including of the primary effectiveness endpoint: percentage of subjects achieving clinical recovery at Day 7 of study treatment; and the secondary effectiveness endpoints: percentage of subjects achieving clinical recovery on Day 2, 3, 5, 10 of study treatment and that before discharge; percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more on Day 2, 3, 5, 7, 10 of study treatment and before discharge; reduction of WHO Clinical Progression Scale score on Day 2, 3, 5, 7, 10 of study treatment and before discharge; changes in COVID-19 symptom scores on Day 2, 3, 5, 7, 10 of study treatment and before discharge; total length of hospital stay; time from randomization to conversion to general COVID-19; time from randomization to conversion to mild COVID-19 disease; percentage of patients with no fever, shortness of breath and chest pain on Day 2, 3, 5, 7, 10 of study treatment and before discharge; Oxygen saturation based on finger blood samples in resting non-oxygen inhalation state; and safety evaluation variables including incidences of AEs, SAEs and device deficiencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects in the test group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); subjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group).
| Arm | Type | Receives |
|---|---|---|
| experimental Group | Experimental | Device: Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03Subjects in the experimental group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); |
| Control Group | Active comparator | Device: OLO-1 Medical Molecular Sieve Oxygen Generatorsubjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged between 18 and 75 years old (inclusive).
- Diagnosed with mild, moderate or severe type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 10).
- Positive result for COVID-19 nucleic acid test or rapid antigen detection at screening visit;
- Presenting with at least one respiratory symptom (e.g. dyspnoea, shortness of breath) at hospital admission.
- Be willing to participate in this trial and provide written informed consent form.
Key exclusion criteria (10 listed)
- Subjects with critical or asymptomatic type of COVID-19;
- Subjects with any known malignant tumor or life expectancy less than half a year.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03Subjects in the experimental group will receive treatment by using Hydrogen-Oxygen Generator with Nebulizer (manufactured by Shanghai Asclepius Meditec Co., Ltd., flow rate: 3L/min) combined with conventional basic supportive treatment (symptomatic support treatment determined by the investigator based on the condition of the subjects); | Device | experimental Group |
| OLO-1 Medical Molecular Sieve Oxygen Generatorsubjects in the control group will receive treatment by using Medical Molecular Sieve Oxygen Generator (manufactured by Shanghai Ouliang Medical Devices Co., Ltd., flow rate: 3L/min, provided by the sponsor) combined with conventional basic supportive treatment (same with that in the test group). | Device | Control Group |
Primary outcome
the percentage of subjects with clinical recovery on Day 7 of study treatment.
Time frame: Day 7of study treatment
continuous clinical recovery is defined as score (see Appendix 2) of COVID-19 related symptoms ≤ 1 continued for 2 consecutive days or discharge criteria is met. Time of continuous clinical recovery is defined as time (days) between the first initiation of the study treatment devices and the time when the score of relevant COVID-19 related symptoms ≤ 1 continues for 2 consecutive days or discharge criteria is met (whichever comes first).
63 secondary outcomes
Percentage of subjects achieving clinical recovery
Time frame: Day 2of study treatment
Percentage of subjects achieving clinical recovery
Time frame: Day 3 of study treatment
Percentage of subjects achieving clinical recovery
Time frame: Day 5of study treatment
Percentage of subjects achieving clinical recovery
Time frame: Day 10 of study treatment
Percentage of subjects achieving clinical recovery
Time frame: through study completion, an average of 10 days
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time frame: Day 2 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time frame: Day 3 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time frame: Day 5 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time frame: Day 7 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time frame: Day 10 of study treatment
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time frame: The period from the beginning of treatment in patients enrolled to the time before discharge
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 2 of study treatment
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 3 of study treatment
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 5 of study treatment
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 7 of study treatment
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 10 of study treatment
Point reduction of WHO Clinical Progression Scale score
Time frame: The period from the beginning of treatment in patients enrolled to the time before discharge
Changes in scores of COVID-19 related symptoms
Time frame: Day 2 of the study treatment
Changes in scores of COVID-19 related symptoms
Time frame: Day 3 of the study treatment
Changes in scores of COVID-19 related symptoms
Time frame: Day 5 of the study treatment
Changes in scores of COVID-19 related symptoms
Time frame: Day 7 of the study treatment
Changes in scores of COVID-19 related symptoms
Time frame: Day 10 of the study treatment
Changes in scores of COVID-19 related symptoms
Time frame: The period from the beginning of treatment in patients enrolled to the time before discharge
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time frame: Day 2 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time frame: Day 3 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time frame: Day 5 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time frame: Day 7 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time frame: Day 10 of the study treatment
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time frame: through study completion, an average of 10 days
Total length of hospital stay
Time frame: through study completion, an average of 14 days
Time from randomization to conversion to mild type of COVID-19
Time frame: Time from randomization to conversion to mild type of COVID-19
Oxygen saturation in resting non-oxygen inhalation state
Time frame: Day 2 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Time frame: Day 3 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Time frame: Day 5 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Time frame: Day 7 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Time frame: Day 10 of study treatment
Oxygen saturation in resting non-oxygen inhalation state
Time frame: through study completion, an average of 10 days
CRP
Time frame: Day 3 of study treatment
CRP
Time frame: Day 7 of study treatment
CRP
Time frame: Day 10 of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 12690092Ksiazek 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.
- Background: PubMed 12892955Kuiken 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.
- Background: PubMed 12690091Drosten 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.
- Background: PubMed 23678167de 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.
- Background: PubMed 23075143Zaki 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.
- Background: PubMed 30227423Zhou 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.
- Background: PubMed 33985501Zheng 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.
- Background: PubMed 32642277Guan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guan Weijie, PhD principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 and OLO-1 Medical Molecular Sieve Oxygen Generator in people with Covid19 and Hydrogen-oxygen Gas, run by Guangzhou Institute of Respiratory Disease 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 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 15 Mar 2023. 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 Guan Wei-jie, PhD (+86-13826042052, battery203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of subjects with clinical recovery on Day 7 of study treatment. (time frame: Day 7of study treatment). 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 NCT05770206, which also lists 8 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 15 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.