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

NCT05881135 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-02

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2025-03-17
Completion
2026-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881135 on ClinicalTrials.gov