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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT05386420
Eligibility Criteria:
Inclusion Criteria:
1. Participants who have a positive SARS-CoV-2 test result ;
2. Participants who have been diagnosed with mild or ordinary type of COVID-19 infection;
3. Participants whose serum hyaluronic acid level was higher than the upper limit of normal value;
4. Participants who must agree to adhere to contraception restrictions;
5. Participants who understand and agree to comply with planned study procedures;
6. Participants who give signed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
1. Participants who have any of the following conditions when screening:
1. ALT or AST \> 5 ULN;
2. Scr \> 1.5 ULN or Ccr \< 50 mL/min;
3. TBIL \> 2ULN ;
4. HGB ≤ 90 g/ L;
5. PLT ≤ 75×10\^9/ L;
2. Participants who have suspected/active infections during the screening period including uncontrolled active bacterial, viral or fungal infections that require systemic treatment, except COVID-19 virus infections;
3. Participants who have any active autoimmune diseases during the screening period and need to be treated with immunosuppressants, including biological agents;
4. Participants who have a medical history of organ transplantation, or plan for organ transplantation including liver transplantation;
5. Participants who need a loading dose of anti-platelet drugs, such as aspirin (\>300 mg/day) and clopidogrel (\>300 mg/day);
6. Participants who have a medical history of central nervous system and digestive system bleeding, or a tendency of gastrointestinal bleeding, local active ulcer lesions included, in the last three months;
7. Participants who have biliary obstruction;
8. Female participants who are pregnant or breast-feeding or plan to be pregnant within this study period;
9. Male participants whose wife or partner plan to be pregnant within this study period.
10. Participants who have taken the drugs containing coumarin compounds, such as warfarin, within 3 days before screening;
11. Participants who have other diseases requiring hospitalization and/or in a need of surgical treatment within 7 days before screening, or have suffered from life-threatening diseases within 30 days before screening;
12. Participants who have known allergies to any of the components used in the formulation of the interventions;
13. Participants who have taken a part in a clinical study of an investigational intervention in the last 28 days. After 5 half-lives or 28 days, whichever is longer, can be allowed for screening;
14. Participants who are not suitable for this trial, and with any medical condition will compromise their own safety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05386420
Study Brief:
Protocol Section:
NCT05386420