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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT05770206
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects aged between 18 and 75 years old (inclusive).
2. Diagnosed with mild, moderate or severe type of COVID-19 according to the criteria of Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (Trial Version 10).
3. Positive result for COVID-19 nucleic acid test or rapid antigen detection at screening visit;
4. Presenting with at least one respiratory symptom (e.g. dyspnoea, shortness of breath) at hospital admission.
5. Be willing to participate in this trial and provide written informed consent form.
Exclusion Criteria:
1. Subjects with critical or asymptomatic type of COVID-19;
2. Subjects with any known malignant tumor or life expectancy less than half a year.
3. Subjects who are intolerable to inhalation treatment.
4. Subjects with mental disorders or cognitive impairment who are unable to provide consent.
5. Subjects with any immunodeficiency requiring chronic treatment with any corticosteroid or other immunosuppressants.
6. Complicate with any serious cardiac, hepatic or renal disease (as indicated by aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] ≥ 2 × upper limit of normal \[ULN\], or creatinine ≥ 176.8mmol/L, or New York Heart Association (NYHA) Classification for heart failure of Class IV) or any serious primary systematic disease.
7. Subjects who are going to use any non-expectorant antioxidant drug, including large doses of vitamin C and vitamin E during the study period.
8. Subjects who are participating in any other clinical study on any investigational drug or medical device.
9. Pregnant or lactating women.
10. Subjects with 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:
NCT05770206
Study Brief:
Protocol Section:
NCT05770206