COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05504460

Yuanlin Song, PhD

ylsong@163.com

2022-08-17

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: male and female subjects aged between 18 and 75 years old (inclusive); subjects previously hospitalized due to covid-19, who are recovered and discharged with negative results for covid-19 and released from quarantine; known symptoms of respiratory dysfunctions (such as dyspnea), and / or neurological/psychological dysfunction (such as sleep disorders, anxiety, and depression) and / or somatic dysfunction (such as fatigue); borg dyspnea or fatigue score before study treatment ≥ 1 (please refer to appendix 2: borg scale for specific information), and psqi score ≥ 2 (please refer to appendix 3: psqi scale for specific information); subjects who are willing to participate and provided written informed consent form.

subjects with known malignant tumor; subjects with known moderate or severe pulmonary infection; subjects with mucosa injury in upper respiratory tract, for whom no inhalation treatment can be provided; subjects who are intolerable to inhalation treatment; subjects with moderate or severe disabilities; subjects with mental disorders or cognitive impairment who are unable to provide consent; subjects with neurological disease accompanied with sleep disorders for which medical intervention is provided before the diagnosis of covid-19. subjects with any immunodeficiency (for example, subjects requiring chronic treatment with any corticosteroid or other immunosuppressants) judged by the investigator; allergy to any component of the investigational product that have contact with human body; complicate severe cardiac, hepatic or renal insufficiency; expected life expectancy < 1 year; subjects who are participating in any other clinical study of any investigational drug or medical device; pregnant or lactating women, or women who plan to become pregnant within the following one year; any other condition judged as inappropriate to participate in this study by the investigator.

2

Shanghai Zhongshan Hospital

18

75

China

Patients recovered from covid

N/A

216

Changes in Borg score index from baseline at 3 months after the start of the study treatment.;Changes in PSQI index from baseline at 3 months after the start of the study treatment.

None

Not reported

[{"arm_notes": "nan", "treatment_id": 605, "treatment_name": "Hydrogen-oxygen nebulizer", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]