NCT05881135 (SCARLET) is a Phase 1, PHASE2 clinical trial of Citicoline in COVID-19, sponsored by Ohio State University.

Who is sponsoring NCT05881135?

NCT05881135 is sponsored by Ohio State University.

What drugs are being tested in NCT05881135?

Interventions in NCT05881135: Citicoline, Saline/Placebo.

Is NCT05881135 still recruiting?

NCT05881135 is currently active, enrolled. Last updated 2 April 2025.

Last reviewed 2025-04-02 · How we verify

NCT05881135: SCARLET

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 1, PHASE2 Last updated 2 April 2025

What this trial tests

Phase 1, PHASE2 trial testing Citicoline in COVID-19 in 80 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 June 2023

Primary endpoint
17 March 2025

1 April 2026

Quick facts

Lead sponsor	Ohio State University
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	6 June 2023
Primary completion	17 March 2025
Estimated completion	1 April 2026
Sites	1 location across United States

Drugs / interventions tested

Citicoline (CITICOLINE) — full drug profile →
Saline/Placebo — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Ohio State University

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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
Pannu S, Exline MC, Bednash JS, Englert JA, et al · · 2024 · cited 1× · PMID 38760804 · DOI 10.1186/s13063-024-08155-0

Verify or expand the search:

Other trials of Citicoline

Trials testing the same drug.

NCT07089238 — Evaluate the Effects of Citicoline on Mood in Healthy Adults · NA · recruiting
NCT03949049 — Citicoline as Neuroprotector in Neonates Exposed to Hypoxia · Phase 3 · recruiting
NCT04003090 — Citicoline Concentration in Human Vitreous · NA · completed
NCT03758118 — Citicoline in Non-Arteritic Ischemic Optic Neuropathy · NA · completed
NCT05527106 — Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma · NA · completed

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Ohio State University trials

Trials by the same sponsor.

NCT06542458 — Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog · not yet recruiting
NCT07217548 — Solving Stigma Through POV Simulation: Enhancing Pharmacist Empathy-based Practices With Sickle Cell Disease Patients · NA · enrolling by invitation
NCT07215221 — Implementation of TBI-RECOVER in Substance Use Treatment · NA · not yet recruiting
NCT07278427 — Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START · recruiting
NCT07490444 — Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05881135 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ohio State University
Last refreshed: 2 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05881135.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing