ABSTRACT
INTRODUCTION: Treating systemic inflammation caused by SARS-COV 2 (COVID-19) has become a challenge for the clinician. Corticosteroids have been the turning point in the treatment of this disease. Preliminary data from Recovery clinical trial raises hope by showing that treatment with dexamethasone at doses of 6mg/day shows a reduction on morbidity in patients requiring added oxygen therapy. However, both the start day or what kind of corticosteroid, are still questions to be clarified. Since the pandemic beginning, we have observed large differences in the type of corticosteroid, dose and initiation of treatment. Our objective is to assess the predictive capacity of the characteristics of patients treated with methylprednisolone pulses to predict hospital discharge. MATERIALS AND METHODS: We presented a one-center observational study of a retrospective cohort. We included all patients admitted between 03/06/2020 and 05/15/2020 because of COVID-19. We have a total number of 1469 patients, of whom 322 received pulses of methylprednisolone. Previous analytical, radiographic, previous disease data were analyzed on these patients. The univariant analysis was performed using Chi-squared and the T test of Student according to the qualitative or quantitative nature of the variables respectively. For multivariate analysis, we have used binary logistic regression and ROC curves. RESULTS: The analysis resulted statistically significant in dyspnea, high blood pressure, dyslipidemia, stroke, ischemic heart disease, cognitive impairment, solid tumor, C-reactive protein (CRP), lymphopenia and d-dimer within 5 days of admission. Radiological progression and FIO2 input are factors that are associated with a worst prognosis in COVID-19 that receive pulses of methylprednisolone. Multivariate analysis shows that age, dyspnea and C-reactive protein are markers of hospital discharge with an area below the curve of 0.816. CONCLUSIONS: In patients with methylprednisolone pulses, the capacity of the predictive model for hospital discharge including variables collected at 5 days was (area under the curve) 0.816.
ABSTRACT
BACKGROUND: SARS-CoV-2 virus requires host proteases to cleave its spike protein to bind to its ACE2 target through a two-step furin-mediated entry mechanism. Aprotinin is a broad-spectrum protease inhibitor that has been employed as antiviral drug for other human respiratory viruses. Also, it has important anti-inflammatory properties for inhibiting the innate immunity contact system. METHODS: This was a multicentre, double-blind, randomized trial performed in four Spanish hospitals comparing standard treatment versus standard treatment + aprotinin for patients with COVID-19 between 20 May 2020 and 20 October 2021. The primary efficacy outcomes were length of hospital stay and ICU admission. The secondary endpoints were each of the primary efficacy outcomes and a composite of oxygen therapy, analytical parameters and death. Safety outcomes included adverse reactions to treatment during a 30-day follow-up period. Treatment was given for 11 days or till discharge. RESULTS: With almost identical analytical profiles, significant differences were observed in treatment time, which was 2 days lower in the aprotinin group (p = .002), and length of hospital admission, which was 5 days shorter in the aprotinin group (p = .003). The incidence of discharge was 2.19 times higher (HR: 2.188 [1.182-4.047]) in the aprotinin group than in the placebo group (p = .013). In addition, the aprotinin-treated group required less oxygen therapy and had no adverse reactions or side effects. CONCLUSION: Inhaled aprotinin may improve standard treatment and clinical outcomes in hospitalized patients with COVID-19, resulting in a shorter treatment time and hospitalization compared with the placebo group. The administration of aprotinin was safe.