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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Citicoline
    i.v. bolus administration every 12 hours for 5 days.
    Other names:
    • Somazina, CDP-choline
Experimental
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.
  • Drug: Citicoline
    i.v. bolus administration every 12 hours for 5 days.
    Other names:
    • Somazina, CDP-choline
Experimental
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.
  • Drug: Citicoline
    i.v. bolus administration every 12 hours for 5 days.
    Other names:
    • Somazina, CDP-choline
Placebo Comparator
IV 10 ml normal saline 		i.v. bolus of 10 ml normal saline (without active ingredient) administered i.v., twice daily for 5 days.
  • Drug: Saline/Placebo
    i.v. administered every 12 hours as a 10 ml bolus for 5 days.
    Other names:
    • Normal saline solution

Recruiting Locations

The Ohio State Wexner Medical Center
Columbus, Ohio 43210
Contact:
Elliott Crouser, MD
614-293-4925
Elliott.Crouser@osumc.edu

More Details

NCT ID
NCT05881135
Status
Recruiting
Sponsor
Ohio State University

Study Contact

Elliott Crouser, MD
6142934925
Elliott.Crouser@osumc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.