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1.
BMC Nephrol ; 23(1): 135, 2022 Apr 07.
Article in English | MEDLINE | ID: covidwho-1779614

ABSTRACT

BACKGROUND: The flare of immune-mediated disease following coronavirus disease of 2019 (COVID-19) vaccination is a rare adverse event following immunization. De novo, as well as relapsing IgA nephropathy (IgAN) cases, have been reported following either mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) vaccination. To our knowledge, the majority of IgAN relapses did not result in severe acute kidney injury (AKI) and resolved spontaneously. CASE PRESENTATION: This is a case of a 54-year-old female with a previous diagnosis of IgAN who developed IgAN relapse following the second dose of Moderna vaccine. Gross hematuria developed 2 days after vaccination, which was accompanied by significant AKI. Kidney biopsy showed mild tubular atrophy and IgA staining in mesangium without crescent formation. Significant improvement in serum creatinine (Cr) was observed on day 10 after initiating prednisone. Cr came back to normal within 3 months after initiating corticosteroid. CONCLUSION: COVID-19 vaccination is associated with a flare of IgAN that may cause significant AKI. Steroid therapy is associated with recovery. IgAN flare after COVID-19 vaccination should be closely monitored to elucidate any adverse effect associated with the novel vaccine.


Subject(s)
Acute Kidney Injury , COVID-19 , Glomerulonephritis, IGA , Acute Kidney Injury/chemically induced , Acute Kidney Injury/complications , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Chronic Disease , Female , Glomerulonephritis, IGA/diagnosis , Humans , Middle Aged , Recurrence , Vaccination
2.
Ren Fail ; 44(1): 415-425, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1730388

ABSTRACT

OBJECTIVES: Hydroxychloroquine/chloroquine has been widely used as part of the standard treatment for patients with coronavirus disease 2019 (COVID-19). We conducted a systematic review and meta-analysis to determine whether hydroxychloroquine/chloroquine increases the risk of acute kidney injury (AKI) in COVID-19 patients. METHODS: PubMed and Embase were searched for related publications from inception to Dec 31, 2021, including randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs) comparing the risk of AKI and/or increased creatinine in COVID-19 patients receiving hydroxychloroquine/chloroquine and other controls (active treatment and placebo). We conducted separate meta-analyses for RCTs and NRSIs based on fixed-effect model, with odds ratios (ORs) being considered as effect sizes. RESULTS: We included 21 studies in the analysis, with 12 were RCTs. Based on the RCTs, compared to placebo, the OR was 1.19 (95% confidence interval [CI]: 0.86, 1.64; p = .30, n = 4, moderate quality) for AKI and 1.00 (95%CI: 0.64, 1.56; p = .99, n = 5, moderate quality) for increased creatinine for patients received hydroxychloroquine/chloroquine treatment; compared to active treatment, the odds was 1.28 (95%CI: 0.65, 2.53; p = .47, n = 2, low quality) for AKI and 0.64 (95%CI: 0.13, 3.20; p = .59, n = 1, low quality) for increased creatine. Evidence from NRSIs showed slightly increased odds of AKI, with low quality. CONCLUSION: Based on current available studies which were graded as low to moderate quality, there is insufficient evidence to conclude that hydroxychloroquine/chloroquine use is associated with increased risk of AKI or raised creatinine. Abbreviations: AKI: acute kidney injury; COVID-19: Coronavirus Disease 2019; RCT: randomized controlled trials; NRSI: non-randomized studies of interventions; OR: odds ratios; ROBIS-I: Risk Of Bias In Non-randomized Studies - of Interventions.


Subject(s)
Acute Kidney Injury/chemically induced , Acute Kidney Injury/epidemiology , Antirheumatic Agents/adverse effects , COVID-19/drug therapy , Hydroxychloroquine/adverse effects , Humans
3.
Saudi J Kidney Dis Transpl ; 32(4): 1034-1042, 2021.
Article in English | MEDLINE | ID: covidwho-1715893

