Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-28 @ 6:01 AM
Study NCT ID:
NCT05881135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2023-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCARLET
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: