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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.
Abstract:
Baricitinib and imatinib are considered therapies for coronavirus disease 2019 (COVID-19), but their ultimate clinical impact remains to be elucidated, so our objective is to determine whether these kinase inhibitors provide benefit when added to standard care in hospitalized COVID-19 patients. Phase-2, open-label, randomized trial with a pick-the-winner design conducted from September 2020 to June 2021 in a single Spanish center. Hospitalized adults with COVID-19 pneumonia and a symptom duration ≤10 days were assigned to 3 arms: imatinib (400 mg qd, 7 days) plus standard-care, baricitinib (4 mg qd, 7 days) plus standard-care, or standard-care alone. Primary outcome was time to clinical improvement (discharge alive or a reduction of 2 points in an ordinal scale of clinical status) compared on a day-by-day basis to identify differences ≥15% between the most and least favorable groups. Secondary outcomes included oxygenation and ventilatory support requirements, additional therapies administered, all-cause mortality, and safety. One hundred and sixty-five patients analyzed. Predefined criteria for selection of the most advantageous arm were met for baricitinib, but not for imatinib. However, no statistically significant differences were observed in formal analysis, but a trend toward better results in patients receiving baricitinib was found compared to standard care alone (hazard ratio [HR] for clinical improvement: 1.41, 95% confidence intervals [CI]: 0.96-2.06; HR for discontinuing oxygen: 1.46, 95% CI: 0.94-2.28). No differences were found regarding additional therapies administered or safety. Baricitinib plus standard care showed better results for hospitalized COVID-19 patients, being the most advantageous therapeutic strategy among those proposed in this exploratory clinical trial.
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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