ABSTRACT

We aimed to study the effect of remdesivir therapy on renal and hepatic function in coronavirus disease-2019 (COVID-19) patients with renal dysfunction at baseline or after starting therapy and identify the factors, if any, related to the efficacy of remdesivir therapy on patient outcome. Patients included in the study were those who met all the following criteria irrespective of baseline glomerular filtration rate [including those already on maintenance hemodialysis (HD)] or baseline deranged liver function test. (1) Age >18 years, (2) COVID-19 reverse transcriptase-polymerase chain reaction positive, (3) Meeting criteria for administration of remdesivir - [any one of the following: (a) COVID-19 pneumonia with respiratory rate >30/min or SPO2<94% on room air, (b) Acute respiratory distress syndrome (ARDS)]. (4) Renal dysfunction at baseline, during or within 48 h of completion of therapy. Thirty-four patients had renal dysfunction at baseline or developed it after remdesivir therapy - 16 were acute kidney injury (AKI), 10 chronic kidney diseases (CKD), four CKD stage 5D, and four were postrenal transplant. The overall mortality was 18/34 (52.9%). Eight out of 30 (26.66%) needed HD during or after therapy and of these, 15 died and among 15 survivors, 14 returned to their baseline renal function after cessation of therapy, one patient is still dialysis dependent. In the dialysis-dependent CKD (n = 4) subgroup, three died and one was discharged. In the postrenal transplant (n = 4) group, all developed AKI during or after the completion of therapy. None required HD, two returned to their baseline renal function, and two died. Only five had alanine aminotransferase elevation (×1 upper limit of normal) during or within 48 h of completion of therapy - three died and two returned to baseline. Lower PaO2/FiO2 (severe ARDS) (P = 0.0001), higher C-reactive protein (P = 0.022), higher serum lactate dehydrogenase (P = 0.038), and duration of symptoms before starting therapy (P = 0.05) were statistically significant variables at baseline associated with higher mortality. Remdesivir can be tried in moderate-to-severe COVID-19 cases with renal dysfunction as a complete recovery of renal function was noted in survivors. However, larger and well-controlled studies evaluating its safety and efficacy in patients with AKI and CKD are needed.


Subject(s)
Acute Kidney Injury , COVID-19 , Acute Kidney Injury/chemically induced , Acute Kidney Injury/epidemiology , Acute Kidney Injury/therapy , Adenosine Monophosphate/analogs & derivatives , Adolescent , Alanine/analogs & derivatives , COVID-19/drug therapy , Humans , Kidney/physiology , SARS-CoV-2
4.
Medicina (Kaunas) ; 58(2)2022 Jan 30.
Article in English | MEDLINE | ID: covidwho-1715541

ABSTRACT

Immunotherapy with immune checkpoint inhibitors represents nowadays a marked improvement in cancer treatment. Nevertheless, they can cause severe toxicities that put the patient at high risk, often requiring aggressive treatment. We present the case of a female patient who developed a severe immune-related adverse reaction to Pembrolizumab prescribed for melanoma treatment. Her array of symptoms, which presented a few days after last drug administration, consisted of severe neurological deficit, severe renal failure, polymyositis, and hyperthyroidism. Treatment required the immediate interruption of the trigger drug, infusion of high dose steroids, renal replacement therapy, plasmapheresis, and methimazole, as will be further discussed.


Subject(s)
Acute Kidney Injury , Antibodies, Monoclonal, Humanized/adverse effects , Melanoma , Acute Kidney Injury/chemically induced , Acute Kidney Injury/therapy , Female , Humans , Immunotherapy , Melanoma/drug therapy
5.
Arthritis Res Ther ; 24(1): 6, 2022 01 03.
Article in English | MEDLINE | ID: covidwho-1590005

ABSTRACT

BACKGROUND: Hydroxychloroquine (HCQ) has been recommended as a basic treatment for lupus nephritis (LN) during this decade based on its ability to improve LN-related renal immune-mediated inflammatory lesions. As a classical lysosomal inhibitor, HCQ may inhibit lysosomal degradation and disrupt protective autophagy in proximal tubular epithelial cells (PTECs). Therefore, the final renal effects of HCQ on LN need to be clarified. METHOD: HCQ was administered on spontaneous female MRL/lpr LN mice with severe proteinuria daily for 4 weeks. Moreover, the MRL/lpr mice with proteinuric LN were subjected to cisplatin-induced or unilateral ischemia/reperfusion (I/R)-induced acute kidney injury (AKI) after 2 weeks of HCQ preadministration. RESULTS: As expected, HCQ treatment increased the survival ratio and downregulated the levels of serum creatinine in the mice with LN, ameliorated renal lesions, and inhibited renal interstitial inflammation. Unexpectedly, HCQ preadministration significantly increased susceptibility to and delayed the recovery of AKI complicated by LN, as demonstrated by an increase in PTEC apoptosis and expression of the tubular injury marker KIM-1 as well as the retardation of PTEC replenishment. HCQ preadministration suppressed the proliferation of PTECs by arresting cells in G1/S phase and upregulated the expression of cell cycle inhibitors. Furthermore, HCQ preadministration disrupted the PTEC autophagy-lysosomal pathway and accelerated PTEC senescence. CONCLUSION: HCQ treatment may increase susceptibility and delay the recovery of AKI complicated by LN despite its ability to improve LN-related renal immune-mediated inflammatory lesions. The probable mechanism involves accelerated apoptosis and inhibited proliferation of PTECs via autophagy-lysosomal pathway disruption and senescence promotion.


