What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral agents, immune-modulating drugs, and supportive therapies. Antiviral agents like remdesivir can cause side effects such as nausea, elevated liver enzymes, and potential kidney issues. Immune-modulating drugs, such as corticosteroids, may lead to hyperglycemia, increased risk of infections, and osteoporosis with long-term use. Treatments like fluvoxamine, which has shown some promise in reducing disease progression, can cause gastrointestinal disturbances and sleep issues. Colchicine, another anti-inflammatory, may result in diarrhea and gastrointestinal discomfort. While citicoline is being studied for its potential benefits in COVID-19, its known side effects in other contexts include headache, insomnia, and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, focusing on different mechanisms of action. Remdesivir, an antiviral drug, was the first to receive FDA approval for treating COVID-19. Additionally, monoclonal antibodies like bamlanivimab and casirivimab/imdevimab were granted emergency use authorization for their ability to neutralize the virus. Dexamethasone, a corticosteroid, has been widely used to reduce inflammation in severe cases. While citicoline, which enhances cellular energy production and reduces inflammation, is being studied, there are no specific FDA-approved treatments with this exact mechanism for COVID-19 as of now.

What other types of research exist?

Promising novel alternatives to Citicoline for Coronavirus patients include L-carnitine, which has shown potential benefits in improving oxygen saturation and reducing inflammatory markers in a pilot study. Additionally, while not yet recommended outside clinical trials, fluvoxamine has shown some preliminary benefits in reducing disease progression in adults, though more data is needed for pediatric use.

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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)

Must not have

Subjects that are taking medications that contain L-Dopa, centrophenoxine, or meclofenoxate

Women who may be pregnant, are pregnant, or have plans to become pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until hospital discharge or up to 29 days

Summary

This trial is testing if citicoline, given through a vein, is safe and helpful for adults with severe COVID-19 who have trouble breathing. The study aims to see if citicoline can improve oxygen levels and reduce illness severity. Patients will receive either citicoline or another treatment, and their oxygen levels will be monitored regularly.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication that contains L-Dopa, centrophenoxine, or meclofenoxate.

Select...

I am pregnant or planning to become pregnant.

Select...

I cannot or will not consent to participate in the study and have no one to consent for me.

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I am under 18 years old.

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I am currently receiving ECMO treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Increased energy

Bruising

Hypertension

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Citicoline

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 include antiviral medications, anti-inflammatory agents, and supportive therapies. Antiviral drugs, such as remdesivir, work by inhibiting viral replication, thereby reducing the viral load in the body. Anti-inflammatory treatments, like dexamethasone, help to mitigate the severe inflammatory response often seen in COVID-19, which can lead to complications such as acute respiratory distress syndrome (ARDS). Supportive therapies, including oxygen supplementation and mechanical ventilation, are crucial for maintaining adequate oxygenation in patients with severe respiratory symptoms. Treatments like citicoline, which enhance cellular energy production and reduce inflammation, are particularly important as they may improve overall cellular function and reduce the severity of lung injury, potentially leading to better patient outcomes.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.High-quality trials and pharmacological studies needed as translational evidence for the application of traditional Chinese medicine Lianhua Qingwen against COVID-19.Janus sword actions of chloroquine and hydroxychloroquine against COVID-19.