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1.
Research and Practice in Thrombosis and Haemostasis Conference ; 6(Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2128204

ABSTRACT

Background: Subcutaneous desmopressin (DDAVP) can be more easily administered than intravenous DDAVP and may be an efficacious alternative for the currently unavailable intranasal DDAVP to treat mild bleedings or for minor invasive procedures in von Willebrand disease (VWD) and hemophilia A. Aim(s): To compare the one-hour response to subcutaneous and intravenous DDAVP in patients with VWD or hemophilia A. Method(s): Patients with hemophilia A (FVIII <=10 IU/dl) or VWD (VWF activity <=10 IU/dl) whose treatment plans include DDAVP and who were to receive a COVID-19 vaccination were eligible to participate. For COVID-19 vaccination, FVIII or VWF activity target levels of >10 IU/dl were pursued according to international guidelines (ISTH). DDAVP was administered subcutaneously 1.5 h before vaccination. FVIII (in hemophilia and VWD) and VWF activity levels (in VWD) were determined prior to (t = 0) and 1 h after DDAVP (t = 1). All patients had a positive historical routine challenge test with intravenous DDAVP. For each participant, absolute and relative changes of FVIII and VWF activity levels 1 h after subcutaneous and intravenous DDAVP (both 0.3 mug/kg) were compared. Result(s): Eleven patients were included: Six with hemophilia A, three with VWD type 2M and two with VWD type 2A. Both intravenous and subcutaneous DDAVP increased FVIII and VWF activity levels in all patients. In hemophilia patients, intravenous and subcutaneous DDAVP increased FVIII levels by an average of 3.8-fold and 3.4-fold respectively. Peak FVIII activity levels at t = 1 ranged from 25-62 IU/ dl and 29-51 IU/dl. In VWD patients, intravenous and subcutaneous DDAVP was associated with a 11.4-fold and 5.1-fold mean increase in VWF activity levels respectively. Corresponding peak VWF activity levels ranged from 18-100 IU/dl and 28-74 IU/dl. No bleeding after vaccination was reported. Conclusion(s): Subcutaneous DDAVP appears to be an effective alternative for intravenous DDAVP. Moreover, like intranasal DDAVP, subcutaneous DDAVP allows the possibility of self-administration at home.

2.
Research and Practice in Thrombosis and Haemostasis Conference ; 6(Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2128083

ABSTRACT

Background: Severe COVID-19 is associated with platelet activation, thrombosis, and thrombocytopenia, but the mechanisms remain unclear. Similarly, very rare cases of COVID-19 vaccine-induced-thrombotic-thrombocytopenia (VITT) are also poorly understood. Both infection and vaccination utilize the receptor-binding domain (RBD) of the spike protein for virus-host cell entry and to elicit an immune response, respectively. Interestingly, the RBD contains an RGD integrin-binding motif that may facilitate platelet binding. Aim(s): To determine whether the RBD binds platelets and causes platelet activation/clearance. Method(s): We intravenously injected different doses (0.25, 0.5, 1.0mug/g) of recombinant RBD into mice and measured platelet counts post-injection using a Z2 Series Coulter. Flow cytometry detected RBD/RBD variants binding to platelets and associated platelet activation, apoptosis, and desialylation. Human gel-filtered platelet aggregation was induced by ADP, Collagen and Thrombin. Six anti-RBD monoclonal antibodies (mAbs) were generated and tested in a SARS-CoV-2 Vero cell infection model with the envelop gene quantified by RT-qPCR to determine the virus replication. Result(s): RBD injection caused platelet clearance in a dose-dependent manner. The RBD could also bind to platelets, induce activation and potentiate platelet aggregation in vitro. Our preliminary data also showed the RBD Delta variant has greater potential in inducing platelet activation. Interestingly, the RBD bound beta3-/-platelets ~50% less relative than wildtype mice. Consistently, mutating the RGD motif to RGE, and preincubating platelets with the beta3 inhibitor Eptifibatide also reduced RBD binding to platelets. Our novel anti-RBD mAbs 4F2 and 4H12 inhibited RBD-induced platelet activation and RBD-potentiated platelet aggregation in vitro, and prevented RBD-induced platelet clearance in vivo. Importantly, these mAbs also inhibited SARS-CoV-2 viral replication in a dose-dependent manner. Conclusion(s): Our data demonstrate that the RBD could directly bind to platelets partially via beta3 integrin. RBD-induced platelet activation and clearance may contribute to thrombosis and thrombocytopenia observed in clinical cases of COVID-19 and VITT.

