Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET) (SCARLET)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
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.
Sites / Locations
- The Ohio State Wexner Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
IV 1 mg/kg/day Citicoline
IV 5 mg/kg/day Citicoline
IV 10 mg/kg/day Citicoline
IV 10 ml normal saline
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.