Back to resultsHydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
Primary Purpose
Covid19, Hydrogen-oxygen Gas, AMS-H-03
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
OLO-1 Medical Molecular Sieve Oxygen Generator
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 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. Exclusion Criteria: 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. 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.
Sites / Locations
- First Affiliated Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental Group
Control Group
Arm Description
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);
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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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
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
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
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
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
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
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Total length of hospital stay
Total length of hospital stay
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
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
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
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
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
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
CRP
C-reactive protein
CRP
C-reactive protein
CRP
C-reactive protein
CRP
C-reactive protein
IL-6
IL-6
IL-6
IL-6
IL-6
IL-6
IL-6
IL-6
ferritin
ferritin
ferritin
ferritin
ferritin
ferritin
ferritin
ferritin
lymphocytes
lymphocytes
lymphocytes
lymphocytes
lymphocytes
lymphocytes
lymphocytes
lymphocytes
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
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
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
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
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
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
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
Full Information
NCT ID
NCT05770206
First Posted
February 23, 2023
Last Updated
March 12, 2023
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT05770206
Brief Title
Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
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 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.
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
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental Group
Arm Type
Experimental
Arm Description
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);
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03
Intervention Description
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);
Intervention Type
Device
Intervention Name(s)
OLO-1 Medical Molecular Sieve Oxygen Generator
Intervention Description
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).
Primary Outcome Measure Information:
Title
the percentage of subjects with clinical recovery on Day 7 of study treatment.
Description
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).
Time Frame
Day 7of study treatment
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving clinical recovery
Description
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).
Time Frame
Day 2of study treatment
Title
Percentage of subjects achieving clinical recovery
Description
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).
Time Frame
Day 3 of study treatment
Title
Percentage of subjects achieving clinical recovery
Description
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).
Time Frame
Day 5of study treatment
Title
Percentage of subjects achieving clinical recovery
Description
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).
Time Frame
Day 10 of study treatment
Title
Percentage of subjects achieving clinical recovery
Description
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).
Time Frame
through study completion, an average of 10 days
Title
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Description
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time Frame
Day 2 of study treatment
Title
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Description
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time Frame
Day 3 of study treatment
Title
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Description
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time Frame
Day 5 of study treatment
Title
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Description
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time Frame
Day 7 of study treatment
Title
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Description
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Time Frame
Day 10 of study treatment
Title
Percentage of subjects whose WHO Clinical Progression Scale score decreased by 1 point or more
Description
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
Title
Point reduction of WHO Clinical Progression Scale score
Description
Point reduction of WHO Clinical Progression Scale score
Time Frame
Day 2 of study treatment
Title
Point reduction of WHO Clinical Progression Scale score
Description
Point reduction of WHO Clinical Progression Scale score
Time Frame
Day 3 of study treatment
Title
Point reduction of WHO Clinical Progression Scale score
Description
Point reduction of WHO Clinical Progression Scale score
Time Frame
Day 5 of study treatment
Title
Point reduction of WHO Clinical Progression Scale score
Description
Point reduction of WHO Clinical Progression Scale score
Time Frame
Day 7 of study treatment
Title
Point reduction of WHO Clinical Progression Scale score
Description
Point reduction of WHO Clinical Progression Scale score
Time Frame
Day 10 of study treatment
Title
Point reduction of WHO Clinical Progression Scale score
Description
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
Title
Changes in scores of COVID-19 related symptoms
Description
Changes in scores of COVID-19 related symptoms
Time Frame
Day 2 of the study treatment
Title
Changes in scores of COVID-19 related symptoms
Description
Changes in scores of COVID-19 related symptoms
Time Frame
Day 3 of the study treatment
Title
Changes in scores of COVID-19 related symptoms
Description
Changes in scores of COVID-19 related symptoms
Time Frame
