Evidence map›Paper›PMID 38760804›Full record

ArticleTrials2024

SCARLET (Supplemental Citicoline Administration to Reduce Lung injury Efficacy Trial): study protocol for a single-site, double-blinded, placebo-controlled, and randomized Phase 1/2 trial of i.v. citicoline (CDP-choline) in hospitalized SARS CoV-2-infected patients with hypoxemic acute respiratory failure.

Sonal Pannu, Matthew C Exline, Joseph S Bednash, Joshua A Englert, Philip Diaz, Amy Bartlett, Guy Brock, Qing Wu, Ian C Davis, Elliott D Crouser

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05881135 (Supplemental Citicoline Administration to Reduce Lung Injury Efficacy Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05881135 phase1 / phase2active not recruitingnot on this map

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

TypeinterventionalSponsorOhio State UniversityRan2023 to 2026Enrolled80ConditionsCOVID-19ArmsCiticoline, Saline/Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Sonal PannuDivision of Pulmonary, Critical Care and Sleep Medicine of the Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.
Matthew C ExlineDivision of Pulmonary, Critical Care and Sleep Medicine of the Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.
Joseph S BednashDivision of Pulmonary, Critical Care and Sleep Medicine of the Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.
Joshua A EnglertDivision of Pulmonary, Critical Care and Sleep Medicine of the Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.
Philip DiazDivision of Pulmonary, Critical Care and Sleep Medicine of the Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.
Amy BartlettCenter for Clinical and Translational Sciences, The Ohio State University, Columbus, OH, USA.
Guy BrockDepartment of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.
Qing WuDepartment of Biomedical Informatics, The Ohio State University, Columbus, OH, USA.
Ian C DavisDepartment of Veterinary Biosciences, The Ohio State University, Columbus, OH, USA. davis.2448@osu.edu.ORCID http://orcid.org/0000-0002-5308-4776
Elliott D CrouserDivision of Pulmonary, Critical Care and Sleep Medicine of the Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.

Funding

Supplemental Citicoline Administration for Reduction of Lung Injury Efficacy Trial (SCARLET)U01AI167784 · NIAID · OHIO STATE UNIVERSITY · PI CROUSER, ELLIOTT D, DAVIS, IAN CHRISTOPHER · 2022 to 2024
$1.6M
Foundation for the National Institutes of Health 1U01AI167784-01NIAID NIH HHS U01 AI167784
6 · The paper itself

Abstract

backgroundThe SARS CoV-2 pandemic has resulted in more than 1.1 million deaths in the USA alone. Therapeutic options for critically ill patients with COVID-19 are limited. Prior studies showed that post-infection treatment of influenza A virus-infected mice with the liponucleotide CDP-choline, which is an essential precursor for de novo phosphatidylcholine synthesis, improved gas exchange and reduced pulmonary inflammation without altering viral replication. In unpublished studies, we found that treatment of SARS CoV-2-infected K18-hACE2-transgenic mice with CDP-choline prevented development of hypoxemia. We hypothesize that administration of citicoline (the pharmaceutical form of CDP-choline) will be safe in hospitalized SARS CoV-2-infected patients with hypoxemic acute respiratory failure (HARF) and that we will obtain preliminary evidence of clinical benefit to support a larger Phase 3 trial using one or more citicoline doses.

methodsWe will conduct a single-site, double-blinded, placebo-controlled, and randomized Phase 1/2 dose-ranging and safety study of Somazina® citicoline solution for injection in consented adults of any sex, gender, age, or ethnicity hospitalized for SARS CoV-2-associated HARF. The trial is named "SCARLET" (Supplemental Citicoline Administration to Reduce Lung injury Efficacy Trial). We hypothesize that SCARLET will show that i.v. citicoline is safe at one or more of three doses (0.5, 2.5, or 5 mg/kg, every 12 h for 5 days) in hospitalized SARS CoV-2-infected patients with HARF (20 per dose) and provide preliminary evidence that i.v. citicoline improves pulmonary outcomes in this population. The primary efficacy outcome will be the S DISCUSSION: Citicoline has many characteristics that would be advantageous to any candidate COVID-19 therapeutic, including safety, low-cost, favorable chemical characteristics, and potentially pathogen-agnostic efficacy. Successful demonstration that citicoline is beneficial in severely ill patients with SARS CoV-2-induced HARF could transform management of severely ill COVID patients.

trial registrationThe trial was registered at www. CLINICALTRIALS: gov on 5/31/2023 (NCT05881135). TRIAL STATUS: Currently enrolling.

Indexed as

COVID-19Cytidine Diphosphate CholineRandomized Controlled Trials as TopicSARS-CoV-2Administration, IntravenousAdultClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicCOVID-19 Drug TreatmentDouble-Blind MethodFemaleHospitalizationHumansHypoxiaMalePandemicsCytidine Diphosphate CholineAcute respiratory failureCDP-cholineCiticolineCOVID-19HypoxemiaInfluenzaLungSARS CoV-2

Identifiers

PMID38760804
PMCPMC11102211

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.