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

NCT ID: NCT05881135

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2026-04-01

Brief 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.

Detailed Description

SCARLET is a single center, double-blinded, placebo-controlled, and randomized Phase 1 trial of i.v. citicoline in adult patients of any sex, gender, age, or ethnicity who are present with acute hypoxemic respiratory failure due to SARS CoV-2 infection. The goals are safety over a range of doses based on the number of treatment related adverse events as assessed by CTCAE v.5, and demonstration of efficacy as reflected by SpO2/FiO2 measured at day 3 in hospitalized COVID infected patients with acute hypoxemic respiratory failure, as defined by requiring at least 4 liters nasal cannula oxygen supplementation to maintain the SpO2 above 90%. The trial will enroll 20 patients per dose for 3 citicoline doses (1, 5, and 10 mg/kg/day) along with 20 placebo-treated controls.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IV 1 mg/kg/day Citicoline

i.v. bolus of 10 ml normal saline containing citicoline 1 mg/kg, administered twice daily for 5 days.

Group Type: EXPERIMENTAL

Citicoline

Intervention Type: DRUG

i.v. bolus administration every 12 hours for 5 days.

IV 5 mg/kg/day Citicoline

i.v. bolus of 10 ml normal saline containing 5 mg/kg citicoline, administered twice daily for 5 days.

Group Type: EXPERIMENTAL

Citicoline

Intervention Type: DRUG

i.v. bolus administration every 12 hours for 5 days.

IV 10 mg/kg/day Citicoline

i.v. bolus of 10 ml normal saline containing 10 mg/kg citicoline, administered twice daily for 5 days.

Group Type: EXPERIMENTAL

Citicoline

Intervention Type: DRUG

i.v. bolus administration every 12 hours for 5 days.

IV 10 ml normal saline

i.v. bolus of 10 ml normal saline (without active ingredient) administered i.v., twice daily for 5 days.

Group Type: PLACEBO_COMPARATOR

Saline/Placebo

Intervention Type: DRUG

i.v. administered every 12 hours as a 10 ml bolus for 5 days.

Interventions

Citicoline

i.v. bolus administration every 12 hours for 5 days.

Intervention Type: DRUG

Saline/Placebo

i.v. administered every 12 hours as a 10 ml bolus for 5 days.

Intervention Type: DRUG

Other Intervention Names

Somazina, CDP-choline; Normal saline solution

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Elliott Crouser

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

References

Pannu S, Exline MC, Bednash JS, Englert JA, Diaz P, Bartlett A, Brock G, Wu Q, Davis IC, Crouser ED. SCARLET (Supplemental Citicoline Administration to Reduce Lung injury Efficacy Trial): study protocol for a single-site, double-blinded, placebo-controlled, and randomized Phase 1/2 trial of i.v. citicoline (CDP-choline) in hospitalized SARS CoV-2-infected patients with hypoxemic acute respiratory failure. Trials. 2024 May 18;25(1):328. doi: 10.1186/s13063-024-08155-0.

Reference Type: DERIVED

PMID: 38760804 (View on PubMed)

Other Identifiers

2022H0451

Identifier Type: -

Identifier Source: org_study_id