Subject(s)
Acute Kidney Injury , Lupus Nephritis , Acute Kidney Injury/chemically induced , Animals , Female , Hydroxychloroquine/pharmacology , Kidney/pathology , Mice , Mice, Inbred MRL lpr
7.
J Cardiovasc Med (Hagerstown) ; 23(4): 264-271, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1562166

ABSTRACT

AIMS: To estimate if chronic anticoagulant (CAC) treatment is associated with morbidity and mortality outcomes of patients hospitalized for SARS-CoV-2 infection. METHODS: In this European multicentric cohort study, we included 1186 patients of whom 144 were on CAC (12.1%) with positive coronavirus disease 2019 testing between 1 February and 30 July 2020. The average treatment effect (ATE) analysis with a propensity score-matching (PSM) algorithm was used to estimate the impact of CAC on the primary outcomes defined as in-hospital death, major and minor bleeding events, cardiovascular complications (CCI), and acute kidney injury (AKI). We also investigated if different dosages of in-hospital heparin were associated with in-hospital survival. RESULTS: In unadjusted populations, primary outcomes were significantly higher among CAC patients compared with non-CAC patients: all-cause death (35% vs. 18% P < 0.001), major and minor bleeding (14% vs. 8% P = 0.026; 25% vs. 17% P = 0.014), CCI (27% vs. 14% P < 0.001), and AKI (42% vs. 19% P < 0.001). In ATE analysis with PSM, there was no significant association between CAC and primary outcomes except for an increased incidence of AKI (ATE +10.2%, 95% confidence interval 0.3-20.1%, P = 0.044). Conversely, in-hospital heparin, regardless of dose, was associated with a significantly higher survival compared with no anticoagulation. CONCLUSIONS: The use of CAC was not associated with the primary outcomes except for the increase in AKI. However, in the adjusted survival analysis, any dose of in-hospital anticoagulation was associated with significantly higher survival compared with no anticoagulation.


Subject(s)
Acute Kidney Injury , COVID-19 , Acute Kidney Injury/chemically induced , Acute Kidney Injury/epidemiology , Anticoagulants/adverse effects , COVID-19/complications , COVID-19 Testing , Cohort Studies , Hospital Mortality , Hospitals , Humans , Retrospective Studies , Risk Factors , SARS-CoV-2
8.
Front Biosci (Schol Ed) ; 13(2): 202-207, 2021 12 03.
Article in English | MEDLINE | ID: covidwho-1559317

ABSTRACT

COVID-19, provoked by SARS-CoV-2, constitutes a global health issue with high rates of mortality. The presence of diabetes mellitus is associated with severe coronavirus COVID-19 as it is related to increased death rates in patients admitted to the intensive care unit. Acute kidney injury is a frequent complication among patients hospitalized for COVID-19 and is met with high morbidity and mortality. Here, we present a case of a diabetic patient with acute kidney injury, metformin-associated lactic acidosis, and COVID-19. Lactic acidosis is a relatively rare but noteworthy complication of metformin use. However, the combination of those life-threatening situations could prove fatal for the patients despite optimal medical care.


