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

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.

Fracturas basicervicales tratadas con clavo intramedular con tornillo cefálico único. Serie de casos y revisión bibliográfica / Basicervical fractures treated with single-screw cephalomedullary nail. Case series and review of the literature

Introducción: Debido a la inestabilidad rotatoria de las fracturas basicervicales, en estudios recientes, se sugiere el uso de una hoja espiral, doble tornillo o tornillos de compresión en lugar del tornillo cefálico único. Objetivo: Analizar los resultados de las fracturas basicervicales tratadas con tornillo cefálico único en nuestro centro. Materiales y Métodos: Estudio retrospectivo de una serie de casos formada a partir de la revisión de todas las fracturas extracapsulares de fémur proximal tratadas con clavo intramedular con tornillo cefálico único entre 2016 y 2020. Se revisaron las historias clínicas y las radiografías de 269 pacientes, y solo 12 (6,4%) de ellos cumplieron los criterios de inclusión (fracturas en dos fragmentos no patológicas y con seguimiento mínimo de 9 meses). Se evaluaron diferentes factores, como distancia punta-ápex, posición del tornillo cefálico, calidad de la reducción, tiempo quirúrgico, complicaciones y reintervención, y se analizaron las posibles diferencias entre los pacientes que sufrieron complicaciones y los que no. Resultados: Cuatro de los 12 pacientes tuvieron una falla de la fijación que evolucionó a cut-out (única complicación identificada en la muestra). No hubo diferencias estadísticamente significativas entre pacientes con cut-outo sin cut-out respecto al resto de las variables analizadas. Conclusiones: La elevada proporción de pacientes que desarrollaroncut-out sugiere considerar la hipótesis de que debería evitarse fijar las fracturas basicervicales con tornillo cefálico único. Dada su alta tasa de inestabilidad rotatoria, podría ser más apropiado el uso de implantes que la contrarresten. Nivel de Evidencia: IV

Background: Given the rotational instability of basicervical fractures, recent studies suggest using a spiral blade, a second screw or compression screws instead of single-screw cephalomedullary nail fixation. Objective: The aim of our study is to analyze the outcomes of basicervical fractures treated with single-screw cephalomedullary nails. Materials and Methods: This is a retrospective study based on a case series identified from all extracapsular femoral fractures treated with single-screw cephalomedullary nails in our hospital from 2016 to 2020. Clinical records and radiographs from 269 patients were reviewed; only 12 (6.4%) subjects met inclusion criteria (two-part non-pathologic fractures with at least a 9-month follow-up). Different factors were evaluated, including: tip-apex distance, cephalic screw position, reduction quality, surgical time, complications and re-operations; differences between patients who experienced complications and those who did not were also assessed. Results: Four subjects out of the 12 included patients experienced fixation failure and implant cut-out. There were no statistically significant differences between subjects with and without cut-out regarding the analyzed variables. Conclusions: The high cut-out rate observed in our sample suggests considering the hypothesis that single-screw cephalomedullary nail fixation should not be used in basicervical fractures. Alternative fixation devices capable of controlling the high rotational instability of these fractures may be preferable. Level of Evidence: IV