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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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); |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03 | Device | 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); |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 7of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs/SAEs | Definition: An AE is defined as any untoward medical occurrence during the course of the clinical trial, whether or not related to the study device. For the definition of SAE | through study completion, an average of 14 days |
| Incidence of Device Deficiency |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guan Wei-jie, PhD | Contact | +86-13826042052 | battery203@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guan Weijie, PhD | Guangzhou Institute of Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12690092 | Background | 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. | |
| 12892955 |
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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).
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|
| OLO-1 Medical Molecular Sieve Oxygen Generator | Device | 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). |
|
| 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). | 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). | 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). | 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). | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Day 2 of study treatment |
| Point reduction of WHO Clinical Progression Scale score | Point reduction of WHO Clinical Progression Scale score | Day 3 of study treatment |
| Point reduction of WHO Clinical Progression Scale score | Point reduction of WHO Clinical Progression Scale score | Day 5 of study treatment |
| Point reduction of WHO Clinical Progression Scale score | Point reduction of WHO Clinical Progression Scale score | Day 7 of study treatment |
| Point reduction of WHO Clinical Progression Scale score | Point reduction of WHO Clinical Progression Scale score | Day 10 of study treatment |
| Point reduction of WHO Clinical Progression Scale score | Point reduction of WHO Clinical Progression Scale score | 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 | Day 2 of the study treatment |
| Changes in scores of COVID-19 related symptoms | Changes in scores of COVID-19 related symptoms | Day 3 of the study treatment |
| Changes in scores of COVID-19 related symptoms | Changes in scores of COVID-19 related symptoms | Day 5 of the study treatment |
| Changes in scores of COVID-19 related symptoms | Changes in scores of COVID-19 related symptoms | Day 7 of the study treatment |
| Changes in scores of COVID-19 related symptoms | Changes in scores of COVID-19 related symptoms | Day 10 of the study treatment |
| Changes in scores of COVID-19 related symptoms | Changes in scores of COVID-19 related symptoms | 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 | 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 | 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 | 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 | 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 | 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 | through study completion, an average of 10 days |
| Total length of hospital stay | Total length of hospital stay | 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 | 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 | 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 | 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 | 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 | 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 | 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 | through study completion, an average of 10 days |
| CRP | C-reactive protein | Day 3 of study treatment |
| CRP | C-reactive protein | Day 7 of study treatment |
| CRP | C-reactive protein | Day 10 of study treatment |
| CRP | C-reactive protein | through study completion, an average of 10 days |
| IL-6 | IL-6 | Day 3 of study treatment |
| IL-6 | IL-6 | Day 7 of study treatment |
| IL-6 | IL-6 | Day 10 of study treatment |
| IL-6 | IL-6 | through study completion, an average of 10 days |
| ferritin | ferritin | Day 3 of study treatment |
| ferritin | ferritin | Day 7 of study treatment |
| ferritin | ferritin | Day 10 of study treatment |
| ferritin | ferritin | through study completion, an average of 10 days |
| lymphocytes | lymphocytes | Day 3 of study treatment |
| lymphocytes | lymphocytes | Day 7of study treatment |
| lymphocytes | lymphocytes | Day 10 of study treatment |
| lymphocytes | lymphocytes | through study completion, an average of 10 days |
| neutrophil to lymphocyte ratio | neutrophil to lymphocyte ratio | Day 3 of study treatment |
| neutrophil to lymphocyte ratio | neutrophil to lymphocyte ratio | Day 7 of study treatment |
| neutrophil to lymphocyte ratio | neutrophil to lymphocyte ratio | Day 10 of study treatment |
| neutrophil to lymphocyte ratio | neutrophil to lymphocyte ratio | 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 | 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 | 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 | 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 | 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 | 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 | through study completion, an average of 10 days |
Definition: a device deficiency is defined as any inadequacy of a medical device which may pose inappropriate risks to the health or safety of the subjects under normal use of the device during the clinical trial, including inadequate labelling, quality issue, and malfunctions, etc. |
| through study completion, an average of 14 days |
| 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. |
| 12690091 | 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. |
| 23678167 | 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. |
| 23075143 | 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. |
| 30227423 | 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. |
| 33985501 | 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. |
| 32642277 | 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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