Subject(s)
Acidosis, Lactic , Acute Kidney Injury , COVID-19 , Diabetes Mellitus, Type 2 , Metformin , Acidosis, Lactic/chemically induced , Acute Kidney Injury/chemically induced , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Humans , Hypoglycemic Agents/adverse effects , Metformin/adverse effects , SARS-CoV-2
9.
J Gen Intern Med ; 36(11): 3487-3496, 2021 11.
Article in English | MEDLINE | ID: covidwho-1525603

ABSTRACT

BACKGROUND: Black individuals have been disproportionately affected by the coronavirus disease 2019 (COVID-19). However, it remains unclear whether there are any biological factors that predispose Black patients to COVID-19-related morbidity and mortality. OBJECTIVE: To compare in-hospital morbidity, mortality, and inflammatory marker levels between Black and White hospitalized COVID-19 patients. DESIGN AND PARTICIPANTS: This single-center retrospective cohort study analyzed data for Black and White patients aged ≥18 years hospitalized with a positive SARS-CoV-2 PCR test between March 1, 2020, and August 4, 2020. MAIN MEASURES: The exposure was self-identified race documented in the medical record. The primary outcome of was in-hospital death. Secondary outcomes included intensive care unit admission, hospital morbidities, and inflammatory marker levels. KEY RESULTS: A total of 1,424 Black and White patients were identified. The mean ± SD age was 56.1 ± 17.4 years, and 663 (44.5%) were female. There were 683 (48.0%) Black and 741 (52.0%) White patients. In the univariate analysis, Black patients had longer hospital stays (8.1 ± 10.2 vs. 6.7 ± 8.3 days, p = 0.011) and tended to have higher rates of in-hospital death (11.0% vs. 7.3%), myocardial infarction (6.9% vs. 4.5%), pulmonary embolism (PE; 5.0% vs. 2.3%), and acute kidney injury (AKI; 39.4% vs. 23.1%) than White patients (p <0.05). However, after adjusting for potential confounders, only PE (adjusted odds ratio [aOR] 2.07, 95% CI, 1.13-3.79) and AKI (aOR 2.16, 95% CI, 1.57-2.97) were statistically significantly associated with Black race. In comparison with White patients, Black patients had statistically significantly higher peak plasma D-dimer (standardized ß = 0.10), erythrocyte sedimentation rate (standardized ß = 0.13), ferritin (standardized ß = 0.09), and lactate dehydrogenase (standardized ß = 0.11), after adjusting for potential confounders (p<0.05). CONCLUSIONS: Black hospitalized COVID-19 patients had increased risks of developing PE and AKI and higher inflammatory marker levels compared with White patients. This observation may be explained by differences in the prevalence and severity of underlying comorbidities and other unmeasured biologic risk factors between Black and White patients. Future research is needed to investigate the mechanism of these observed differences in outcomes of severe COVID-19 infection in Black versus White patients.


Subject(s)
Acute Kidney Injury , COVID-19 , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Adolescent , Adult , Aged , Female , Hospital Mortality , Hospitalization , Humans , Inflammation/epidemiology , Middle Aged , Retrospective Studies , Risk Factors , SARS-CoV-2
10.
Nephrol Dial Transplant ; 37(2): 201-202, 2022 01 25.
Article in English | MEDLINE | ID: covidwho-1522264
11.
Ther Drug Monit ; 43(4): 451-454, 2021 08 01.
Article in English | MEDLINE | ID: covidwho-1501177

ABSTRACT

OBJECTIVE: The authors report on a case of a 59-year-old man hospitalized in the intensive care unit because of severe SARS-COV-2 infection (COVID-19). BACKGROUND: The patient had several comorbidities, including liver cirrhosis. He developed ventilation-associated bacterial pneumonia for which he was administered cefepime at an initial dose of 2 g/8 hours. Therapeutic drug monitoring was performed, showing overexposure with an initial trough concentration of >60 mg/L. METHODS: Analysis of pharmacokinetic data and model-based dose adjustment was performed using BestDose software. RESULTS: The patient had unexpected pharmacokinetic parameter values. Serum creatinine was only moderately increased, whereas measured creatinine clearance based on urine collection showed impaired renal function. Bacterial minimum inhibitory concentration was also considered in the dosing decisions. After dose reduction to 0.5 g/8 hours, the cefepime trough concentration progressively declined and reached the target values by the end of the therapy. A post-hoc analysis provided a different interpretation of drug overexposure. CONCLUSION: This case report illustrates how physiological, microbiological, and drug concentration data can be used for model-based dosage individualization of cefepime in intensive care unit patients.


