Rehabilitation Treatment of Dysfunctions in Discharged Patients Who Are Previously Hospitalized due to 2019 Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Test group: The test group will use experimental medical equipment, Such as Hydrogen-Oxygen Generator with Nebulizer ( Shanghai Asclepius Meditec Co., Ltd.) + basic treatment (The researcher will giv
control group:basic treatment (The researcher will give the corresponding symptomatic support treatment according to the condition of the subjects)
Sponsors
Zhongshan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Male and female subjects aged between 18 and 75 years old (inclusive); 2)Subjects previously hospitalized due to COVID-19, who are recovered and discharged with negative results for COVID-19 and released from quarantine; 3)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); 4)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); 5)Subjects who are willing to participate and provided written informed consent form.
Exclusion criteria
Exclusion criteria: 1)Subjects with known malignant tumor; 2)Subjects with known moderate or severe pulmonary infection; 3)Subjects with mucosa injury in upper respiratory tract, for whom no inhalation treatment can be provided; 4)Subjects who are intolerable to inhalation treatment; 5)Subjects with moderate or severe disabilities; 6)Subjects with mental disorders or cognitive impairment who are unable to provide consent; 7)Subjects with neurological disease accompanied with sleep disorders for which medical intervention is provided before the diagnosis of COVID-19. 8)Subjects with any immunodeficiency (for example, subjects requiring chronic treatment with any corticosteroid or other immunosuppressants) judged by the investigator; 9)Allergy to any component of the investigational product that have contact with human body; 10)Complicate severe cardiac, hepatic or renal insufficiency; 11)Expected life expectancy < 1 year; 12)Subjects who are participating in any other clinical study of any investigational drug or medical device; 13)Pregnant or lactating women, or women who plan to become pregnant within the following one year; 14)Any other condition judged as inappropriate to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Borg score from baseline at 3 months after the study treatment.;Changes in PSQI score from baseline at 3 months after the study treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function evaluation;Change in imaging evaluation;Neurological and psychological function indicators;Inflammatory indicators;Usability evaluation of the medical device; | — |
Countries
China
Contacts
Public ContactYuanlin Song
Outcome results
None listed