Back to resultsHydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of COVID-19 Positive Patients
Primary Purpose
Covid19, Hydrogen-oxygen Gas, AMS-H-03
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid19, Hydrogen-oxygen Gas, AMS-H-03
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Ruijin Hospital, Medical School of Shanghai Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental Group
Control Group
Arm 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)
The control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
CRP
Inflammatory indicators such as CRP
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.
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.
Oxygen saturation
Oxygen saturation
Ct value in nucleic acid detection
Ct value in nucleic acid detection
IL-6
Inflammatory indicators such as IL-6
lymphocytes
Inflammatory indicators such as lymphocytes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05539664
Brief Title
Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of COVID-19 Positive Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hydrogen-oxygen Gas, AMS-H-03
Keywords
Covid19, Hydrogen-oxygen Gas, AMS-H-03
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental Group
Arm Type
Experimental
Arm 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)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will use the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen) + basic treatment
Intervention Type
Device
Intervention Name(s)
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
the hospital routine oxygen supply equipment (wall oxygen or cylinder oxygen)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to negative viral nucleic acid detection from the start of the study treatment.
Description
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).
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
Secondary Outcome Measure Information:
Title
Negative rate based on viral nucleic acid detection
Description
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).
Time Frame
The negative rate of viral nucleic acid detection from 3, 5, 7, 10 days after the treatment to discharge will be analyzed.
Title
Imaging evalution indicators
Description
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.
Time Frame
Lung imaging changes were analyzed on the 3rd and 7th day after treatment.
Title
CRP
Description
Inflammatory indicators such as CRP
Time Frame
The changes were compared with those on day 3, 5 and 7 before treatment.
Title
Clinical effectiveness within 7 days
Description
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.
Time Frame
The clinical effective rate after 7 days of treatment will be used as the evaluation indiactor
Title
recovery rate and time to recovery of main symptoms
Description
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.
Time Frame
The patients will be followed up at 3, 5, 7, 10 days after the treatment and at discharge visit.
Title
Oxygen saturation
Description
Oxygen saturation
Time Frame
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.
Title
Ct value in nucleic acid detection
Description
Ct value in nucleic acid detection
Time Frame
This will be evaluated at1,2，3, 5, 7, and 10 days after the treatment and at discharge.
Title
IL-6
Description
Inflammatory indicators such as IL-6
Time Frame
The changes were compared with those on day 3, 5 and 7 before treatment.
Title
lymphocytes
Description
Inflammatory indicators such as lymphocytes
Time Frame
The changes were compared with those on day 3, 5 and 7 before treatment.
Other Pre-specified Outcome Measures:
Title
AE/SAE percentage
Description
AE/SAE percentage
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Ruijin Hospital, Medical School of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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12690092
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Results Reference
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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.
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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. Erratum In: N Engl J Med. 2013 Jul 25;369(4):394.
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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.
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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. Erratum In: J Thorac Dis. 2020 Aug;12(8):4591-4592.
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Links:
URL
https://www.who.int/csr/sars/country/table2004_04_21/en/
Description
WHO. Summary of probable SARS cases with onset of illness from 1 November 2002 to 31 July 2003. Dec 31, 2003.
URL
http://www.who.int/emergencies/mers-cov/en/
Description
WHO. Middle East respiratory syndrome coronavirus (MERS-CoV). November, 2019.
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Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of COVID-19 Positive Patients
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