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Introduction: Paxlovid (nirmatrelvir/ritonavir) is a novel, orally administered COVID-19 therapeutic with a reported dysgeusia incidence of 5.6%, based on the initial clinical trial. The purpose of this study is to report the incidence and associated factors of this adverse event following the emergency use authorization of Paxlovid in December 2021, compared with other COVID-19 therapeutics (OCTs), using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Method(s): This retrospective study investigated Paxlovidassociated adverse events (PAE) and OCT adverse events queried from the FAERS database between December 1, 2021, to June 10, 2022. Descriptive statistics were performed on PAE demographic data as well as all causes of dysgeusia. Comparisons of dysgeusia incidence between Paxlovid and OCT were reported using odds ratio, Fischer exact test, and multivariate analyses. Result(s): A total of 6735 PAE and 4251 OCT adverse events were included. Paxlovid accounted for 39.4% of all medication- associated dysgeusia (n=675) between January and March 2022. Paxlovid-associated dysgeusia (PAG) was the most common PAE, with an incidence of 24.84%. PAG was associated with nonserious COVID-19 outcomes (odds ratio [OR]=4.449) and female gender (OR= 1.6), both P<.0001. Compared with OCT, Paxlovid was 12 times more likely to be associated with dysgeusia (OR=12.03;P<.0001). Conclusion(s): Our findings support a strong association between Paxlovid and dysgeusia using a real-world pharmacovigilance database. Specifically, PAG is a highly prevalent occurrence that may be particularly unique to this COVID-19 therapeutic, as compared with others. Gender may also be associated with this event. Additional studies are needed to elucidate the precise mechanism of this common adverse effect.
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SESSION TITLE: Management of COVID-19-Induced Complications SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 1:45 pm INTRODUCTION: Anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-AV) is an autoimmune mediated inflammation of small and medium sized vessel walls. The occurrence of this autoimmune vasculitis is typically associated with underlying infection, medications, and genetic predisposition.(1) The objective of this case report is to describe a rare presentation of ANCA-AV in the setting of COVID-19 infection. CASE PRESENTATION: A 67-year-old male presented to the hospital with a three-week history of cough productive of brown sputum, epistaxis, fatigue, decreased appetite, and unintentional weight loss. During the previous week, he experienced worsening dyspnea and bilateral lower extremity swelling. On physical examination, he was hypoxic requiring 4L of supplemental oxygen to maintain saturations greater than 90%. Diffuse and bilateral wheezes were heard on auscultation of his lungs. A tender petechial rash was dispersed over his limbs, trunk, oropharynx, and nasopharynx. A basic metabolic panel revealed a mild, acute renal impairment. Urinalysis showed new onset proteinuria and hemoglobinuria. Nasopharyngeal swab was positive for SARS-COV-2. Contrast-enhanced computed tomography of the chest revealed diffuse, bilateral ground glass opacities and interstitial changes. Therapy with piperacillin-tazobactam was started for presumed superimposed bacterial community acquired pneumonia in the setting of COVID-19 infection. On day three of hospitalization, the petechial rash progressed to hemorrhagic blisters. His oral petechiae were now ulcerated. A punch biopsy of the affected skin showed leukocytoclastic vasculitis. Anti-Proteinase 3 (PR3) antibodies were positive. Subsequent renal biopsy showed pauci-immune focal necrotizing crescentic glomerulonephritis consistent with ANCA-AV. Therapy with intravenous pulse dose corticosteroids led to improvement in his rash and body aches, and he was discharged home on oral steroids ten days after admission. DISCUSSION: This report describes a rare case of ANCA-AV in the setting of recent COVID-19 infection. Differentiation of ANCA-AV, bacterial and COVID-19 pneumonia can be challenging on chest imaging alone.(1) New onset renal impairment, hematuria, proteinuria and the presence of the petechial rash were suspicious for co-existing ANCA-AV in this patient. COVID-19- associated cytokine storm and formation of neutrophil extracellular traps (NETs) is postulated to be the underlying cause.(1-3) NETs present myeloperoxidase (MPO) and PR3 antigens to the immune system. Formation of auto-antibodies to MPO and PR3 lead to the development of ANCA-AV. The findings of NETs on kidney biopsy specimens in patients with ANCA-AV supports this hypothesis.(1,2) CONCLUSIONS: To avoid the misdiagnosis of COVID-19-induced vasculitis, a low threshold to investigate co-existing vasculitis in patients with COVID-19 and associated clinical findings is highly recommended. Reference #1: Izci Duran T, Turkmen E, Dilek M, Sayarlioglu H, Arik N. ANCA-associated vasculitis after COVID-19. Rheumatol Int. 2021;41(8):1523-1529. Reference #2: Uppal NN, Kello N, Shah HH, et al. De Novo ANCA-Associated Vasculitis With Glomerulonephritis in COVID-19. Kidney Int Rep. 2020;5(11):2079-2083. Reference #3: Cobilinschi C, Cobilinschi C, Constantinescu A, Draniceanu I, Ionescu R. New-Onset ANCA-Associated Vasculitis in a Patient with SARS-COV2. Balkan Med J. 2021;38(5):318-320. DISCLOSURES: No relevant relationships by Andrei Hastings No relevant relationships by Jason Lane No relevant relationships by Tanya Marshall No relevant relationships by Palak Rath No relevant relationships by Sterling Shriber No relevant relationships by inderprit Singh No relevant relationships by Samuel Wiles
