Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881135
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-04-25
Brief Title:
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial SCARLET
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial SCARLET
Status:
RECRUITING
Status Verified Date:
2023-10
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 iv citicoline is safe and efficacious compared to iv salinecontrol 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 iv treatment with citicoline or saline twice daily for 5 consecutive days SpO2FiO2 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 iv treatment with citicoline or saline twice daily for 5 consecutive days SpO2FiO2 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 iv 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 v5 and demonstration of efficacy as reflected by SpO2FiO2 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 mgkgday along with 20 placebo-treated controls
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None