ABSTRACT
Background and objectives: Remdesivir, an antiviral drug routinely used in the treatment of COVID-19 has not yet received FDA approval for use in patients with advanced kidney disease defined as GFR < 30 mL/min/1.73 m2. There is concern that an excipient in Veklury (Gilead's proprietary name for remdesivir) called sulfobutylether-beta-cyclodextrin (SBECD), which is renally cleared, may accumulate and reach toxic levels in patients with advanced kidney disease. The aim of this study was to summarize characteristics and incidence of adverse events of chronic kidney disease (CKD) patients who received remdesivir during hospitalization.Design, setting, participants, and measurements.We retrospectively studied patients admitted to one of several hospitals of the Mayo Clinic Foundation with the diagnosis of COVID-19 pneumonia and CKD. Laboratory values were also measured when remdesivir was first administered and stopped. All analyses were performed in the overall patient group and three separate subgroups of patients with a GFR ≥ 15, a GFR < 15 and dialysis, and a GFR < 15 and no dialysis. Results: A total of 444 CKD patients who were admitted to the hospital with COVID-19 pneumonia between May 2020 and September 2021 were included. Information was collected on patient characteristics, hospitalization, and adverse events. In the overall cohort, median age was 72 years (Range: 21-100 years), 55.2 % of patients were male, and most (86.5 %) were Caucasian. CKD stage was 3 for 114 patients (25.7 %), 4 for 229 patients (51.6 %), and 5 for 101 patients (22.7 %). A total of 146 patients (32.9 %) were admitted to the ICU, 103 (23.2 %) died in the hospital, and 120 (27.0 %) were on dialysis. The proportion of patients with an adverse event did not differ dramatically between the GFR ≥ 15 (20.9 %), GFR < 15 and dialysis (30.2 %), and GFR < 15 and no dialysis (32.3 %) groups (P = 0.12). Conclusion: Our results suggest that the use of remdesivir in patients with very severe CKD is safe, even in those who are not on renal replacement therapy.
ABSTRACT
Background. To determine whether CBC differentials of COVID+ inpatients can predict, at admission, both maximum oxygen requirements (MOR) and 30-day mortality. Methods. Based on an approved IRB protocol, CBC differentials from the first 3 days of hospitalization of 12 SARS CoV-2 infected patients were retrospectively extracted from hospital records and analyzed with a privately owned Pattern Recognition Software (PRS, US Patent 10,429,389 B2) previously validated in sepsis, HIV, and hantavirus infections. PRS partitions the data into subsets immunologically dissimilar from one another, although internally similar. Results. Regardless of the angle considered, the classic analysis -which measured the percentages of lymphocytes, monocytes, and neutrophils- did not distinguish outcomes (A). In contrast, non-overlapping patterns generated by the PRS differentiated 3 (left, vertical, and right) groups of patients (B). One subset was only composed of survivors (B). The remaining subsets included the highest oxygenation requirements (B). At least two immunologically interpretable, multi-cellular indicators distinguished the 3 data subsets with statistically significant differences (C, p≤ 0.05). Survivors (the left subset) showed lower N/L and/or higher M/L ratios than non-survivors (the vertical subset, C).Therefore, PRS partitioned the data into subsets that displayed both biological and significant differences. Because it offers visually explicit information, clinicians do not require a specialized training to interpret PRS-generated results. CBCs vs. outcomes - Software-analyzed CBCs vs. outcomes Conclusion. (1) Analysis of blood leukocyte data predicts MOR and 30-d mortality. (2) Real time PRS analysis facilitates personalized medical decisions. (3) PRS measures two dimensions rarely assessed: multi-cellularity and dynamics. (4) Even with very small datasets, PRS may achieve statistical significance. (5) Larger COVID+ infected cohort is being analyzed for potential commercialization.