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.
Protocol Amendment History
2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-05-19; most recent amendment 2025-03-28.
Status change: Recruiting → Active, Not Recruiting2025-03-28
Status change: Not Yet Recruiting → Recruiting2023-10-23