Baricitinib or imatinib in hospitalized COVID-19 patients: Results from COVINIB, an exploratory randomized clinical

Alejandro Morales-Ortega1,2, Ana Isabel Farfán-Sedano1, Juan Víctor San Martín-López1

  • 1Department of Internal Medicine, Hospital Universitario de Fuenlabrada, Madrid, Spain.

Insights

Baricitinib showed a trend toward improved outcomes for hospitalized COVID-19 patients when added to standard care. This exploratory trial suggests baricitinib may be a beneficial therapeutic strategy for severe coronavirus disease 2019.

Area of Science:

  • Infectious Diseases
  • Clinical Pharmacology
  • Pulmonology

Background:

  • Baricitinib and imatinib are potential therapies for COVID-19.
  • Their clinical utility in hospitalized patients requires further investigation.

Purpose of the Study:

  • To evaluate the efficacy of baricitinib and imatinib as adjuncts to standard care for hospitalized COVID-19 patients.
  • To determine if these kinase inhibitors offer a clinical benefit over standard care alone.

Main Methods:

  • Phase-2, open-label, randomized trial with a pick-the-winner design.
  • 165 hospitalized COVID-19 patients with symptom duration ≤10 days were randomized to imatinib, baricitinib, or standard care.
  • Primary outcome: time to clinical improvement; secondary outcomes: oxygenation, mortality, safety.

Main Results:

  • Baricitinib met predefined criteria for the most advantageous arm, though formal analysis showed no statistically significant differences.
  • A trend towards better clinical improvement (HR 1.41) and oxygen discontinuation (HR 1.46) was observed with baricitinib versus standard care.
  • No significant differences in additional therapies or safety were noted between groups.

Conclusions:

  • Baricitinib plus standard care demonstrated a trend towards improved outcomes in hospitalized COVID-19 patients.
  • This exploratory trial suggests baricitinib may be a promising therapeutic strategy for severe coronavirus disease 2019.

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