Hydrogen-Oxygen Generator With Nebulizer in the Improvement of Symptoms in Patients Infected With COVID-19 (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04336462|
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Device: oxyhydrogen Device: Oxygen||Not Applicable|
A multi-center, randomized, parallel-controlled clinical trial design is used in this study.
Eligible subjects will be randomized into the study group and control group in a 1:1 ratio. In addition to the supportive treatments depending on the condition, the subjects in the study group will inhale the mixed gas of hydrogen/oxygen (hydrogen concentration 66%, oxygen concentration 33%) at a flow rate of 6 L/min every day using the Hydrogen/Oxygen Generator with Nebulizer (model AMS-H-03) developed by Shanghai Asclepius Meditech Co., Ltd. during the treatment, with the total use of no less than 6 hours per day, and the other combination treatments will be decided by the investigator depending on the clinical needs; the subjects in the control group will inhale the gas at a flow rate of 2 L/min every day using the reference device of EverFlo Oxygen Concentrator (registration certificate No.: NMPA Registration Standard: 20162542389) developed by Respironics, Inc. US. during the treatment, with the total use of no less than 6 hours per day, and the other combination treatments will be decided by the investigator depending on the clinical needs. During the treatment, the peripheral blood oxygen saturation should be monitored and the oxygen concentration should be increased when necessary (the peripheral oxygen saturation is less than 95% for 30 seconds and other causes have been excluded). Oxygen may be supplied by other devices if the oxygen concentration is sufficient for the subjects in the study group. The oxygen saturation and respiratory rate will be measured at the resting state every day during the treatment, namely after the end of daily treatment and 30 minutes after the inhalation of oxygen and hydrogen/oxygen.
|Study Type :||Interventional|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-center, Randomized, Parallel-Controlled Clinical Trial of the Application of A Hydrogen-Oxygen Generator With Nebulizer in the Improvement of Symptoms in Patients Infected With COVID-19|
|Actual Study Start Date :||February 15, 2020|
|Actual Primary Completion Date :||February 21, 2020|
|Estimated Study Completion Date :||August 1, 2020|
conventional treatment + hydrogen/ oxygen inhaled
Hydrogen-Oxygen Generator with Nebulizer Model: AMS-H-03 Gas production: 2.0 L/min, 2.5 L/min, and 3 L/min, three gears in total (in this study, the gas production of each machine is 3 L/min, two sets are connected and used together by three-way connection, and the total gas production is 6 L/min.) Manufacturer: Shanghai Asclepius Meditech Co., Ltd.
Other Name: Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 6 hour a day.
conventional treatment + oxygen inhaled
oxygen inhaled,3 L/min . 6 hour a day.
- Recovery time [ Time Frame: The day from the patient's admission to the Disease Progression to critical type，up to 2 weeks. ]The time from the patient's admission to the Disease Progression to critical type，up to 2 weeks.
- Clinical Symptom Remission time [ Time Frame: The day from admission to clinical remission,up to 2 weeks. ]Clinical Symptom Remission was defined as: The patient's body temperature was normal for more than 72 hours (without taking antipyretics or hormones) and had no conscious dyspnea or decreased dyspnea.
- fever duration [ Time Frame: The day from the patient's body temperature was abnormal to normal,up to 2 weeks. ]fever duration is the time during the patient's body temperature was abnormal。
- Leicester cough questionaire (LCQ) [ Time Frame: The day from admission to clinical remission,up to 2 weeks. ]The scale consisted of 19 questions in three domains: physical, psychological and social, each with a score ranging from 1.7. Each item represented an adverse event caused by a cough. The answer was scored on a Likert 7 point scale. The higher the score, the better the health condition. The total score ranged from 7 to 21.
- minimum oxygen [ Time Frame: The day from admission to clinical remission,up to 2 weeks. ]The minimum oxygen absorption flow with 95% oxygen saturation.
- Negative conversion rate [ Time Frame: the first day to the 14th days. ]Negative conversion rate of novel coronavirus nucleic acid in respiratory tract specimens 14 days after enrollment.
