Hydrogen-Oxygen Generator With Nebulizer in the Improvement of Symptoms in Patients Infected With COVID-19

NCT04336462 | Unknown

• 1 other identifier: JT202002LZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 compared with the reference device of EverFlo Oxygen Concentrator (registration certificate No.: NMPA Registration Standard: 20162542389) manufactured by Respironics, Inc. US.

Conditions

COVID-19

Keywords

Hydrogen-Oxygen Generator with Neburlizer; COVID-19

Outcome Measures

Primary Outcomes (1)

• Recovery time

  The time from the patient's admission to the Disease Progression to critical type，up to 2 weeks.

  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

  The day from admission to clinical remission,up to 2 weeks.

• fever duration

  The day from the patient's body temperature was abnormal to normal,up to 2 weeks.

• Leicester cough questionaire (LCQ)

  The day from admission to clinical remission,up to 2 weeks.

• minimum oxygen

  The day from admission to clinical remission,up to 2 weeks.

• Negative conversion rate

  the first day to the 14th days.

Study Arms (2)

oxyhydrogen

EXPERIMENTAL

conventional treatment + hydrogen/ oxygen inhaled

Device: oxyhydrogen

oxygen

EXPERIMENTAL

conventional treatment + oxygen inhaled

Device: Oxygen

Interventions

oxyhydrogen DEVICE

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.

Also known as: Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 6 hour a day.

oxyhydrogen

Oxygen DEVICE

oxygen inhaled,3 L/min . 6 hour a day.

oxygen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Asclepius Meditec Inc.: lead
• Shanghai Public Health Clinical Center: collaborator
• Henan Provincial People's Hospital: collaborator
• Shenzhen Third People's Hospital: collaborator
• The First People's Hospital of Yunnan: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai 6th People's Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Links

• Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis

MeSH Terms

Conditions

COVID-19

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Central Study Contacts

Zhang Ze Guang, doctor

CONTACT

18928868242; zheng862080@139.com

Xin Yong Lin, master

CONTACT

13901754567; ceo@ascleway.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 7, 2020
• Study Start: February 15, 2020
• Primary Completion: February 21, 2020
• Study Completion: August 1, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

CN (1)