Subject(s)
Anti-Bacterial Agents/pharmacokinetics , Cefepime/pharmacokinetics , Critical Illness/therapy , Drug Dosage Calculations , Precision Medicine/methods , Acute Kidney Injury/blood , Acute Kidney Injury/chemically induced , Acute Kidney Injury/prevention & control , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Cefepime/administration & dosage , Cefepime/adverse effects , Humans , Male , Middle Aged
12.
J Med Virol ; 94(1): 349-356, 2022 01.
Article in English | MEDLINE | ID: covidwho-1427138

ABSTRACT

Corticosteroid dosing in the range of 0.5-2 mg/kg/day of methylprednisolone equivalents has become a standard part of the management of intensive care unit (ICU) patients with COVID-19 pneumonia based on positive results of randomized trials and a meta-analysis. Alongside such conventional dosing, administration of 1 gm of methylprednisolone daily (pulse dosing) has also been reported in the literature with claims of favorable outcomes. Comparisons between such disparate approaches to corticosteroids for Coronavirus disease 2019 (COVID-19) pneumonia are lacking. In this retrospective study of patients admitted to the ICU with COVID-19 pneumonia, we compared patients treated with 0.5-2 mg/kg/day in methylprednisolone equivalents (high-dose corticosteroids) and patients treated with 1 gm of methylprednisolone (pulse-dose corticosteroids) to those who did not receive any corticosteroids. The endpoints of interest were hospital mortality, ICU-free days at Day 28, and complications potentially attributable to corticosteroids. Pulse-dose corticosteroid therapy was associated with a significant increase in ICU-free days at Day 28 compared to no receipt: adjusted relative risk (aRR): 1.45 (95% confidence interval [CI]: 1.05-2.02; p = 0.03) and compared with high-dose corticosteroid administration (p = 0.003). Nonetheless, receipt of high-dose corticosteroids-but not of pulse-dose corticosteroids-significantly reduced the odds of hospital mortality compared to no receipt: adjusted Odds ratio (aOR) 0.31 (95% CI: 0.12-0.77; p = 0.01). High-dose corticosteroids reduced mortality compared to pulse-dose corticosteroids (p = 0.04). Pulse-dose corticosteroids-but not high-dose corticosteroids-significantly increased the odds of acute kidney injury requiring renal replacement therapy compared to no receipt: aOR 3.53 (95% CI: 1.27-9.82; p = 0.02). The odds of this complication were also significantly higher in the pulse-dose group when compared to the high-dose group (p = 0.05 for the comparison). In this single-center study, pulse-dose corticosteroid therapy for COVID-19 pneumonia in the ICU was associated with an increase in ICU-free days but failed to impact hospital mortality, perhaps because of its association with development of severe renal failure. In line with existing trial data, the effect of high-dose corticosteroids on mortality was favorable.


Subject(s)
Acute Kidney Injury/chemically induced , Adrenal Cortex Hormones/therapeutic use , COVID-19/drug therapy , COVID-19/mortality , Methylprednisolone/therapeutic use , Pulse Therapy, Drug/adverse effects , Acute Kidney Injury/epidemiology , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/adverse effects , Critical Care/methods , Hospital Mortality , Humans , Methylprednisolone/administration & dosage , Methylprednisolone/adverse effects , Pulse Therapy, Drug/methods , Retrospective Studies , SARS-CoV-2/drug effects
13.
BMC Nephrol ; 22(1): 297, 2021 08 31.
Article in English | MEDLINE | ID: covidwho-1381255

ABSTRACT

BACKGROUND: Kidney disease and renal failure are associated with hospital deaths in patients with COVID - 19. We aimed to test if contrast enhancement affects short-term renal function in hospitalized COVID - 19 patients. METHODS: Plasma creatinine (P-creatinine) was measured on the day of computed tomography (CT) and 24 h, 48 h, and 4-10 days after CT. Contrast-enhanced (n = 142) and unenhanced (n = 24) groups were subdivided, based on estimated glomerular filtration rates (eGFR), > 60 and ≤ 60 ml/min/1.73 m2. Contrast-induced acute renal failure (CI-AKI) was defined as ≥27 µmol/L increase or a > 50% rise in P-creatinine from CT or initiation of renal replacement therapy during follow-up. Patients with renal replacement therapy were studied separately. We evaluated factors associated with a > 50% rise in P-creatinine at 48 h and at 4-10 days after contrast-enhanced CT. RESULTS: Median P-creatinine at 24-48 h and days 4-10 post-CT in patients with eGFR> 60 and eGFR≥30-60 in contrast-enhanced and unenhanced groups did not differ from basal values. CI-AKI was observed at 48 h and at 4-10 days post contrast administration in 24 and 36% (n = 5/14) of patients with eGFR≥30-60. Corresponding figures in the eGFR> 60 contrast-enhanced CT group were 5 and 5% respectively, (p < 0.037 and p < 0.001, Pearson χ2 test). In the former group, four of the five patients died within 30 days. Odds ratio analysis showed that an eGFR≥30-60 and 30-day mortality were associated with CK-AKI both at 48 h and 4-10 days after contrast-enhanced CT. CONCLUSION: Patients with COVID - 19 and eGFR≥30-60 had a high frequency of CK-AKI at 48 h and at 4-10 days after contrast administration, which was associated with increased 30-day mortality. For patients with eGFR≥30-60, we recommend strict indications are practiced for contrast-enhanced CT. Contrast-enhanced CT had a modest effect in patients with eGFR> 60.


