Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case–noncase study

Chouchana, Laurent; Préta, Laure-Hélène; Tisseyre, Mylène; Terrier, Benjamin; Tréluyer, Jean‐Marc; Montastruc, François

doi:10.1016/j.kint.2021.02.015

Cited by 24 publications

(26 citation statements)

References 4 publications

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“…The use of Remedesivir led to deranged kidney and liver functions. A similar causal association between Remedesivir and kidney disorders has also been reported byChouchana et al (2021) [16]. Majority of ADRs in this study presented as rash and urticaria.…”

supporting

confidence: 90%

“…With the evolving knowledge on the pathophysiology of the disease, drug regimens are constantly being updated and modi ed, adding more numbers to the existing list of drugs being used, especially in severe cases.Hydroxychloroquine, Ivermectin, Doxycycline, Favipiravir and multivitamins were recommended for treatment of mild (to moderate) category COVID patients. Convalescent Plasma therapy, anti-in ammatory drugs (such as methylprednisolone or dexamethasone), antivirals, immunomodulators, anticoagulants (UFH or LMWH), thiamine, vitamin C and antimicrobials and or antifungals as per local antibiotic policy were recommended for COVID-19 patients who progressed to the in ammatory phase (moderate/ severe category) of the disease [1]. While the occurrence of adverse drug reactions (ADRs) in COVID 19 patients has not been extensively studied, ndings from retrospective trials in non-COVID cases indicate that it is likely to be high [2][3].…”

Section: Introductionmentioning

confidence: 99%

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Adverse Drug Reactions in COVID-19 patients admitted to Intensive care unit: Analysis of individual case study reports

Nazir

Chopra

Sidhu

et al. 2021

Preprint

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Background Occurrence of adverse drug reactions in COVID-19 patients has not been extensively studied. Thus the present study was conducted to analyze the pattern of suspected Adverse Drug Reactions in COVID-19 patients admitted in Intensive Care Unit. Methods In this observational study, all the individual case study reports of patients admitted to the COVID ICU from August to October 2020 were analyzed. The type of ADR, the system involved, drug history, the suspected drug, reaction time and time to revert and management of ADR were recorded. ADRs were classified as serious and non-serious and causality was assessed using the WHO-UMC scale. The severity of ADRs was determined using Hartwig Scale. Results From 395 patients admitted to the COVID ICU during the study period, 44 individual case reports were received of 36 patients. Dermatological manifestations were the most frequent ADRs reported in this study, followed by gastrointestinal. Remedesivir was the most common drug associated with ADRs. The female gender, use of more than 5 drugs and presence of comorbidities were the independent risk factors for the occurrence of ADRs in patients with COVID-19. Conclusion The use of many of these drugs in this pandemic is experimental and so far the data available in the literature does not guarantee the safety and efficacy for COVID-19 treatment. Therefore, during these times of uncertainty, the results from present study reinforce the importance of monitoring patients. Early diagnosis and management of ADRs is warranted.

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supporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Adverse Drug Reactions in COVID-19 patients admitted to Intensive care unit: Analysis of individual case study reports

Nazir

Chopra

Sidhu

et al. 2021

Preprint

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“…Two analyses of the World Health Organization pharmacovigilance database have identified that reports of AKI are more commonly reported after remdesivir use compared to other medications used to treated COVID-19 (hydroxycholoroquine, dexamethasone, tocilizumab) [31,32]; however reporting bias exists in pharmacovigilance databases.…”

