Methylprednisolone Pulses in Hospitalized COVID-19 Patients Without Respiratory Failure: A Randomized Controlled Trial.

Background: Corticosteroids are the cornerstone of the treatment of patients with COVID-19 admitted to hospital. However, whether corticosteroids can prevent respiratory worsening in hospitalized COVID-19 patients without oxygen requirements is currently unknown. Aims: To assess the efficacy of methylprednisolone pulses (MPP) in hospitalized COVID-19 patients with increased levels of inflammatory markers not requiring oxygen at baseline. Methods: Multicenter, parallel, randomized, double-blind, placebo-controlled trial conducted in Spain. Patients admitted for confirmed SARS-CoV-2 pneumonia with raised inflammatory markers (C-reactive protein >60 mg/L, interleukin-6 >40 pg/ml, or ferritin >1,000 µg/L) but without respiratory failure after the first week of symptom onset were randomized to receive a 3-day course of intravenous MPP (120 mg/day) or placebo. The primary outcome was treatment failure at 14 days, a composite variable including mortality, the need for ICU admission or mechanical ventilation, and clinical worsening, this last parameter defined as a PaO2/FiO2 ratio below 300; or a 15% decrease in the PaO2 from baseline, together with an increase in inflammatory markers or radiological progression. If clinical worsening occurred, patients received tocilizumab and unmasked corticosteroids. The secondary outcomes were 28-day mortality, adverse events, need for ICU admission or high-flow oxygen, length of hospital stay, SARS-CoV-2 clearance, and changes in laboratory parameters. Results: A total of 72 patients were randomized and 71 patients were analyzed (34 in the MPP group and 37 in the placebo group). Twenty patients presented with treatment failure (29.4 in the MPP group vs. 27.0% in the placebo group, p = 0.82), with no differences regarding the time to treatment failure between groups. There were no cases of death or mechanical ventilation requirements at 14 days post-randomization. The secondary outcomes were similar in MPP and placebo groups. Conclusions: A 3-day course of MPP after the first week of disease onset did not prevent respiratory deterioration in hospitalized COVID-19 patients with an inflammatory phenotype who did not require oxygen.

Experience in the use of remdesivir in patients with SARS-CoV-2 pneumonia.

OBJECTIVE: To describe the effectiveness and safety of remdesivir in patients with SARS-CoV-2 pneumonia in real-world clinical practice  conditions. METHOD: Retrospective observational study that included all adults with  SARS-CoV-2 pneumonia admitted at the Moisès Broggi Hospital and  treated with remdesivir between July 1st and November 7th, 2020.  Efficacy outcomes were time to recovery, 28-day mortality, length of  hospital stay, and the need of mechanical ventilation after treatment. The  main safetyrelated endpoint was elevation of transaminases after  treatment. RESULTS: A total of 111 patients were included of whom 97 (87.4%) were receiving low-flow oxygen therapy. Median time to recovery was 9  days [6-14]. Seven patients (6.3%) died at 28 days' follow-up. Median  length of hospital stay was 12 days [9-22] and 15 patients (13.5%)  needed mechanical ventilation after treatment with remdesivir. Severe  hypertransaminasemia was observed in 4 patients (4%). CONCLUSIONS: Clinical outcomes of patients with SARS-CoV-2 pneumonia on low-flow oxygen therapy treated with remdesivir were  similar to those published in clinical trials, both in terms of time to  recovery and 28-day mortality.

Objetivo: Describir la efectividad y seguridad de remdesivir en pacientes con neumonía por SARS-CoV-2 en condiciones de práctica clínica real.Método: Estudio observacional retrospectivo que incluyó a todos los pacientes tratados con remdesivir en el Hospital Moisès Broggi entre el 1 de julio y el 7 de noviembre de 2020. Como variables de efectividad se registraron el tiempo hasta la recuperación, la mortalidad a  los 28 días, la estancia hospitalaria y la proporción de pacientes que  requirió ventilación mecánica invasiva tras el tratamiento. Como variable  de seguridad se registró la alteración en las transaminasas tras el  tratamiento.Resultados: Se incluyeron 111 pacientes, 97 (87,4%) con oxigenoterapia de bajo flujo. El tiempo hasta la recuperación fue de 9 días [6-14] de  mediana y 7 pacientes (6,3%) habían fallecido a los 28 días de seguimiento. La estancia hospitalaria fue de 12 días [9-22] de mediana. Un total de 15 pacientes (13,5%) requirió ventilación mecánica  invasiva tras el tratamiento y 4 pacientes (4%) presentaron una alteración grave de las transaminasas.Conclusiones: El tratamiento con remdesivir en la práctica clínica habitual presenta resultados similares a los publicados en los ensayos  clínicos en el subgrupo de pacientes con oxigenoterapia de bajo flujo,  tanto en el tiempo hasta la recuperación como en la mortalidad a los 28  días.

Retrospective assessment of potential interaction between levofloxacin and warfarin.

OBJECTIVE: There is currently a controversy regarding interactions between levofloxacin and warfarin. The aim of this study was to determine the clinical relevance of this interaction in our setting. SETTING: A university hospital in Barcelona, Spain. METHODS: We carried out a retrospective evaluation of all patients hospitalized in our hospital during the period 2000-2005, selecting all those concomitantly treated with levofloxacin and warfarin for the study. The following data were compiled: demographic information, concomitant medication, comorbid conditions, and relevant analytical parameters, particularly the international normalized ratio (INR), including values taken before, during, and after concomitant administration of the two study drugs. Patients for whom INR values during concomitant administration were not available were excluded. Differences in INR before and during the potential interaction, and before and after the interaction were analyzed with the Wilcoxon t test using SPSS (V12.0). In addition, patients were stratified according to presence or not of toxic habits (smoking/alcohol consumption) to investigate the possible impact of these factors on the interaction under study. RESULTS: Among the 30 patients identified, 9 were excluded because INR data during concomitant administration of warfarin and levofloxacin were not available. Statistical analysis demonstrated significant increase in INR (P = 0.001) following addition of levofloxacin to warfarin therapy. CONCLUSIONS: The results of this study reaffirm the hypothesis that concomitant administration of levofloxacin and warfarin leads to INR increase; hence close monitoring of INR is advisable when patients are prescribed this combination of drugs.