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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT05881135
Eligibility Criteria:
1. The subject or their authorized representative must be able to understand and provide informed consent
2. Adult patients (≥18 years)
3. Laboratory-confirmed SARS-CoV-2 infection within the 10 days prior to randomization
4. Admitted to OSU East or OSU Main for acute respiratory failure (on at least 4 LPM oxygen)
5. C-reactive protein (CRP) \> 32 mg/l
6. Adequate i.v. access available (either peripheral or central venous access)
7. Female subjects of childbearing potential must have a negative pregnancy test upon study entry
Exclusion Criteria:
1. Subjects who are unable or unwilling to give written informed consent or to comply with study protocol and who have no legal authorized representative available to give consent on their behalf
2. Individuals being treated with extracorporeal membrane oxygenation (ECMO)
3. Subjects who, in the clinicians estimation, will be unlikely to survive the protocol duration due to imminent and unavoidable risk of death
4. Individuals with hypertonia of the parasympathetic nervous system
5. Prisoners
6. Children (\<18 years)
7. Women who may be pregnant, are pregnant, or have plans to become pregnant
8. Women who are breast feeding
9. Individuals with a known allergy to citicoline
10. Subjects that are taking medications that contain L-Dopa, centrophenoxine, or meclofenoxate
11. Subjects with past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the principal investigator (PI), may pose additional risks from participation in the study or that may impact the quality or interpretation of the data obtained from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05881135
Study Brief:
Protocol Section:
NCT05881135