- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05881135
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET) (SCARLET)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Elliott Crouser, MD
- Phone Number: 6142934925
- Email: Elliott.Crouser@osumc.edu
Study Contact Backup
- Name: Sarah Karow
- Phone Number: 6146854164
- Email: sarah.karow@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State Wexner Medical Center
-
Contact:
- Elliott Crouser, MD
- Phone Number: 614-293-4925
- Email: Elliott.Crouser@osumc.edu
-
Contact:
- Matthew Exline, MD
- Phone Number: 6142934925
- Email: Matthew.Exline@osumc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
i.v.
bolus administration every 12 hours for 5 days.
Other Names:
|
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.
|
i.v.
bolus administration every 12 hours for 5 days.
Other Names:
|
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.
|
i.v.
bolus administration every 12 hours for 5 days.
Other Names:
|
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.
|
i.v.
administered every 12 hours as a 10 ml bolus for 5 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure.
Time Frame: Until hospital discharge or up to 29 days
|
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.
|
Until hospital discharge or up to 29 days
|
Citicoline's effect on acute hypoxemic respiratory failure in COVID-19 patients.
Time Frame: Day 3
|
The primary clinical outcome will be measured on Day 3: lowest recorded SpO2/FiO2 ratio.
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of citicoline on COVID specific disease severity scale in patients with acute COVID associated hypoxemic respiratory failure.
Time Frame: Through day 8
|
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.
|
Through day 8
|
Effect of citicoline on Sequential Organ Failure Score (SOFA) in patients with COVID associated acute respiratory failure.
Time Frame: Through day 8
|
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.
|
Through day 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022H0451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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