COVID-19COVID-19NCT04336462
Hydrogen-Oxygen Generator With Nebulizer in the Improvement of Symptoms in Patients Infected With COVID-19
A study testing oxyhydrogen and Oxygen in people with COVID-19, run by Shanghai Asclepius Meditec Inc. at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of Hydrogen-Oxygen Generator with Nebulizer (model AMS-H-03) developed by Shanghai Asclepius Meditech Co., Ltd. as an adjuvant therapy for the patients with COVID-19 infected pneumonia in improving the clinical symptoms and reducing the incidence of severe pneumonia, as… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- oxyhydrogen and Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2020to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects participating in this clinical study must meet all of the following criteria:
- According to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 5), under the premise of meeting the diagnostic criteria of moderate COVID-19, the subjects should meet one of the following three conditions:
- ① Respiratory rate (RR): ≥ 20 times/min;
- ② In the state of air absorption and rest, the peripheral oxygen saturation is lower than 95%;
- ③ Arterial partial pressure of oxygen (PaO2)/FiO2: ≤ 400 mmHg (1mmHg=0.133 kPa).
- ≥18 years old and ≤85 years old subjects with normal autonomous judgment, regardless of gender and region;
- Subjects voluntarily participate in the study and have signed the informed consent form.
Who cannot join
- Have other significant diseases other than COVID-19, that is, a disease that, according to the investigator's judgment, can cause the subject to be at risk due to participation in the study, or affect the study results and the ability of the subject to participate in the study.
- Women who are pregnant or breastfeeding or plan to be pregnant during the study.
- Subjects with one of the following respiratory diseases:
- Asthma: Based on the investigator's judgment, the subjects are currently diagnosed with asthma.
- Subjects with a long-term history of COPD and medication or imaging evidence of significant lung structural damage (e.g., giant pulmonary bullae).
- Other respiratory diseases: Subjects with other active pulmonry diseases, such as active tuberculosis, lung cancer, wet bronchiectasis (the high-resolution CT shows bronchiectasis, with yellow sputum every day), sarcoidosis, idiopathic interstitial pulmonary fibrosis (IPF), primary pulmonary arterial hypertension, and uncontrolled sleep apnea (the severity of the disease will affect the implementation of c)the study according to the investigator's judgment), complicated with pneumothorax, pleural effusion, pulmonary embolism, bronchial asthma, tumor, and fever of unknown origin, etc.
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- d)Lung volume reduction: Subjects received lung volume reduction, lobectomy, or bronchoscopic lung volume reduction (endobronchial occlusion, airway bypass, endobronchial valve, steam thermal ablation, biological sealant and airway implant) within 6 months.
- e)Subjects in critical or unstable conditions. Critical (meeting any of the following symptoms): 1. Respiratory failure occurs and mechanical ventilation is needed; 2. Shock occurs; 3. With other organ failure, ICU monitoring and treatment is needed.
- f)Risk factors for pneumonia: immunosuppressive diseases (HIV), severe neurological disease affecting upper respiratory tract control, or other risk factors that the investigator believes can cause a significant risk of pneumonia in subjects.
- Subjects with serious primary diseases of heart, liver, kidney, hematopoietic system and other important organs or systems.
- Subjects with mental disorder and cognitive impairment.
- Subjects who do not follow the study steps.
- Patients with doubts about the effectiveness of informed consent: Subjects with mental illness, mental retardation, poor motivation, drug abuse (including drugs and alcohol) or other disease history restricting the effectiveness of informed consent in this study.
- Use of non-expectorants and antioxidants, including large doses of vitamin C and vitamen E.
- Subjects who are not suitable for participation in this study in the judgment of investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Zheng Z Guang, doctor, 86-20-83062843, zheng862080@139.com
Hu J Ying, master, 13544425867, hujieyingjy@126.com
About this study
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
This study will evaluate the efficacy and safety of Hydrogen-Oxygen Generator with Nebulizer (model AMS-H-03) developed by Shanghai Asclepius Meditech Co., Ltd. as an adjuvant therapy for the patients with COVID-19 infected pneumonia in improving the clinical symptoms and reducing the incidence of severe pneumonia, as compared with the reference device of EverFlo Oxygen Concentrator (registration certificate No.: NMPA Registration Standard: 20162542389) manufactured by Respironics, Inc. US.
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- oxyhydrogen, Oxygen
- Keywords
- Hydrogen-Oxygen Generator with Neburlizer, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxyhydrogenDevice
Also called Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 6 hour a day.
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.
OxygenDevice
oxygen inhaled,3 L/min . 6 hour a day.
| Study group | Role | What they receive |
|---|---|---|
| oxyhydrogen | Experimental | conventional treatment + hydrogen/ oxygen inhaled Receives: Device: oxyhydrogen |
| oxygen | Experimental | conventional treatment + oxygen inhaled Receives: Device: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
The time from the patient's admission to the Disease Progression to critical type，up to 2 weeks.
Measured: The day from the patient's admission to the Disease Progression to critical type，up to 2 weeks.
Secondary outcomes (17)
Clinical Symptom Remission time
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.
Measured: The day from admission to clinical remission,up to 2 weeks.
fever duration
fever duration is the time during the patient's body temperature was abnormal。
Measured: The day from the patient's body temperature was abnormal to normal,up to 2 weeks.
Leicester cough questionaire (LCQ)
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.
Measured: The day from admission to clinical remission,up to 2 weeks.
minimum oxygen
The minimum oxygen absorption flow with 95% oxygen saturation.
Measured: The day from admission to clinical remission,up to 2 weeks.
Negative conversion rate
Negative conversion rate of novel coronavirus nucleic acid in respiratory tract specimens 14 days after enrollment.