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Background: Patients requiring extracorporeal membrane oxygenation (ECMO) frequently necessitate tracheostomy due to prolonged mechanical ventilation. SARS-CoV-2 infection has been associated with different coagulation disorders and may increase the risk of bleeding in high risk patients such as those requiring ECMO. Here, we aim to determine if SARS-CoV-2 increases the risk of bleeding after tracheostomy in ECMO patients. Methods: A retrospective review of all patients requiring ECMO at our institution between March 20 of 2020 and December 31 of 2021 was conducted. Patients requiring tracheostomy after ECMO were included. Demographics, COVID-19 status, tracheostomy approach and post-procedure bleeding events were collected. Statistical analysis was performed using student T-test for nominal variables and Chi-Square test for categorical variables. Results: A total of 267 patients required ECMO during the defined study period. Of these, 112 patients had tracheostomy placement and were included for analysis. Seventy-five percent (84/112) of tracheostomies were done percutaneously and 25% (28/112) were done using surgical open technique. Mean age was 46.2 years ±14.3, 68% were male, mean BMI was 29.9Kg/m2 ±5.5. Seventy patients (63%) had COVID-19. The remaining 42 (37%) required ECMO due to polytrauma, cardiogenic shock, and respiratory failure after other operations such as heart and lung transplant. Of the 112 tracheostomies performed, 34% (38/112) had severe bleeding after tracheostomy placement requiring blood transfusion or additional interventions to control the bleeding. Of the 70 patients with COVID-19, 47% had severe bleeding compared to 12% in the non-COVID-19 group (p=<0.001) (Table). Conclusion: The rate of severe bleeding after tracheostomy was significantly higher in patients with COVID-19 compared with those that did not have SARS-CoV-2 infection. COVID-19 status should be considered before tracheostomy in ECMO patients as it may increase the risk of bleeding complications (Table Presented).
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Objectives:Trends in the extent of cannabis use in the total population and increased cannabis use and number of days of cannabis use among those who used cannabis were characterized over an 11-month period during the novel coronavirus disease pandemic in Canada.Methods:Data were obtained from a national web-based, cross-sectional survey of adults who spoke English and resided in Canada, which was repeated at seven time points between May 8, 2020 and March 23, 2021 (n = 7021). Participants provided self reports of cannabis use, increased cannabis use, and number of days of cannabis use. For outcomes where a significant trend was observed, changes within demographic subgroups were further explored to identify differential patterns of change. Trends were assessed using Cochrane Armitage Test and Kruskal-Wallis Test.Results:Cannabis use rose from 11.5% at Wave 1 to 14.1% at Wave 7 (P = 0.017). A similar trend within demographic subgroups was not observed, suggesting an absence of differential patterns of change. No changes were found among those who used cannabis in regards to increased cannabis use since before the pandemic (55.7% at Wave 1 to 49.7% at Wave 7;P = 0.614) and the number of days of cannabis use (4.0 days at Wave 1 to 4.0 days at Wave 7;P = 0.878).Conclusions:Given that more people reported cannabis use, and about half of those who used cannabis increased cannabis use, evidence-based policies and interventions are needed to ensure minimal transition to near daily or daily cannabis use.
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Background: Acute kidney injury (AKI) is common in critically ill patients receiving extracorporeal membrane oxygenation (ECMO). Use of continuous renal replacement therapy (CRRT) with ECMO may help optimize fluid balance and correct electrolyte abnormalities but may also worsen outcomes. The relationship between AKI, CRRT, and survival in ECMO patients remains poorly defined. The aim of this study was to evaluate AKI outcomes in the setting of ECMO support. We assessed factors that may influence AKI severity, as well as the safety of combined CRRT with ECMO Methods: We performed a retrospective analysis of patients that received ECMO from 2018-2021 at a tertiary hospital, using a prospectively maintained database. All patients requiring CRRT received continuous veno-venous hemodiafiltration (CVVHDF). Data collected includes demographics, ECMO and CRRT parameters, anticoagulation, baseline kidney disease, baseline serum creatinine (sCr), ECMO and CRRT duration, hospital length of stay (LOS), complications (patient and device-related), and outcomes. Results: To date, 16 ECMO patients with AKI have been analyzed. Mean age was 46.6 +/-15.6 years. Eleven (68%) were male, and 50% were African American. ECMO indication included respiratory failure due to COVID-19 (43%), followed by respiratory failure from sepsis (19%). Initial ECMO modality was VV-in 75% and VA-in 25%. Mean baseline sCr and sCr at CRRT initiation were 1.3+/-1 mg/dL and 3.93+/-1.1 mg/dL, respectively. Mean ECMO duration was 30+/-37 days, and mean CRRT duration was 26+/-21 days. Elevated plasma hemoglobin (mean peak 103 mg/dL) levels occurred in 14 (88%) patients. Of 10 (63%) patient surviving to discharge, 3 (30%) were dialysis dependent. sCr at CRRT start did not influence CRRT duration: for sCr<4 mg/dL, mean CRRT duration was 37 days, and for sCr>4 mg/dL, mean CRRT duration was 20 days (p=0.21). Mean creatinine at discharge was 1.78+/-1.1 mg/dL. Conclusions: Our results suggest that CRRT can be safely combined with ECMO to achieve satisfactory patient outcomes. Dialysis independence seems attainable in most patients;however, additional patient enrollment is underway to support this concept with a greater degree of confidence.