Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT05504460
Eligibility Criteria:
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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05504460
Study Brief:
Protocol Section:
NCT05504460