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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
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).
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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).
Time frame: Day 7of 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
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
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
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
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
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
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
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 2 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 3 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 5 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 7 of study treatment
Point reduction of WHO Clinical Progression Scale score
Point reduction of WHO Clinical Progression Scale score
Time frame: Day 10 of study treatment
Point reduction of WHO Clinical Progression Scale score
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
Changes in scores of COVID-19 related symptoms
Time frame: Day 2 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Time frame: Day 3 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Time frame: Day 5 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Time frame: Day 7 of the study treatment
Changes in scores of COVID-19 related symptoms
Changes in scores of COVID-19 related symptoms
Time frame: Day 10 of the study treatment
Changes in scores of COVID-19 related symptoms
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
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
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
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
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
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
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
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 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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 10 days
CRP
C-reactive protein
Time frame: Day 3 of study treatment
CRP
C-reactive protein
Time frame: Day 7 of study treatment
CRP
C-reactive protein
Time frame: Day 10 of study treatment
CRP
C-reactive protein
Time frame: through study completion, an average of 10 days
IL-6
IL-6
Time frame: Day 3 of study treatment
IL-6
IL-6
Time frame: Day 7 of study treatment
IL-6
IL-6
Time frame: Day 10 of study treatment
IL-6
IL-6
Time frame: through study completion, an average of 10 days
ferritin
ferritin
Time frame: Day 3 of study treatment
ferritin
ferritin
Time frame: Day 7 of study treatment
ferritin
ferritin
Time frame: Day 10 of study treatment
ferritin
ferritin
Time frame: through study completion, an average of 10 days
lymphocytes
lymphocytes
Time frame: Day 3 of study treatment
lymphocytes
lymphocytes
Time frame: Day 7of study treatment
lymphocytes
lymphocytes
Time frame: Day 10 of study treatment
lymphocytes
lymphocytes
Time frame: through study completion, an average of 10 days
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Time frame: Day 3 of study treatment
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Time frame: Day 7 of study treatment
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Time frame: Day 10 of study treatment
neutrophil to lymphocyte ratio
neutrophil to lymphocyte ratio
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 10 days
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