3.
Journal of Vascular Access ; 23(1 Supplement):31-32, 2022.
Article in English | EMBASE | ID: covidwho-2114397

ABSTRACT

Introduction: INCATIV is a research program carried out by nurses on 34 hospitals of the Region of Valencia (Spain). This program measures vascular access quality on patients of these hospitals via cross-sections. The objective of the study is to evaluate the influence of COVID-19 pandemic in the registers of the vascular accesses' quality program. Method(s): Quantitative observational, analytical, and retrospective study of two cross-sections. First cross-section was developed before pandemic (C10: 02-2020) and second cross-section during pandemic (C11: 05-2020). Data was obtained from INCATIV's platform. Result(s): Among 34 participant hospitals in INCATIV Program, there was a 100% of participation at C10, collecting 7647 registers of all hospital units included at the program. 4820 vascular accesses were evaluated. Only a 1.22% of them presented signs of phlebitis. 92% of the vascular accesses had the right dressing. At C11, there was a 50% of participation. 3234 registers were collected. Phlebitis rate remains at 1.15%. The use of correct dressing reached at 92% too. Discussion and conclusion: Data indicate a strong decrease in the number of participating hospitals as on the number of registers of this quality program focused on intravenous therapy, confirming the existence of changes in the trend of the registers, in the absence or presence of pandemic moments. On the other hand, it is observed that there are no statistically significant differences related to the quality of the vascular accesses, showing that two main indicators measured, included at INCATIV bundle, such as type of dressing and signs of phlebitis, remain constant despite being measured at two different pandemic moments. Further studies are necessary about how vascular accesses nursing care has changed only in COVID-19 patients.

4.
Neurology Asia ; 27(3):783-786, 2022.
Article in English | EMBASE | ID: covidwho-2067763

ABSTRACT

Neutropenia during recovery after coronavirus disease 2019 (COVID-19), as well as neutropenia after intravenous immunoglobulin (IVIG) administration are very rare hematological abnormalities. We report the first case of agranulocytosis following IVIG administration in patients with Guillain-Barre syndrome (GBS) triggered by COVID-19. A 62-year-old female patient was admitted to the Emergency Department due to progressive limb weakness and sensory disturbances that began two weeks before admission. Five weeks before admission she was treated for COVID-19 and has fully recovered. She was diagnosed with Guillain-Barre syndrome (GBS), and treatment with IVIG was started. Twenty hours after the first dose of IVIG, blood analysis showed neutropenia and thrombocytopenia, and after the fifth dose she developed agranulocytosis followed by mild increase in body temperature. Granulocyte colony-stimulating factor (G-CSF) was administered and after 12 hours the leukocyte lineage recovered. According to the previous findings, neutropenia after IVIG administration might be related to CD11b, and COVID-19 is associated with an increase in immature neutrophil populations in the later stages of the disease defined by their expression of CD11b. Meanwhile, some finding suggests that corticosteroid pretreatment prevent neutropenia after IVIG administration, which might be important because many patients with post-COVID GBS have been treated with corticosteroids for COVID-19. Copyright © 2022, ASEAN Neurological Association. All rights reserved.

5.
Archives of Clinical Infectious Diseases ; 17(4), 2022.
Article in English | EMBASE | ID: covidwho-2067098

ABSTRACT

Background: The application of methylprednisolone in ARDS patients has led to a sustained reduction in inflammatory plasma cytokines and chemokines and has recently been used in the treatment of patients with SARS-CoV-2 infection. Objectives: In this study, the effect of methylprednisolone on clinical symptoms and antioxidant changes of patients with COVID-19 has been investigated. Methods: In the present study, patients with moderate to severe COVID-19 who required hospitalization were entered into the study phase. Then, in addition to standard treatment, patients received methylprednisolone at a dose of 250 mg intravenously over three days. Necessary evaluations include analysis of arterial blood gases, pulse oximetry, monitoring of patient clinical signs, examination of inflammatory biomarkers, and also receiving 10 cc of peripheral blood samples to check for antioxidant changes, at the beginning of the study, after 24 hours, and 72 hours after receiving methylprednisolone was on the agenda. Results: Changes in fever, superoxide dismutase (SOD, Glutathione-S-Transferase (GST, the ferric reducing ability of plasma (FRAP, malondialdehyde (MDA, Nitric oxide, Ferritin, and TNF-α before treatment and 72 hours after treatment were significantly different between the two stages (P < 0.05). Conclusions: The use of methylprednisolone improves the balance of antioxidants and immunological factors in patients with COVID-19 and thus improves some clinical indicators in these patients.

