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:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT05075304
Eligibility Criteria:
Inclusion Criteria:
* 18≤ age ≤60, 18 kg/m2 ≤BMI ≤28 kg/m2, male or female;
* Diagnosed with 2019-nCoV infection and classified clinically as mild or general;
* Agreed not to participate in other clinical studies before completing this study;
* With the subject's consent and signed informed consent form by the subject or his/her legal representative.
Exclusion Criteria:
* Diagnosed with 2019-nCoV infection and classified clinically as severe or critical severe; severe pneumonia or acute respiratory distress syndrome, sepsis and septic shock;
* The disease would deteriorate significantly within 48 hours judged by the investigators;
* Immunodeficiency or immune related diseases not suitable for participation judged by the investigators (such as autoimmune diseases, IgG4 related diseases, allergic alveolitis, vasculitis, etc);
* Lymphocyte count \<0.5×109/L;
* Neutropenia history (neutrophil absolute count was less than 2×109/L in adults), except for infection;
* D- dimer \>2000 µg/L;
* Severe history of lung diseases, such as chronic obstructive pulmonary disease, lung cancer, tuberculosis, etc., history of heart disease: unstable angina pectoris, myocardial infarction, cardiac surgery, cardiac function≥ grade 3 (NYHA classification), serious history of liver disease (such as Child Pugh score ≥grade C), serious renal disease history, such as renal insufficiency (GFR ≤ 15ml/min/1.73m2), etc;
* The subjects used the following drugs within 2 weeks (including 2 weeks) before screening:
1. Calcineurin inhibitors (such as cyclosporin and tacrolimus);
2. Proliferation inhibitors (such as everolimus, sirolimus, etc);
3. anti-metabolic agents (such as mycophenolate mofetil, mycophenolic acid, purine sulfate, etc);
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05075304
Study Brief:
Protocol Section:
NCT05075304