Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05881135
PHASE1/PHASE2

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

Sponsor: Ohio State University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-06-06

Completion Date

2026-04-01

Last Updated

2025-04-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

Citicoline

i.v. bolus administration every 12 hours for 5 days.

DRUG

Saline/Placebo

i.v. administered every 12 hours as a 10 ml bolus for 5 days.

Locations (1)

The Ohio State Wexner Medical Center

Columbus, Ohio, United States