6.
Indian Journal of Critical Care Medicine ; 26(10):1091-1098, 2022.
Article in English | EMBASE | ID: covidwho-2066996

ABSTRACT

Background: It is known that coronavirus disease-2019 (COVID-19) pneumonia causes cytokine storm, and treatment modalities are being developed on inhibition of proinflammatory cytokines. We aimed to investigate the effects of anticytokine therapy on clinical improvement and the differences between anticytokine treatments. Method(s): A total of 90 patients with positive COVID-19 polymerase chain reaction (PCR) test were divided into three groups, group I (n = 30) was given anakinra, group II (n = 30) was given tocilizumab, and group III (n = 30) was given standard treatment. Group I was treated with anakinra for 10 days;tocilizumab, intravenously, was given in group II. Group III patients were selected from those who did not receive any anticytokine treatment other than the standard treatment. Laboratory values, Glasgow coma scale (GCS), and PaO2/FiO2 values were analyzed on days 1, 7, and 14. Result(s): The seventh-day mortality rates were 6.7% in group II, 23.3% in group I, and 16.7% in group III. In group II, the ferritin levels on the 7th and 14th days were significantly lower (p = 0.004), and the lymphocyte levels on the seventh day were significantly higher (p = 0.018). Examining the changes between the first intubation days, in the early period (seventh day), group I was found to be 21.7%, group II was 26.9%, and group III was 47.6%. Conclusion(s): We observed the positive effects of the use of tocilizumab on clinical improvement in the early period;mechanical ventilation requirement was delayed and at a lower rate. Anakinra treatment did not change mortality and PaO2/FiO2 rates. Mechanical ventilation requirements occurred earlier in the patients who were not receiving any anticytokine therapy. Studies with larger patient populations are needed to demonstrate the potential efficacy of anticytokine therapy. Copyright © The Author(s).

7.
Anti-Infective Agents ; 20(4) (no pagination), 2022.
Article in English | EMBASE | ID: covidwho-2065291

ABSTRACT

Mucormycosis is the most emerging angioinvasive fungal infection of filamentous fungi of the Zygomycetes class, which, when neglected, causes severe disseminated infection along with significant chances of morbidity and mortality. The diagnosis and treatment remain challenging for the doctors. It has been observed that people who have been suffering from different diseases, such as hematological malignancies and uncontrolled diabetes, or who have gone through different surgeries, such as hemato-poietic stem cell transplant, and solid transplantation, are the most affected ones. On the other hand, people who have recovered from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) typically show the symptoms of mucormycosis after 1-2 weeks of successful recovery. Standard treatment of mu-cormycosis is traditionally considered an amphotericin B intravenous (IV) drug as initial therapy, alt-hough posaconazole and isavuconazole are also used. The core objective of the review is to typically focus on the area of the sudden cause of mucormycosis in the patients who have already recovered from SARS-CoV-2. Copyright © 2022 Bentham Science Publishers.

8.
Otolaryngology - Head and Neck Surgery ; 167(1 Supplement):P284-P285, 2022.
Article in English | EMBASE | ID: covidwho-2064422

ABSTRACT

Introduction: A patient with progressive rhino-orbito-cerebral mucormycosis (ROCM) despite maximal therapy survived 2 months after complete discontinuation of treatment. A 35-year-old man with poorly controlled diabetes presented to outside hospital with severe headaches, cough, and hyperglycemia. He was found to be COVID-19 positive and in severe diabetic ketoacidosis. He received neither corticosteroids nor monoclonal antibodies for COVID-19. Empiric therapy with intravenous (IV) antibiotics, antivirals, and antifungals was initiated. Endoscopic sinus debridement revealed fungal invasion;pathology confirmed mucormycosis. Subsequent imaging showed disease progression with intracranial extension despite maximal treatment. The patient elected to stop all treatment and was discharged with home hospice. He continued only metformin and did not make a concerted effort toward glycemic control. After 2 months he presented to Loma Linda Hospital with right eye symptoms;imaging showed persistent disease. IV antibiotics and antifungals were initiated. After endoscopic evaluation and debridement, tissue pathology showed residual mucormycosis. The patient was discharged home after 16 days with a 6-week course of meropenem and lifelong posaconazole. Method(s): A PubMed search for English-language case reports and series from 2000 to present was performed using search terms mucormycosis, survive, rhino-orbitocerebral, rhino-cerebral, and cerebral. Result(s): No reports of long-term survival after discontinuation of therapy were identified. Conclusion(s): This case illustrates a rare situation in which a patient whose ROCM progressed despite maximal therapy survived for over 2 months after halting treatment. ROCM mortality is as high as 85%. Outcomes are improved with surgical and antifungal therapy, and there are many reports of survival with ongoing treatment. However, there appear to be no documented cases of survival with active disease after termination of therapy. This patient's unsuccessful management and 2-month treatment hiatus make his long-term survival surprising.