Subject(s)
Acute Kidney Injury/chemically induced , COVID-19/complications , Contrast Media/adverse effects , Creatinine/blood , Iodine/adverse effects , Kidney/drug effects , Acute Kidney Injury/blood , Acute Kidney Injury/mortality , Acute Kidney Injury/therapy , Aged , COVID-19/blood , COVID-19/mortality , COVID-19/physiopathology , Female , Glomerular Filtration Rate , Humans , Kidney/diagnostic imaging , Kidney/physiopathology , Male , Middle Aged , Odds Ratio , Regression Analysis , Renal Replacement Therapy , Retrospective Studies , Time Factors , Tomography, X-Ray Computed
14.
Bratisl Lek Listy ; 122(9): 643-646, 2021.
Article in English | MEDLINE | ID: covidwho-1380030

ABSTRACT

METHODS: Forty-two COVID-19 patients who underwent emergency PCI due to the diagnosis of acute coronary syndrome were included in the study. Mean age was 63±14.76 and males accounted for 81 % (34/42). Contrast-induced acute kidney injury (CI-AKI) was defined as absolute increase in serum creatinine level by 0.3 mg/dL above baseline within 48 hours of contrast exposure. Patients were divided into two groups according to CI-AKI development following coronary angiography. RESULTS: CI-AKI developed in 33.3 % (14/42) of the patients. Pre-procedure e-GFR (p=0.028), serum albumin levels (p=0.021), and ejection fraction (p=0.039) were lower in the CI-AKI group. Whereas the platelet/lymphocyte ratio was significantly lower in the non-CI-AKI group (p=0.010). CONCLUSIONS: Our study results demonstrated that patients suffering from COVID-19 had a high risk of CI-AKI development following coronary angiography (Tab. 1, Ref. 36).


Subject(s)
Acute Kidney Injury , COVID-19 , Contrast Media , Percutaneous Coronary Intervention , Acute Kidney Injury/chemically induced , COVID-19/complications , Contrast Media/adverse effects , Female , Humans , Male , Middle Aged , Risk Factors
16.
Expert Opin Drug Saf ; 20(12): 1559-1564, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1334105

ABSTRACT

Background: Remdesivir has been used for treating patients with moderate to severe coronavirus disease 2019 (COVID-19) although there is conflicting evidence regarding its usefulness. Data regarding its safety largely come from the clinical trials conducted to support its emergency use authorization (EUA). This study aimed to identify the adverse events of remdesivir with disproportionately high reporting using real-world data.Research design and methods: The adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) by health-care professionals for drugs that have received EUA or approved for the treatment of COVID-19 in the US were studied. Adisproportionality analysis was performed to determine adverse events more frequently reported with remdesivir compared with other COVID-19 drugs in the database.Results: Elevated liver enzymes, acute kidney injury, raised blood creatinine levels, bradycardia, cardiac arrest, and death had disproportionately higher reporting with remdesivir as asuspect drug compared with other drugs. There is no significant difference in the reporting of these events based on patient sex or age.Conclusions: Our study confirms the drug label information regarding liver enzyme elevation. The renal and cardiac safety signals identified necessitate reevaluation for potential drug-labeling changes.


