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NCT05881135 · ClinicalTrials.gov registry record · Phase 1
Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)
A Phase 1 study of COVID-19, sponsored by Ohio State University.
- Active
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05881135: Active Phase 1 study of COVID-19, sponsored by Ohio State University.
NCT05881135 is a Phase 1 study of COVID-19 that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 80 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05881135, a Phase 1 study of COVID-19, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 t
Conditions Studied
Interventions
- DRUG Citicoline
- DRUG Saline/Placebo
Study Locations (1)
Ohio
- The Ohio State Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
What the registry record for NCT05881135 still lists
NCT05881135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Citicoline is the first listed.
NCT05881135 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05881135 about?
NCT05881135 is a clinical study titled "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 ques...
What is the current status of trial NCT05881135?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2023-06-06. Estimated completion is 2026-04-01.
What conditions does trial NCT05881135 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT05881135?
The interventions under investigation include: Citicoline (DRUG), Saline/Placebo (DRUG).
Who is sponsoring clinical trial NCT05881135?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05881135 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05881135's enrollment target sits among peer trials
80 216th of 298 higher than 78 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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