Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this single center, double-blinded, placebo-controlled, and randomized Phase 1 trial is to determine if i.v. citicoline is safe and efficacious compared to i.v. saline/control in adults presenting with SARS CoV-2 infection complicated by acute hypoxemic respiratory failure. The main questions it aims to answer:

• Is citicoline safe in this patient population?

• Does citicoline have a benefit in terms of improving oxygenation?

• Does citicoline reduce overall severity of illness as reflected by standardized scales.

Patients will be assigned to i.v. treatment with citicoline or saline twice daily for 5 consecutive days. SpO2/FiO2 ratios will be recorded daily as per standard clinical practice to compare citicoline treatments at three different doses to placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Choline; Cytidine Diphosphate Choline

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.