- white blood cell(WBC) [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]White blood cell (WBC) is a colorless, spherical and nucleated blood cell. The total number of normal adults is (4.0-10.0) x 109 / L, which can be changed in a certain range due to different time of day and the functional state of the body.
- Red blood cells(RBC) [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]also known as red blood cells, are often abbreviated into RBC in Chinese and English in routine tests. They are the most numerous blood cells in the blood, and also the most important medium for transporting oxygen through the blood in vertebrates. At the same time, they also have immune functions.
- Hemoglobin(Hb ) [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]The abbreviation of hemoglobin is HGB or Hb. Hemoglobin is a special protein that transports oxygen in red blood cells. It makes the blood red. It is composed of globin and heme. Its globin part is a tetramer composed of two different pairs of globin chains (α chain and β chain).
- Platelets(PLT) [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]Platelets are small pieces of cytoplasm released from the cytoplasm of mature megakaryocytes in bone marrow. Although megakaryocytes are the least in the hematopoietic cells of bone marrow, accounting for only 0.05% of the total number of bone marrow nucleated cells, the platelets produced by megakaryocytes are very important for the hemostatic function of the body.
- Lymphocyte count [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]Lymphocyte count refers to count and calculate the percentage of different types of white blood cells.
- The percentage of lymphocyte [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]Lymphocyte has the function of producing and carrying antibody and preventing virus infection. The percentage of lymphocyte was determined by routine blood test, and the normal value was 20.0% - 40.0%. The percentage of lymphocyte increased mainly in infectious diseases and decreased mainly in immune deficiency diseases.
- neutrophils [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]The membrane of neutrophils can release an unsaturated fatty acid, arachidonic acid. Under the action of enzyme, arachidonic acid can further generate a group of paracrine hormone substances, such as thromboxane and prostaglandin, which play an obvious role in regulating the caliber and permeability of blood vessels, can also cause inflammation and pain, and affect blood coagulation.
- C-reactive protein (CRP) [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]C-reactive protein (CRP) is a kind of protein (acute protein) which rises sharply in the plasma when the body is infected or damaged by tissue. It can activate the complement and strengthen the phagocytosis of phagocytes, so as to play a role in regulating. It can clear away the pathogenic microorganism and the damaged, necrotic and apoptotic tissue cells.
- Myocardial enzyme [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]Myocardial enzyme is a general term for many enzymes existing in the heart, including aspartate aminotransferase (AST), lactate dehydrogenase (LD or LDH), creatine kinase (CK) and isoenzyme, a-hydroxybutyrate dehydrogenase (a-hbd), etc. during acute myocardial infarction, a variety of enzymes in the heart are released due to the necrosis of myocardial cells, so the determination of serum central muscle enzyme is useful for the diagnosis and evaluation of myocardial infarction There is a certain value in the effect of supposition
- liver function [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]The purpose of liver function examination is to detect the liver disease, the degree of liver damage, the cause of liver disease, the prognosis and the cause of jaundice. At present, there are many kinds of clinical trials of liver function, no less than dozens. But each kind of liver function test can only detect a certain function of a certain aspect of the liver, so far, there is still no one test that can reflect all the functions of the liver.
- Renal function [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]Renal function refers to the function of the kidney to excrete the body's metabolic waste, maintain the stability of electrolytes such as sodium, potassium, calcium and acid-base balance. Renal function examination includes blood creatinine, blood urea nitrogen, blood and urine β 2-microglobulin, urinary albumin, urinary immunoglobulin G, urinary secretory immunoglobulin A, etc.
- Muscle enzyme [ Time Frame: The day of admission and clinical remission,up to 2 weeks. ]Muscle enzyme generally refers to: phosphocreatine kinase and creatine kinase isoenzyme examination, and some glutamic oxaloacetate transaminase. It is mainly used to check common muscle diseases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336462
|Contact: Zhang Ze Guang, email@example.com|
|Contact: Xin Yong Lin, firstname.lastname@example.org|