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A Prospective, Multi-center, Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Hydrogen-Oxygen Generator with Nebulizer for Adjuvant Treatment of 2019 Novel Coronavirus Pneumonia (COVID-19) Positive Patients

A Prospective, Multi-center, Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Hydrogen-Oxygen Generator with Nebulizer for Adjuvant Treatment of 2019 Novel Coronavirus Pneumonia (COVID-19) Positive Patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060113
Enrollment
Unknown
Registered
2022-05-19
Start date
2022-05-12
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Control group:Conventional oxygen supply equipment in the hospital (wall oxygen or cylinder oxygen) + basic treatment
Experimental group:Use experimental medical instruments and oxygen-hydrogen atomizing machine (Shanghai Asclepius Meditec Co., Ltd.) + basic treatment (researchers give corresponding symptomatic suppo

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. No gender limit, patients aged between 18 and 80 years (inclusive); 2. Diagnosed as general type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 9); 3. Patients who are willing to participate and provided written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects in the treatment or active stage of malignant tumor; 2. Subjects with known intolerance to inhalation therapy; 3. Subjects with known mental abnormality or cognitive impairment that prevents informed consent; 4. Subjects with immune dysfunction, long-term use of corticosteroids or other immunosuppressants; 5. Subjects with severe heart, liver and kidney dysfunction or serious primary diseases of the system; Acute exacerbation of chronic obstructive pulmonary disease; Acute attack of bronchial asthma; 6. Non-expectorant antioxidant drugs, including large doses of vitamin C and vitamin E; 7. Subjects participating in clinical trials of other drugs or devices; 8. Pregnant or lactating subjects; 9. Other conditions assessed by the investigator as unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Time to negative viral nucleic acid detection from the start of the study treatment;

Secondary

MeasureTime frame
Negative rate based on viral nucleic acid detection;Imaging evalution indicators;Clinical effectiveness within 7 days;Recovery rate and time to recovery of main symptoms;Oxygen saturation;

Countries

China

Contacts

Public ContactQu Jieming, Li Qingyun

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

liqingyun68@163.com+86 13501738686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026