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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Citicoline
Saline/Placebo
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The subject or their authorized representative must be able to understand and provide informed consent Adult patients (≥18 years) Laboratory-confirmed SARS-CoV-2 infection within the 10 days prior to randomization Admitted to OSU East or OSU Main for acute respiratory failure (on at least 4 LPM oxygen) C-reactive protein (CRP) > 32 mg/l Adequate i.v. access available (either peripheral or central venous access) Female subjects of childbearing potential must have a negative pregnancy test upon study entry Exclusion Criteria: 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 Individuals being treated with extracorporeal membrane oxygenation (ECMO) Subjects who, in the clinicians estimation, will be unlikely to survive the protocol duration due to imminent and unavoidable risk of death Individuals with hypertonia of the parasympathetic nervous system Prisoners Children (<18 years) Women who may be pregnant, are pregnant, or have plans to become pregnant Women who are breast feeding Individuals with a known allergy to citicoline Subjects that are taking medications that contain L-Dopa, centrophenoxine, or meclofenoxate 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.

Sites / Locations

  • The Ohio State Wexner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

IV 1 mg/kg/day Citicoline

IV 5 mg/kg/day Citicoline

IV 10 mg/kg/day Citicoline

IV 10 ml normal saline

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure.
Safety will be assessed in each arm of the study: 1, 5, or 10 mg/kg/day citicoline by i.v. bolus or i.v. saline bolus for 5 consecutive days. Safety analysis will be performed based on a continuous safety monitoring rule to guide accrual suspension decisions based on number of treatment-related adverse events as assessed by the CTCAE v.5.0. The number of patients with an SAE that would warrant temporary suspension of accrual in a given group corresponds to a high posterior probability that the true SAE probability is greater than an acceptable level (i.e., Pr(pi > 0.25 | data) > 0.85), where the posterior probability is determined from a Beta-Binomial distribution with Beta (1, 1) as the prior on pi.
Citicoline's effect on acute hypoxemic respiratory failure in COVID-19 patients.
The primary clinical outcome will be measured on Day 3: lowest recorded SpO2/FiO2 ratio.

Secondary Outcome Measures

Effect of citicoline on COVID specific disease severity scale in patients with acute COVID associated hypoxemic respiratory failure.
Days 1,3,5 and 8 COVID ordinal outcomes scale (COOS). The COOS scale ranges from 0-8 with higher scores corresponding with worse clinical outcomes.
Effect of citicoline on Sequential Organ Failure Score (SOFA) in patients with COVID associated acute respiratory failure.
Days 1,3,5, and 8 composite and component SOFA scores measure while the study subject is in the ICU. SOFA scores range from 0-24 with higher scores corresponding to more severe organ failures.

Full Information

First Posted
April 25, 2023
Last Updated
October 23, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05881135
Brief Title
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
Acronym
SCARLET
Official Title
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV 1 mg/kg/day Citicoline
Arm Type
Experimental
Arm Description
i.v. bolus of 10 ml normal saline containing citicoline 1 mg/kg, administered twice daily for 5 days.
Arm Title
IV 5 mg/kg/day Citicoline
Arm Type
Experimental
Arm Description
i.v. bolus of 10 ml normal saline containing 5 mg/kg citicoline, administered twice daily for 5 days.
Arm Title
IV 10 mg/kg/day Citicoline
Arm Type
Experimental
Arm Description
i.v. bolus of 10 ml normal saline containing 10 mg/kg citicoline, administered twice daily for 5 days.
Arm Title
IV 10 ml normal saline
Arm Type
Placebo Comparator
Arm Description
i.v. bolus of 10 ml normal saline (without active ingredient) administered i.v., twice daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
Citicoline
Other Intervention Name(s)
Somazina, CDP-choline
Intervention Description
i.v. bolus administration every 12 hours for 5 days.
Intervention Type
Drug
Intervention Name(s)
Saline/Placebo
Other Intervention Name(s)
Normal saline solution
Intervention Description
i.v. administered every 12 hours as a 10 ml bolus for 5 days.
Primary Outcome Measure Information:
Title
Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure.
Description
Safety will be assessed in each arm of the study: 1, 5, or 10 mg/kg/day citicoline by i.v. bolus or i.v. saline bolus for 5 consecutive days. Safety analysis will be performed based on a continuous safety monitoring rule to guide accrual suspension decisions based on number of treatment-related adverse events as assessed by the CTCAE v.5.0. The number of patients with an SAE that would warrant temporary suspension of accrual in a given group corresponds to a high posterior probability that the true SAE probability is greater than an acceptable level (i.e., Pr(pi > 0.25 | data) > 0.85), where the posterior probability is determined from a Beta-Binomial distribution with Beta (1, 1) as the prior on pi.
Time Frame
Until hospital discharge or up to 29 days
Title
Citicoline's effect on acute hypoxemic respiratory failure in COVID-19 patients.
Description
The primary clinical outcome will be measured on Day 3: lowest recorded SpO2/FiO2 ratio.
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Effect of citicoline on COVID specific disease severity scale in patients with acute COVID associated hypoxemic respiratory failure.
Description
Days 1,3,5 and 8 COVID ordinal outcomes scale (COOS). The COOS scale ranges from 0-8 with higher scores corresponding with worse clinical outcomes.
Time Frame
Through day 8
Title
Effect of citicoline on Sequential Organ Failure Score (SOFA) in patients with COVID associated acute respiratory failure.
Description
Days 1,3,5, and 8 composite and component SOFA scores measure while the study subject is in the ICU. SOFA scores range from 0-24 with higher scores corresponding to more severe organ failures.
Time Frame
Through day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The subject or their authorized representative must be able to understand and provide informed consent Adult patients (≥18 years) Laboratory-confirmed SARS-CoV-2 infection within the 10 days prior to randomization Admitted to OSU East or OSU Main for acute respiratory failure (on at least 4 LPM oxygen) C-reactive protein (CRP) > 32 mg/l Adequate i.v. access available (either peripheral or central venous access) Female subjects of childbearing potential must have a negative pregnancy test upon study entry Exclusion Criteria: 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 Individuals being treated with extracorporeal membrane oxygenation (ECMO) Subjects who, in the clinicians estimation, will be unlikely to survive the protocol duration due to imminent and unavoidable risk of death Individuals with hypertonia of the parasympathetic nervous system Prisoners Children (<18 years) Women who may be pregnant, are pregnant, or have plans to become pregnant Women who are breast feeding Individuals with a known allergy to citicoline Subjects that are taking medications that contain L-Dopa, centrophenoxine, or meclofenoxate 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elliott Crouser, MD
Phone
6142934925
Email
Elliott.Crouser@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Karow
Phone
6146854164
Email
sarah.karow@osumc.edu
Facility Information:
Facility Name
The Ohio State Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elliott Crouser, MD
Phone
614-293-4925
Email
Elliott.Crouser@osumc.edu
First Name & Middle Initial & Last Name & Degree
Matthew Exline, MD
Phone
6142934925
Email
Matthew.Exline@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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