Measured: the first day to the 14th days.
white blood cell(WBC)
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
Red blood cells(RBC)
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
Hemoglobin(Hb )
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).
Measured: The day of admission and clinical remission,up to 2 weeks.
Platelets(PLT)
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
Lymphocyte count
Lymphocyte count refers to count and calculate the percentage of different types of white blood cells.
Measured: The day of admission and clinical remission,up to 2 weeks.
The percentage of lymphocyte
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
neutrophils
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
C-reactive protein (CRP)
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
Myocardial enzyme
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
Measured: The day of admission and clinical remission,up to 2 weeks.
liver function
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
Renal function
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
Muscle enzyme
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.
Measured: The day of admission and clinical remission,up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start15 Feb 2020
- Primary completion21 Feb 2020
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Asclepius Meditec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Henan Provincial People's Hospital, Shenzhen Third People's Hospital, The First People's Hospital of Yunnan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Ze-guang Zheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336462
- Sponsor's protocol ID
- JT202002LZ
- Acronym
- COVID-19
- Status last verified
- Apr 2020
- First submitted
- 25 Mar 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04336462
- Acronym / sponsor ID
- COVID-19 / JT202002LZ
- Conditions
- COVID-19
- Keywords
- Hydrogen-Oxygen Generator with Neburlizer, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Asclepius Meditec Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, Henan Provincial People's Hospital, Shenzhen Third People's Hospital, The First People's Hospital of Yunnan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of Hydrogen-Oxygen Generator with Nebulizer (model AMS-H-03) developed by Shanghai Asclepius Meditech Co., Ltd. as an adjuvant therapy for the patients with COVID-19 infected pneumonia in improving the clinical symptoms and reducing the incidence of severe pneumonia, as compared with the reference device of EverFlo Oxygen Concentrator (registration certificate No.: NMPA Registration Standard: 20162542389) manufactured by Respironics, Inc. US.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxyhydrogen | Experimental | Device: oxyhydrogenconventional treatment + hydrogen/ oxygen inhaled |
| oxygen | Experimental | Device: Oxygenconventional treatment + oxygen inhaled |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects participating in this clinical study must meet all of the following criteria:
- According to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 5), under the premise of meeting the diagnostic criteria of moderate COVID-19, the subjects should meet one of the following three conditions:
- ① Respiratory rate (RR): ≥ 20 times/min;
- ② In the state of air absorption and rest, the peripheral oxygen saturation is lower than 95%;
- ③ Arterial partial pressure of oxygen (PaO2)/FiO2: ≤ 400 mmHg (1mmHg=0.133 kPa).
Key exclusion criteria (15 listed)
- Have other significant diseases other than COVID-19, that is, a disease that, according to the investigator's judgment, can cause the subject to be at risk due to participation in the study, or affect the study results and the ability of the subject to participate in the study.
- Women who are pregnant or breastfeeding or plan to be pregnant during the study.
- Subjects with one of the following respiratory diseases:
- Other respiratory diseases: Subjects with other active pulmonry diseases, such as active tuberculosis, lung cancer, wet bronchiectasis (the high-resolution CT shows bronchiectasis, with yellow sputum every day), sarcoidosis, idiopathic interstitial pulmonary fibrosis (IPF), primary pulmonary arterial hypertension, and uncontrolled sleep apnea (the severity of the disease will affect the implementation of c)the study according to the investigator's judgment), complicated with pneumothorax, pleural effusion, pulmonary embolism, bronchial asthma, tumor, and fever of unknown origin, etc.
- d)Lung volume reduction: Subjects received lung volume reduction, lobectomy, or bronchoscopic lung volume reduction (endobronchial occlusion, airway bypass, endobronchial valve, steam thermal ablation, biological sealant and airway implant) within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxyhydrogenAlso: Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 6 hour a day.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. | Device | oxyhydrogen |
| Oxygenoxygen inhaled,3 L/min . 6 hour a day. | Device | oxygen |
Primary outcome
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.
17 secondary outcomes
Clinical Symptom Remission time
Time frame: The day from admission to clinical remission,up to 2 weeks.
fever duration
Time frame: The day from the patient's body temperature was abnormal to normal,up to 2 weeks.
Leicester cough questionaire (LCQ)
Time frame: The day from admission to clinical remission,up to 2 weeks.
minimum oxygen
Time frame: The day from admission to clinical remission,up to 2 weeks.
Negative conversion rate
Time frame: the first day to the 14th days.
white blood cell(WBC)
Time frame: The day of admission and clinical remission,up to 2 weeks.
Red blood cells(RBC)
Time frame: The day of admission and clinical remission,up to 2 weeks.
Hemoglobin(Hb )
Time frame: The day of admission and clinical remission,up to 2 weeks.
Platelets(PLT)
Time frame: The day of admission and clinical remission,up to 2 weeks.
Lymphocyte count
Time frame: The day of admission and clinical remission,up to 2 weeks.
The percentage of lymphocyte
Time frame: The day of admission and clinical remission,up to 2 weeks.
neutrophils
Time frame: The day of admission and clinical remission,up to 2 weeks.
C-reactive protein (CRP)
Time frame: The day of admission and clinical remission,up to 2 weeks.
Myocardial enzyme
Time frame: The day of admission and clinical remission,up to 2 weeks.
liver function
Time frame: The day of admission and clinical remission,up to 2 weeks.
Renal function
Time frame: The day of admission and clinical remission,up to 2 weeks.
Muscle enzyme
Time frame: The day of admission and clinical remission,up to 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal StenosisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxyhydrogen and Oxygen in people with COVID-19, run by Shanghai Asclepius Meditec Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Ze Guang, doctor (18928868242, zheng862080@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: The day from the patient's admission to the Disease Progression to critical type，up to 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.