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A multicenter, randomized, controlled trial for efficacy and safety of hydrogen inhalation in the treatment of novel coronavirus pneumonia (COVID-19) patients

A multicenter, randomized, controlled trial for efficacy and safety of hydrogen inhalation in the treatment of novel coronavirus pneumonia (COVID-19) patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030258
Enrollment
Unknown
Registered
2020-02-26
Start date
2020-02-21
Completion date
Unknown
Last updated
2020-03-02

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

Experimental group:Conventional drug therapy plus hydrogen inhalation
Control group:Conventional drug therapy

Sponsors

The Fourth Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Adults aged >=18 years understand and agree to sign informed consent; (2) a novel coronavirus infection confirmed by laboratory RT-PCR. (3) Hospitalized patients with fever (axillary temperature >=37.0 degree C) or respiratory symptoms; (4) The interval between symptom onset and immediate enrollment is within 14 days; (5) Those who did not participate in other clinical trials within 3 months; (6) No other antiviral drugs were involved in the follow-up study within 14 days.

Exclusion criteria

Exclusion criteria: (1) novel coronavirus pneumonia is a disease or condition beyond the pneumonia. That is, according to the researchers' judgement, the subjects will be at risk for taking part in the research, or will have an impact on the results of the study and the ability of the subjects to participate in the study; (2) A woman who is pregnant or breastfeeding or who plans to be pregnant during the study period; (3) Combined with heart, liver, kidney, hematopoietic system and other important organs or systems of serious primary diseases; (4) Severe and critical patients: respiratory distress, RR >=30 times / min; in resting state, oxygen saturation <= 93%; arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) < 300MMHG; respiratory failure, mechanical ventilation; shock; other organ failure requiring ICU monitoring and treatment; (5) Patients over 70 years old; (6) Patients with mental disorders and cognitive disorders; (7) Those who have poor compliance, are unwilling to participate in the project or do not sign the informed consent during their stay in the hospital. There are doubts about the validity of informed consent: subjects with mental illness, mental retardation, poor motivation, drug abuse (including drugs and alcohol) or other disease history restricting the validity of informed consent in this study; (8) Patients with glucocorticoid; (9) The researchers think it is not suitable to participate in this study.

Design outcomes

Secondary

MeasureTime frame
Antipyretic time;Pulmonary CT inflammatory absorption;Time of nucleic acid turning negative;Severe conversion rate;quality of life;anxiety;depression;IADL;basic ADL;

Primary

MeasureTime frame
temperature;respiratory rate;Blood oxygen saturation;Cough symptom;Lung CT;Fatality rate;

Countries

China

Contacts

Public ContactWei Yang

The Fourth Affiliated Hospital of Harbin Medical University

hydyangwei@tom.com+86 13845099775

Outcome results

None listed

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