Subject(s)
Acute Kidney Injury , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Bradycardia , COVID-19 , Drug-Related Side Effects and Adverse Reactions , Liver Function Tests , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Adenosine Monophosphate/administration & dosage , Adenosine Monophosphate/adverse effects , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Alanine/administration & dosage , Alanine/adverse effects , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Bradycardia/chemically induced , Bradycardia/diagnosis , COVID-19/complications , COVID-19/drug therapy , COVID-19/epidemiology , Drug Approval/methods , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Humans , Liver Function Tests/methods , Liver Function Tests/statistics & numerical data , Male , Middle Aged , SARS-CoV-2 , United States/epidemiology , United States Food and Drug Administration/statistics & numerical data
17.
Pharmacol Res ; 158: 104899, 2020 08.
Article in English | MEDLINE | ID: covidwho-1318934

ABSTRACT

SARS-CoV-2 is causing an increasing number of deaths worldwide because no effective treatment is currently available. Remdesivir has shown in vitro activity against coronaviruses and is a possible antiviral treatment for SARS-CoV-2 infection. This prospective (compassionate), open-label study of remdesivir, which was conducted at Luigi Sacco Hospital, Milan, Italy, between February 23 and March 20, 2020, involved patients with SARS-CoV-2 pneumonia aged ≥18 years undergoing mechanical ventilation or with an oxygen saturation level of ≤94 % in air or a National Early Warning Score 2 of ≥4. The primary outcome was the change in clinical status based on a 7-category ordinal scale (1 = not hospitalised, resuming normal daily activities; 7 = deceased). The 35 patients enrolled from February 23 to March 20, 2020, included 18 in intensive care unit (ICU), and 17 in our infectious diseases ward (IDW). The 10-day course of remdesivir was completed by 22 patients (63 %) and discontinued by 13, of whom eight (22.8 %) discontinued because of adverse events. The median follow-up was 39 days (IQR 25-44). At day 28, 14 (82.3 %) patients from IDW were discharged, two were still hospitalized and one died (5.9 %), whereas in ICU 6 (33.3 %) were discharged, 8 (44.4 %) patients died, three (16.7 %) were still mechanically ventilated and one (5.6 %) was improved but still hospitalized. Hypertransaminasemia and acute kidney injury were the most frequent severe adverse events observed (42.8 % and 22.8 % of the cases, respectively). Our data suggest that remdesivir can benefit patients with SARS-CoV-2 pneumonia hospitalised outside ICU where clinical outcome was better and adverse events are less frequently observed. Ongoing randomised controlled trials will clarify its real efficacy and safety, who to treat, and when.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Betacoronavirus , Compassionate Use Trials/statistics & numerical data , Coronavirus Infections/drug therapy , Hospitalization/statistics & numerical data , Intensive Care Units/statistics & numerical data , Pneumonia, Viral/drug therapy , Acute Kidney Injury/chemically induced , Adenosine Monophosphate/adverse effects , Adenosine Monophosphate/therapeutic use , Aged , Alanine/adverse effects , Alanine/therapeutic use , Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , COVID-19 , Coronavirus Infections/blood , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/blood , SARS-CoV-2 , Transaminases/blood , Treatment Outcome
18.
Ther Drug Monit ; 43(4): 455-458, 2021 08 01.
Article in English | MEDLINE | ID: covidwho-1305444

ABSTRACT

ABSTRACT: In this article, we present a case of apixaban elimination prolonged by 450% in a patient with coronavirus disease 2019 because of multiple conditions, including drug-drug interaction, severe inflammation, and acute kidney injury. Therapeutic drug monitoring was used to explain unusual routine coagulation assays. This grand round highlights the importance of dialog between the clinician and a therapeutic drug monitoring consultant for optimal patient care.


Subject(s)
Acute Kidney Injury/metabolism , COVID-19/metabolism , Drug Monitoring/methods , Pyrazoles/metabolism , Pyridones/metabolism , Renal Elimination/drug effects , Teaching Rounds/methods , Acute Kidney Injury/chemically induced , Acute Kidney Injury/prevention & control , Aged, 80 and over , Antiviral Agents/adverse effects , Antiviral Agents/metabolism , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Drug Interactions/physiology , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/metabolism , Factor Xa Inhibitors/therapeutic use , Humans , Inflammation/chemically induced , Inflammation/metabolism , Inflammation/prevention & control , Male , Pyrazoles/adverse effects , Pyrazoles/therapeutic use , Pyridones/adverse effects , Pyridones/therapeutic use , Renal Elimination/physiology , Severity of Illness Index , Time Factors
19.
Am J Kidney Dis ; 78(4): 607-610, 2021 10.
Article in English | MEDLINE | ID: covidwho-1301195

