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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 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 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05881135
The ClinicalTrials.gov registry entry for NCT05881135 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.