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

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.

Timeline

Start

2023-06-06

Primary completion

2025-03-17

Completion

2026-04-01

Publications

• Pannu S, Exline MC, Bednash JS, Englert JA, Diaz P, Bartlett A, Brock G, Wu Q, Davis IC, Crouser ED. 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. Trials. 2024 May 18;25(1):328. doi: 10.1186/s13063-024-08155-0.

Drugs

Indications