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Studies

Interventional Active not recruiting Phase 1/Phase 2

NCT05881135 on ClinicalTrials.gov

Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)

  • Sponsor: The Ohio State University
  • Enrollment: 80 (Estimated)
  • Study start: 2023-06-06 (Actual)
  • Primary completion: 2025-03-17 (Actual)
  • Study completion: 2026-04-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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.

Conditions

  • COVID-19

Intervention / Treatment

  • Drug: Citicoline
  • Drug: Saline/Placebo

Primary Outcome Measures

  • Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure. (Until hospital discharge or up to 29 days)
    Safety will be assessed in each arm of the study: 1, 5, or 10 mg/kg/day citicoline by i.v. bolus or i.v. saline bolus for 5 consecutive days. Safety analysis will be performed based on a continuous safety monitoring rule to guide accrual suspension decisions based on number of treatment-related adverse events as assessed by the CTCAE v.5.0. The number of patients with an SAE that would warrant temporary suspension of accrual in a given group corresponds to a high posterior probability that the true SAE probability is greater than an acceptable level (i.e., Pr(pi \> 0.25 \| data) \> 0.85), where the posterior probability is determined from a Beta-Binomial distribution with Beta (1, 1) as the prior on pi.
  • Citicoline's effect on acute hypoxemic respiratory failure in COVID-19 patients. (Day 3)
    The primary clinical outcome will be measured on Day 3: lowest recorded SpO2/FiO2 ratio.

Countries

United States

Locations and Investigators

  • The Ohio State Wexner Medical Center, Columbus, United States