ABSTRACT

We report a case of minimal change disease (MCD) with severe acute kidney injury (AKI) following the first injection of the ChAdOx1 nCoV-19 (AZD1222) vaccine from Oxford-AstraZeneca against coronavirus disease 2019 (COVID-19). A 71-year-old man with a history of dyslipidemia and a baseline serum creatinine of 0.7mg/dL presented with nephrotic syndrome, AKI, and severe hypertension 13 days after receiving the Oxford-AstraZeneca vaccine. Refractory hyperkalemia and hypervolemia with oligoanuria prompted initiation of hemodialysis. His serum albumin was 2.6g/dL and his urinary protein-creatinine ratio was 2,321mg/mmol. Given a high suspicion for rapidly progressive glomerulonephritis, empirical glucocorticoid treatment was initiated (3 methylprednisolone pulses followed by high-dose prednisone). A kidney biopsy showed MCD and acute tubular injury. Kidney function and proteinuria subsequently improved, and hemodialysis was discontinued 38 days after the start of therapy. This case describes de novo MCD after the Oxford-AstraZeneca vaccine. It adds to the few published case reports of MCD after the Pfizer-BioNTech COVID-19 vaccine. Further reports and studies will be needed to elucidate whether MCD is truly associated with COVID-19 vaccination.


Subject(s)
Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , COVID-19 Vaccines/adverse effects , Nephrosis, Lipoid/chemically induced , Nephrosis, Lipoid/diagnosis , Severity of Illness Index , Acute Kidney Injury/complications , Aged , Humans , Male , Nephrosis, Lipoid/complications
20.
J Gen Intern Med ; 36(11): 3487-3496, 2021 11.
Article in English | MEDLINE | ID: covidwho-1260608

ABSTRACT

BACKGROUND: Black individuals have been disproportionately affected by the coronavirus disease 2019 (COVID-19). However, it remains unclear whether there are any biological factors that predispose Black patients to COVID-19-related morbidity and mortality. OBJECTIVE: To compare in-hospital morbidity, mortality, and inflammatory marker levels between Black and White hospitalized COVID-19 patients. DESIGN AND PARTICIPANTS: This single-center retrospective cohort study analyzed data for Black and White patients aged ≥18 years hospitalized with a positive SARS-CoV-2 PCR test between March 1, 2020, and August 4, 2020. MAIN MEASURES: The exposure was self-identified race documented in the medical record. The primary outcome of was in-hospital death. Secondary outcomes included intensive care unit admission, hospital morbidities, and inflammatory marker levels. KEY RESULTS: A total of 1,424 Black and White patients were identified. The mean ± SD age was 56.1 ± 17.4 years, and 663 (44.5%) were female. There were 683 (48.0%) Black and 741 (52.0%) White patients. In the univariate analysis, Black patients had longer hospital stays (8.1 ± 10.2 vs. 6.7 ± 8.3 days, p = 0.011) and tended to have higher rates of in-hospital death (11.0% vs. 7.3%), myocardial infarction (6.9% vs. 4.5%), pulmonary embolism (PE; 5.0% vs. 2.3%), and acute kidney injury (AKI; 39.4% vs. 23.1%) than White patients (p <0.05). However, after adjusting for potential confounders, only PE (adjusted odds ratio [aOR] 2.07, 95% CI, 1.13-3.79) and AKI (aOR 2.16, 95% CI, 1.57-2.97) were statistically significantly associated with Black race. In comparison with White patients, Black patients had statistically significantly higher peak plasma D-dimer (standardized ß = 0.10), erythrocyte sedimentation rate (standardized ß = 0.13), ferritin (standardized ß = 0.09), and lactate dehydrogenase (standardized ß = 0.11), after adjusting for potential confounders (p<0.05). CONCLUSIONS: Black hospitalized COVID-19 patients had increased risks of developing PE and AKI and higher inflammatory marker levels compared with White patients. This observation may be explained by differences in the prevalence and severity of underlying comorbidities and other unmeasured biologic risk factors between Black and White patients. Future research is needed to investigate the mechanism of these observed differences in outcomes of severe COVID-19 infection in Black versus White patients.


Subject(s)
Acute Kidney Injury , COVID-19 , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Adolescent , Adult , Aged , Female , Hospital Mortality , Hospitalization , Humans , Inflammation/epidemiology , Middle Aged , Retrospective Studies , Risk Factors , SARS-CoV-2
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