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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
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.
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.
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
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).
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
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).
Time frame: The negative rate of viral nucleic acid detection from 3, 5, 7, 10 days after the treatment to discharge will be analyzed.
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.
Time frame: Lung imaging changes were analyzed on the 3rd and 7th day after treatment.
CRP
Inflammatory indicators such as CRP
Time frame: The changes were compared with those on day 3, 5 and 7 before treatment.
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.
Time frame: The clinical effective rate after 7 days of treatment will be used as the evaluation indiactor
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.
Time frame: The patients will be followed up at 3, 5, 7, 10 days after the treatment and at discharge visit.
Oxygen saturation
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.
Ct value in nucleic acid detection
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.
IL-6
Inflammatory indicators such as IL-6
Time frame: The changes were compared with those on day 3, 5 and 7 before treatment.
lymphocytes
Inflammatory indicators such as lymphocytes
Time frame: The changes were compared with those on day 3, 5 and 7 before treatment.
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