Day 5 of the study treatment
Title
Changes in scores of COVID-19 related symptoms
Description
Changes in scores of COVID-19 related symptoms
Time Frame
Day 7 of the study treatment
Title
Changes in scores of COVID-19 related symptoms
Description
Changes in scores of COVID-19 related symptoms
Time Frame
Day 10 of the study treatment
Title
Changes in scores of COVID-19 related symptoms
Description
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
Title
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Description
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time Frame
Day 2 of the study treatment
Title
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Description
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time Frame
Day 3 of the study treatment
Title
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Description
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time Frame
Day 5 of the study treatment
Title
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Description
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time Frame
Day 7 of the study treatment
Title
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Description
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time Frame
Day 10 of the study treatment
Title
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Description
Percentage of subjects whose COVID-19 related symptoms have recovered to normal
Time Frame
through study completion, an average of 10 days
Title
Total length of hospital stay
Description
Total length of hospital stay
Time Frame
through study completion, an average of 14 days
Title
Time from randomization to conversion to mild type of COVID-19
Description
Time from randomization to conversion to mild type of COVID-19
Time Frame
Time from randomization to conversion to mild type of COVID-19
Title
Oxygen saturation in resting non-oxygen inhalation state
Description
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
Time Frame
Day 2 of study treatment
Title
Oxygen saturation in resting non-oxygen inhalation state
Description
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
Time Frame
Day 3 of study treatment
Title
Oxygen saturation in resting non-oxygen inhalation state
Description
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
Time Frame
Day 5 of study treatment
Title
Oxygen saturation in resting non-oxygen inhalation state
Description
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
Time Frame
Day 7 of study treatment
Title
Oxygen saturation in resting non-oxygen inhalation state
Description
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
Time Frame
Day 10 of study treatment
Title
Oxygen saturation in resting non-oxygen inhalation state
Description
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
Time Frame
through study completion, an average of 10 days
Title
CRP
Description
C-reactive protein
Time Frame
Day 3 of study treatment
Title
CRP
Description
C-reactive protein
Time Frame
Day 7 of study treatment
Title
CRP
Description
C-reactive protein
Time Frame
Day 10 of study treatment
Title
CRP
Description
C-reactive protein
Time Frame
through study completion, an average of 10 days
Title
IL-6
Description
IL-6
Time Frame
Day 3 of study treatment
Title
IL-6
Description
IL-6
Time Frame
Day 7 of study treatment
Title
IL-6
Description
IL-6
Time Frame
Day 10 of study treatment
Title
IL-6
Description
IL-6
Time Frame
through study completion, an average of 10 days
Title
ferritin
Description
ferritin
Time Frame
Day 3 of study treatment
Title
ferritin
Description
ferritin
Time Frame
Day 7 of study treatment
Title
ferritin
Description
ferritin
Time Frame
Day 10 of study treatment
Title
ferritin
Description
ferritin
Time Frame
through study completion, an average of 10 days
Title
lymphocytes
Description
lymphocytes
Time Frame
Day 3 of study treatment
Title
lymphocytes
Description
lymphocytes
Time Frame
Day 7of study treatment
Title
lymphocytes
Description
lymphocytes
Time Frame
Day 10 of study treatment
Title
lymphocytes
Description
lymphocytes
Time Frame
through study completion, an average of 10 days
Title
neutrophil to lymphocyte ratio
Description
neutrophil to lymphocyte ratio
Time Frame
Day 3 of study treatment
Title
neutrophil to lymphocyte ratio
Description
neutrophil to lymphocyte ratio
Time Frame
Day 7 of study treatment
Title
neutrophil to lymphocyte ratio
Description
neutrophil to lymphocyte ratio
Time Frame
Day 10 of study treatment
Title
neutrophil to lymphocyte ratio
Description
neutrophil to lymphocyte ratio
Time Frame
through study completion, an average of 10 days
Title
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Description
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Time Frame
Day 2 of study treatment
Title
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Description
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Time Frame
Day 3 of study treatment
Title
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Description
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Time Frame
Day 5 of study treatment
Title
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Description
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Time Frame
Day 7 of study treatment
Title
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Description
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Time Frame
Day 10 of study treatment
Title
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Description
Percentage of patients with fever, shortness of breath and chest pain all disappeared
Time Frame
through study completion, an average of 10 days
Other Pre-specified Outcome Measures:
Title
Incidence of AEs/SAEs
Description
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
Time Frame
through study completion, an average of 14 days
Title
Incidence of Device Deficiency
Description
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.
Time Frame
through study completion, an average of 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guan Wei-jie, PhD
Phone
+86-13826042052
Email
battery203@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guan Weijie, PhD
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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12690092
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Learn more about this trial
Hydrogen-Oxygen Generator With Nebulizer for Adjuvant Treatment of Novel Coronavirus Disease 2019 (COVID-19)
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