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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT05226767
Eligibility Criteria:
Inclusion Criteria:
1. Men and Women aged 18 (inclusive) and above.
2. Confirmed SARS-CoV-2 infection by RT-PCR If confirmed \>5 days before the randomization, another test will be taken on day 1.
3. Hospitalized COVID-19 patient in stable moderate condition to upper scale of severe condition (i.e., not requiring full respiratory assessment).
4. Oxygenation \< 96% on room air.
5. Subjects must be under observation or admitted to a controlled facility or hospital due to lung infection / respiratory infection only (home quarantine is not sufficient).
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Exclusion Criteria:
1. Tube feeding or parenteral nutrition.
2. Respiratory decompensation requiring mechanical ventilation.
3. Pregnant or lactating women.
4. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints (for examples social condition other non-related medical illness).
5. Known to have severe allergic reactions to one of the study drug components.
6. Active tuberculosis (TB) infection.
7. Subjects diagnosed to suffer from concomitant active infection: bacterial, fungal, viral, or other infection cause besides COVID-19.
8. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24-36 hours, irrespective of the provision of treatments.
9. Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months (steroids are permitted).
10. Participating in other drug clinical trial.
11. Estimated glomerular filtration rate (eGFR) \< 30 mL/min (including patients receiving hemodialysis or hemofiltration).
12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges).
13. Absolute neutrophil count (ANC) \< 1000/uL at screening.
14. Platelet count \< 50,000/uL at screening.
15. Body weight \< 40 kg or \>120 kg.
16. Treatment with other investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05226767
Study Brief:
Protocol Section:
NCT05226767