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Citicoline for Coronavirus-related Lung Injury (SCARLET Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (≥18 years)

Admitted to OSU East or OSU Main for acute respiratory failure (on at least 4 LPM oxygen)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until hospital discharge or up to 29 days

Awards & highlights

SCARLET Trial Summary

This trial aims to find if a drug (citicoline) is safe and effective in adults with SARS CoV-2 infection and breathing trouble, compared to a placebo. Patients will receive the drug or placebo twice daily for 5 days.

Who is the study for?

Adults with confirmed COVID-19 and acute respiratory failure needing oxygen therapy can join this trial. They must understand the study, not be pregnant or breastfeeding, have no allergies to citicoline, and not take certain medications like L-Dopa. Critically ill patients likely to die soon or on ECMO are excluded.Check my eligibility

What is being tested?

The SCARLET trial is testing if i.v. citicoline helps adults with severe COVID-19 breathe better compared to a saline placebo. It's double-blinded (neither doctors nor patients know who gets what), randomized (assigned by chance), and checks for safety and improvement in oxygen levels.See study design

What are the potential side effects?

Potential side effects of citicoline may include changes in blood pressure, headache, nausea, blurred vision, chest pains or allergic reactions but specific side effects will be monitored given that it's being tested in a new patient population.

SCARLET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am admitted to OSU for severe breathing problems needing at least 4 LPM of oxygen.

SCARLET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until hospital discharge or up to 29 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until hospital discharge or up to 29 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and until hospital discharge or up to 29 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Citicoline's effect on acute hypoxemic respiratory failure in COVID-19 patients.

Safety of citicoline over a range of doses in COVID-19 patients presenting with acute hypoxemic respiratory failure.

Secondary outcome measures

Effect of citicoline on COVID specific disease severity scale in patients with acute COVID associated hypoxemic respiratory failure.

Effect of citicoline on Sequential Organ Failure Score (SOFA) in patients with COVID associated acute respiratory failure.

Side effects data

From 2016 Phase 4 trial • 62 Patients • NCT02074735

17%

Drowsiness

14%

Dry mouth

14%

Nausea

10%

Diarrhea

Headache

Bruising

Increased energy

Hypertension

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Citicoline

Placebo

SCARLET Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: IV 5 mg/kg/day CiticolineExperimental Treatment1 Intervention

i.v. bolus of 10 ml normal saline containing 5 mg/kg citicoline, administered twice daily for 5 days.

Group II: IV 10 mg/kg/day CiticolineExperimental Treatment1 Intervention

i.v. bolus of 10 ml normal saline containing 10 mg/kg citicoline, administered twice daily for 5 days.

Group III: IV 1 mg/kg/day CiticolineExperimental Treatment1 Intervention

i.v. bolus of 10 ml normal saline containing citicoline 1 mg/kg, administered twice daily for 5 days.

Group IV: IV 10 ml normal salinePlacebo Group1 Intervention

i.v. bolus of 10 ml normal saline (without active ingredient) administered i.v., twice daily for 5 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Citicoline

2010

Completed Phase 4

~780

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,540 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this clinical experiment?

"Affirmative. Information available on clinicaltrials.gov indicates that this research trial, which was first published on June 6th 2023, is actively searching for participants. Eighty individuals are needed to partake at a single medical centre."

Answered by AI

Is the enrollment period for this clinical trial still open?

"That is correct. According to clinicaltrials.gov, this medical research project was initially posted on June 6th 2023 and has been seeking new participants ever since. 80 patients are needed for the trial which will take place at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Elliott Crouser 2023. "Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial (SCARLET)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05881135.

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