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.
Subject(s)
COVID-19 , Adult , Humans , Imatinib Mesylate , SARS-CoV-2 , COVID-19 Drug Treatment , Treatment OutcomeABSTRACT
Objetivos: Analizar la evolución de los pacientes que fueron dados de alta del servicio de urgencias (SU) con neumonía compatible con COVID-19. Método: Se realiza el seguimiento de 102 pacientes dados de alta desde SU con diagnóstico de neumonía compatible con COVID-19 entre el 12 y el 21 de marzo de 2020 en un hospital del sur de Madrid. Se describen las principales variables utilizando mediana e intervalo intercuartil o usando frecuencias, según corresponda. La comparación entre tratamientos/pronóstico se realizó utilizando el test ji cuadrado, el test de Kruskal Wallis o el test de Mann-Whitney. Finalmente, se realizó un modelo de regresión logística. Resultados: La mayoría de los pacientes (74,5%) fueron tratados con hidroxicloroquina en monoterapia. La tasa de reingreso fue de 15,7% y de revisita a urgencias de 25,7%. El ingreso se relacionó con un LDL (lactato deshidrogena-sa) elevado (p = 0,011), creatincinasa (CK) elevada (p = 0,004) y linfopenia (p = 0,034). La hipertensión y la enferme-dad pulmonar obstructiva crónica se relacionaron con el ingreso, y la cardiopatía isquémica fue la comorbilidad que se asoció a mayor duración de la sintomatología. Conclusión: La linfopenia, LDH y CK pronosticaron mejor la necesidad de ingreso que otros marcadores clásicos en pacientes con clínica leve-moderada. El seguimiento telefónico demostró ser de utilidad ante la sobrecarga de recursos sanitarios. (AU)
Background and objective: We aimed to analyze the clinical course of patients discharged from our emergency departament (ED) with pneumonia symptoms compatible with a diagnosis of COVID-19. Methods: We followed 102 patients discharged home with a diagnosis of pneumonia compatible with COVID19 between March 12 and 21, 2020, in our hospital in the southern part of the autonomous community of Madrid. Descriptive statistics (medians and interquartile ranges or frequencies, as appropriate) were compiled for the main variables. Treatments and prognoses were compared with c2, KruskalWallis, or MannWhitney tests. The data then underwent logistic regression analysis. Results: Most patients (accounting for 74.5% of the discharges) were treated with hydroxychloroquine alone. The readmission rate was 15.7%; the ED revisiting rate was 25.7%. Admission was associated with an elevated lactate dehydrogenase (LDH) level (P=.011), elevated creatine kinase (CK) (P=.004), and lymphopenia (P=.034). Hypertension and chronic obstructive pulmonary disease were also related to admission. Ischemic heart disease was associated with longer duration of symptoms. Conclusions: Lymphopenia, and elevated LDH and CK levels predicted the need for hospital admission better than other traditional biological markers in patients with mild to moderate symptoms. Telephone follow-up proved useful for dealing with the overloading of health care services. (AU)
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Pandemics , Coronavirus Infections/epidemiology , Coronavirus Infections/blood , L-Lactate Dehydrogenase/blood , Lymphocyte Count , Prospective Studies , Spain/epidemiology , Creatine Kinase/bloodABSTRACT
OBJECTIVES: We aimed to analyze the clinical course of patients discharged from our emergency departament (ED) with pneumonia symptoms compatible with a diagnosis of COVID-19. MATERIAL AND METHODS: We followed 102 patients discharged home with a diagnosis of pneumonia compatible with COVID19 between March 12 and 21, 2020, in our hospital in the southern part of the autonomous community of Madrid. Descriptive statistics (medians and interquartile ranges or frequencies, as appropriate) were compiled for the main variables. Treatments and prognoses were compared with ô2, Kruskal-Wallis, or Mann-Whitney tests. The data then underwent logistic regression analysis. RESULTS: Most patients (accounting for 74.5% of the discharges) were treated with hydroxychloroquine alone. The readmission rate was 15.7%; the ED revisiting rate was 25.7%. Admission was associated with an elevated lactate dehydrogenase (LDH) level (P=.011), elevated creatine kinase (CK) (P=.004), and lymphopenia (P=.034). Hypertension and chronic obstructive pulmonary disease were also related to admission. Ischemic heart disease was associated with longer duration of symptoms. CONCLUSION: Lymphopenia, and elevated LDH and CK levels predicted the need for hospital admission better than other traditional biological markers in patients with mild to moderate symptoms. Telephone follow-up proved useful for dealing with the overloading of health care services.
OBJETIVO: Analizar la evolución de los pacientes que fueron dados de alta del servicio de urgencias (SU) con neumonía compatible con COVID-19. METODO: Se realiza el seguimiento de 102 pacientes dados de alta desde SU con diagnóstico de neumonía compatible con COVID-19 entre el 12 y el 21 de marzo de 2020 en un hospital del sur de Madrid. Se describen las principales variables utilizando mediana e intervalo intercuartil o usando frecuencias, según corresponda. La comparación entre tratamientos/pronóstico se realizó utilizando el test ji cuadrado, el test de Kruskal Wallis o el test de Mann-Whitney. Finalmente, se realizó un modelo de regresión logística. RESULTADOS: La mayoría de los pacientes (74,5%) fueron tratados con hidroxicloroquina en monoterapia. La tasa de reingreso fue de 15,7% y de revisita a urgencias de 25,7%. El ingreso se relacionó con un LDL (lactato deshidrogenasa) elevado (p = 0,011), creatincinasa (CK) elevada (p = 0,004) y linfopenia (p = 0,034). La hipertensión y la enfermedad pulmonar obstructiva crónica se relacionaron con el ingreso, y la cardiopatía isquémica fue la comorbilidad que se asoció a mayor duración de la sintomatología. CONCLUSIONES: La linfopenia, LDH y CK pronosticaron mejor la necesidad de ingreso que otros marcadores clásicos en pacientes con clínica leve-moderada. El seguimiento telefónico demostró ser de utilidad ante la sobrecarga de recursos sanitarios.