Section: Discussionmentioning

confidence: 99%

A Propensity Score–Matched Observational Study of Remdesivir in Patients with COVID-19 and Severe Kidney Disease

et al. 2022

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Background: Remdesivir is not currently approved for patients with estimated glomerular filtration rate (eGFR) < 30mL/min/1.73m2. We aimed to determine the safety of remdesivir in patients with kidney failure. Methods: Retrospective cohort study of patients with COVID-19 hospitalized between May 2020 to January 2021 with eGFR <30 mL/min/1.73m2 who received remdesivir and historical controls with COVID-19 hospitalized between March 1, 2020 - April 30, 2020 prior to Emergency Use Authorization of remdesivir within a large healthcare system. Patients were 1:1 matched by propensity scores accounting for factors associated with treatment assignment. Adverse events and hospital outcomes were recorded by manual chart review. Results: The overall cohort included 34 hospitalized patients who initiated remdesivir within 72 hours of hospital admission with eGFR <30 mL/min/1.73m2 and 217 COVID-19 controls with eGFR <30 mL/min/1.73m2. The propensity score-matched cohort included 31 remdesivir treated cases and 31 non-remdesivir-treated controls. The mean age was 74.0 (SD: 13.8), 56.6% female, 67.7% white. A total of 25.5% had end-stage kidney disease. Among patients who were not on dialysis prior to initiating remdesivir, one developed worsening kidney function (defined ≥ 50% increase in creatinine or initiation of kidney replacement therapy) compared to three in the historical control group. There was no increased risk of cardiac arrythmia, cardiac arrest, altered mental status, or clinically significant anemia or liver function test abnormalities. There was a significantly increased risk of hyperglycemia, which may be partly explained by the increased use of dexamethasone in the remdesivir-treated population. Conclusion: In this propensity-score matched study, remdesivir was well tolerated in patients with eGFR < 30 mL/min/1.73m2.

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“…The nucleotide analogue prodrug remdesivir was granted emergency use authorization (EUA) for the treatment of COVID-19 in May 2020 for its ability to inhibit viral RNA-dependent RNA polymerase (59). While studies have shown that remdesivir treatment in AKI and CKD patients is tolerated well, the active metabolite of remdesivir is eliminated by the kidneys and has been reported to increase chances of developing AKI in remdesivir-treated patients (60)(61)(62). To investigate the efficacy of remdesivir, we infected kidney organoids with SARS-CoV-2 (WA1) or SARS-CoV-2-mNG, and then treated the infected organoids with a 2 µM dose of remdesivir immediately after infection (Figure 6A).…”

Section: Therapeutics Reduce Sars-cov-2 Infection and Replication In Kidney Organoidsmentioning

confidence: 99%

Cross-validation of SARS-CoV-2 responses in kidney organoids and clinical populations

Helms¹,

Marchianò²,

Stanaway³

et al. 2021

JCI Insight

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Kidneys are critical target organs of COVID-19, but susceptibility and responses to infection remain poorly understood. Here, we combine SARS-CoV-2 variants with genome-edited kidney organoids and clinical data to investigate tropism, mechanism, and therapeutics. SARS-CoV-2 specifically infects organoid proximal tubules among diverse cell types. Infections produce replicating virus, apoptosis, and disrupted cell morphology, features of which are revealed in the context of polycystic kidney disease. Cross-validation of gene expression patterns in organoids reflects proteomic signatures of COVID-19 in the urine of critically ill patients indicating interferon pathway upregulation. SARS-CoV-2 viral variants alpha, beta, gamma, kappa, and delta exhibit comparable levels of infection in organoids. Infection is ameliorated in ACE2–/– organoids and blocked via treatment with de novo–designed spike binder peptides. Collectively, these studies clarify the impact of kidney infection in COVID-19 as reflected in organoids and clinical populations, enabling assessment of viral fitness and emerging therapies.

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Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case–noncase study

Cited by 24 publications

References 4 publications

Adverse Drug Reactions in COVID-19 patients admitted to Intensive care unit: Analysis of individual case study reports

Adverse Drug Reactions in COVID-19 patients admitted to Intensive care unit: Analysis of individual case study reports

A Propensity Score–Matched Observational Study of Remdesivir in Patients with COVID-19 and Severe Kidney Disease

Cross-validation of SARS-CoV-2 responses in kidney organoids and clinical populations

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