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Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
Sponsor: Ohio State University
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-06-06
Completion Date
2026-04-01
Last Updated
2025-04-02
Healthy Volunteers
No
Conditions
Interventions
Citicoline
i.v. bolus administration every 12 hours for 5 days.
Saline/Placebo
i.v. administered every 12 hours as a 10 ml bolus for 5 days.
Locations (1)
The Ohio State Wexner Medical Center
Columbus, Ohio, United States