Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (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.
Conditions:
🦠 COVID-19
🗓️ Study Start (Actual) 6 June 2023
🗓️ Primary Completion (Estimated) May 2025
✅ Study Completion (Estimated) May 2026
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Columbus, Ohio, United States

📋 Eligibility Criteria

Description

  • 1. The subject or their authorized representative must be able to understand and provide informed consent
  • 2. Adult patients (≥18 years)
  • 3. Laboratory-confirmed SARS-CoV-2 infection within the 10 days prior to randomization
  • 4. Admitted to OSU East or OSU Main for acute respiratory failure (on at least 4 LPM oxygen)
  • 5. C-reactive protein (CRP) \> 32 mg/l
  • 6. Adequate i.v. access available (either peripheral or central venous access)
  • 7. Female subjects of childbearing potential must have a negative pregnancy test upon study entry

Exclusion Criteria:

  • 1. 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
  • 2. Individuals being treated with extracorporeal membrane oxygenation (ECMO)
  • 3. Subjects who, in the clinicians estimation, will be unlikely to survive the protocol duration due to imminent and unavoidable risk of death
  • 4. Individuals with hypertonia of the parasympathetic nervous system
  • 5. Prisoners
  • 6. Children (\<18 years)
  • 7. Women who may be pregnant, are pregnant, or have plans to become pregnant
  • 8. Women who are breast feeding
  • 9. Individuals with a known allergy to citicoline
  • 10. Subjects that are taking medications that contain L-Dopa, centrophenoxine, or meclofenoxate
  • 11. 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 April 2023
  • First Submitted that Met QC Criteria 19 May 2023
  • First Posted 31 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 October 2023
  • Last Update Posted 25 October 2023
  • Last Verified October 2023