Evaluation of the Effects of Baricitinib in Patients with Acute Respiratory Distress Syndrome: A Pilot, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Introduction: Despite advances in supportive care, acute respiratory distress syndrome (ARDS) remains a major cause of mortality and morbidity in critically ill patients. The lack of effective pharmacological treatments underscores the necessity for novel, evidence-based therapies. Investigating baricitinib’s potential to improve outcomes could address unmet needs and transform management strategies in this serious condition. Material and methods: This double-blind, placebo-controlled clinical trial enrolled 20 patients with ARDS at Imam Reza Hospital, Tabriz, using convenience sampling. Participants were randomly assigned to two groups and received either baricitinib or a placebo. All patients received standard supportive care throughout hospitalization. Demographic and clinical data were collected from medical records and bedside interviews. Outcomes were assessed over 28 and 60 days, with both clinical and laboratory markers. Results: Significant differences were observed in arterial oxygenation (SpO₂/FiO₂, P=0.009), and reduced need for advanced respiratory support (P<0.05) for the intervention group. Although hospital stay was longer (P<0.05), ICU mortality was lower in the intervention group (P<0.05). Kaplan-Meier analysis revealed a higher survival probability with baricitinib, with mortality rates of 30% for baricitinib versus 50% in the control group. Conclusion: The findings of this study demonstrate that baricitinib administration in patients with ARDS led to significant improvements in oxygenation, reduced need for advanced respiratory support, and lower ICU mortality compared to the control group, despite a longer hospital stay.

Keywords: Baricitinib, Acute Respiratory Syndrome, Mortality, ICU