Efficacy Of Remdesivir For Hospitalized COVID-19 Patients With End Stage Renal Disease
Dec 04, 2023
Abstract
BACKGROUND Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, there has been a widespread use of remdesivir in adults and children. There is little known information about its outcomes in patients with end-stage renal disease who are on dialysis.
AIM To assess the clinical outcomes with use of remdesivir in adult patients with end-stage kidney failure on hemodialysis.
METHODS A retrospective, multicenter study was conducted on patients with end-stage renal disease on hemodialysis who were discharged after treatment for COVID-19 between April 1, 2020 and December 31, 2020. Primary endpoints were oxygen requirements, time to mortality and escalation of care needing mechanical ventilation.
CISTANCHE DIETARY SUPPLEMENT SEXUAL ENHANCEMENT
PHENYLETHANOID GLYCOSIDES 75% ECHINACOSIDE 30% ACTEOSIDE 12%
RESULTS
A total of 45 patients were included in the study. Twenty patients received remdesivir, and 25 patients did not receive remdesivir. Most patients were caucasian, females with diabetes mellitus and hypertension being the commonest comorbidities. There was a trend towards reduced oxygen requirement (beta = - 25.93, X2 (1) = 6.65, P = 0.0099, probability of requiring mechanical ventilation (beta = -28.52, X2 (1) = 22.98, P < 0.0001) and mortality (beta = -5.03, X2 (1) = 7.41, P = 0.0065) in patients that received redeliver compared to the control group
CONCLUSION Larger studies are justified to study the effects of remdesivir in this high-risk population with end-stage kidney disease on dialysis.
Key Words: COVID-19; Remdesivir; End stage renal disease; Dialysis; Hemodialysis; Kidney disease
INTRODUCTION
Coronavirus disease 2019 (COVID-19) is a clinical syndrome arising from infection with the severe acute respiratory syndrome - coronavirus 2 (SARS-CoV-2) coronavirus that has led to several hospitalizations and intensive care unit admissions. Remdesivir, a viral RNA polymerase inhibitor, has demonstrated in vitro activity against viruses such as Middle East Respiratory Syndrome - CoV (MERS-CoV), Ebola, and SARSCoV1.
In the Adaptive COVID-19 Treatment Trial-1 (ACTT-1), remdesivir was noted to reduce the median time to recovery when compared to the placebo group (10 vs 15 d) [1]. The Infectious Diseases Society of America (IDSA) recommended the use of remdesivir in hospitalized patients with severe COVID-19 with SpO2 < 94%, including patients on supplemental oxygen or mechanical ventilation[2]. The World Health Organization (WHO) issued a 'weak or conditional' recommendation against the use of remdesivir in hospitalized COVID-19 patients[3]. Despite this, the use of remdesivir is widespread in hospitalized COVID-19 patients. Many of the clinical trials on remdesivir excluded COVID-19 patients with severe renal dysfunction (CrCl < 30 mL/min/1.73m2 ). Little is known about the clinical outcomes of use of remdesivir in COVID-19 patients with severe renal dysfunction or end-stage renal disease (ESRD) who are on hemodialysis (HD).
As remdesivir has poor water solubility, Sulfobutylether-β-Cyclodextrin (SBECD) is added to the intravenous preparation as a vehicle. Dialysis and renal replacement therapy readily remove SBECD, and significant accumulation of SBECD only occurs when dialysis is held for prolonged periods in ESRD patients. Voriconazole is another medication that has been safely used in patients with kidney failure using the same carrier (SBECD)[4].
We hypothesize that adding remdesivir to dexamethasone as part of the treatment regimen in COVID-19 patients with ESRD may impact the overall length of stay, need for supplemental oxygen, mortality, and mechanical ventilation. This study aimed to evaluate the feasibility and efficacy of using remdesivir in patients with COVID-19 and ESRD on HD.
MATERIALS AND METHODS
We collected data from two quaternary, acute care hospitals, Rhode Island Hospital (RIH) and The Miriam Hospital (TMH), located in Providence, Rhode Island. All hospitalized patients above the age of 18 years with ESRD on HD from April 1 to December 31, 2020, with a positive polymerase chain reaction (PCR) nasopharyngeal or oropharyngeal SARS-CoV-2 swab were screened for potential study inclusion (Figure 1). ESRD was defined as a GFR of less than 15 mL/min/1.73m2 according to the chronic kidney disease epidemiology collaboration (CKD-EPI) formula. The study was reviewed and approved by the Institutional Review Board of TMH. Data was collected by physicians in the Division of Hospital Medicine at Miriam Hospital (an affiliate of Warren Alpert Medical School of Brown University).
Patients with moderate disease included patients with CRP levels between 50-200 mg/L (normal 0-10 mg/L) and 2-6L/min of oxygen requirement. Patients with severe disease included patients with CRP levels greater than 200 mg/L and oxygen requirements greater than 6 L/min. Prone positioning was instituted in all patients with moderate to severe disease if they could tolerate it.
Remdesivir group selection
All patients with ESRD on HD hospitalized with PCR-confirmed COVID-19 in both hospitals were screened for inclusion. To be considered eligible for study inclusion, patients had to meet the following criteria: (1) Hospitalized for at least 48 h, aged ≥18 years; (2) SARS-CoV-2 infection confirmed by RNA PCR test; (3) SpO2 ≤ 94% on room air or requiring supplemental oxygen; and (4) Presence of radiographic evidence of pulmonary infiltrates. These patients were given 200mg of intravenous (iv) remdesivir on day one, followed by 100 mg once daily for 2-10 d or until discharge, death or if there was elevated AST/ALT, with levels greater than ten times the upper limit of normal.
Control group selection
For the purposes of this study, we created a control group consisting of hospitalized ESRD patients on HD with PCR-confirmed COVID-19 who did not receive remdesivir (during the same study period). To identify controls, we screened all patients with ESRD on HD who were admitted to both hospitals from April 1 to December 31, 2020 and did not receive remdesivir. After identifying those patients and to minimize selection bias, we used the following inclusion criteria: (1) Hospitalized for at least 48 h, aged ≥18 years; (2) SARS-CoV-2 infection confirmed by PCR test; (3) SpO2 ≤ 94% on room air or requiring supplemental oxygen; and (4) Presence of radiographic evidence of pulmonary infiltrates.
Patients who met the following criteria were excluded: (1) Patients < 18 years of age; (2) Patients with ESRD who received renal transplant and are not on dialysis; and (3) Patients with AST, ALT > 10 times the upper limit of normal. The Nephrology service at Miriam Hospital (an affiliate of Alpert Medical School of Brown University) followed these patients while they were admitted. Patients also received antibiotics if there was a concern for superimposed bacterial infection in addition to the other interventions keeping in line with the institutional standard of care.
Endpoints
Our primary endpoint was comparing the oxygen requirements, time to mortality and escalation of care needing mechanical ventilation in patients that received remdesivir vs control group.
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