9.
Otolaryngology - Head and Neck Surgery ; 167(1 Supplement):P165, 2022.
Article in English | EMBASE | ID: covidwho-2064412

ABSTRACT

Introduction: With new SARS-CoV-2 variants emerging such as Delta and Omicron, it is important to reevaluate patterns of presentation and affected patient characteristics. SARS-CoV-2 infection may be shifting from a primary insult of the lower airway to one primarily affecting the upper airway. Method(s): This is a report of a novel case of SARS-CoV-2 infection causing an epiglottic abscess during the peak of the Omicron wave. A literature review showed no previous reports of this specific entity. Result(s): An otherwise healthy, unvaccinated 25-year-old man presented with 3 days of throat pain and mild cough. He had no subjective or objective fevers, malaise, voice changes, or difficulty breathing. White blood cell count was normal. A computed tomography neck with intravenous (IV) contrast revealed edema and gas formation of the epiglottis with a small developing abscess. Flexible fiber-optic laryngoscopy showed an edematous epiglottis with prolapse posteriorly to the pharyngeal wall and mild arytenoid edema without involvement of the vocal folds. He was intubated in the operating room, and incision and drainage of the epiglottic abscess was performed. He was given steroids and broad-spectrum IV antibiotics and extubated without difficulty on postoperative day 2. Intraoperative cultures unfortunately did not speciate to guide antibiotic therapy. He continued to improve clinically and was discharged home on postoperative day 3 with a course of amoxicillin/clavulanate. Conclusion(s): This case highlights a unique presentation of COVID in a young, unvaccinated patient that was successfully managed with operative drainage. He was without any medical comorbidities or immunodeficiency. It is possible that current COVID variants have a predilection for the upper airway as evidenced by this case.

10.
Archives of Disease in Childhood ; 107(Supplement 2):A261, 2022.
Article in English | EMBASE | ID: covidwho-2064031

ABSTRACT

Aims Anakinra is an Interleukin-1 receptor (IL-1) antagonist;a biologic drug that has historically been used as part of longerterm management in methotrexate-resistant rheumatoid arthritis, cryopyrin-associated periodic syndromes and systemic juvenile idiopathic arthritis. We describe its successful use in acute multisystem inflammation in a cohort of recently treated children in a Tertiary Children's Hospital. Methods We reviewed the details of 6 acutely unwell inpatients admitted over the last 6 months, with acute multisystem inflammation, who had been treated with Anakinra as a rescue medication, following resistance to first-line anti-inflammatory medications. Five of these patients had been diagnosed with Paediatric Multisystem Inflammatory Syndrome temporarily associated with COVID-19 (PIMS). One of these patients had been diagnosed with Hemophagocytic Lymphohistiocytosis (HLH). Results The average length of initial treatment was 3.5 days before commencing Anakinra. All patients on Anakinra also received contemporaneous intravenous methylprednisolone treatment (IVMP), and 5/6 patients had received intravenous immunoglobulin therapy (IVIG). Common indications for commencing Anakinra were: persisting fevers despite at least 3 days of IVMP, and increasing inflammatory markers despite first line treatment. The average C-reactive Protein (CRP) at initiation of Anakinra was 82 (range 32 to 132) and the average Ferritin at initiation was 1500 (range 129 to 4640), with the average treatment duration of 6.7 days until CRP normalised, and all with normal CRP two weeks after treatment. All patients were started on an initial 2mg/kg dose of Anakinra, rounded up to nearest 100mg dose in most. Five patients were prescribed a subcutaneous route whilst one patient was started on an IV route. Half of patients were commenced on a once daily regime, two patients were started on a twice daily regime, and one patient was started on a QDS regime. One patient required a dose increase due to ongoing fevers after initiation. Average treatment length for the patients diagnosed with PIMS was 8.6 days, whereas treatment length was 25 days in the patient with HLH. We also describe the need for inotropic support (1/5), significant echocardiography findings at presentation (3/5) and at 2 weeks post-discharge (1/5) in this cohort of patients with PIMS. Conclusion Anakinra was successfully used as an acute treatment for our 6 described patients with multisystem inflammation. With more recent waves of PIMS, Anakinra has increasingly been used as a second-line treatment. Its introduction ceased ongoing fevers in all patients;5 of 6 with immediate effect. There are some clear advantages of Anakinra as a rescue drug over other potential biological alternatives, namely;choice of preparation, tolerability and few described side effects with short-term use. We highlight the experiential effectiveness of the acute use of Anakinra in our cohort of children with hyperinflammation, and recommend its accessibility as an emergency drug.

11.
Archives of Disease in Childhood ; 107(Supplement 2):A203-A204, 2022.
Article in English | EMBASE | ID: covidwho-2064028

ABSTRACT

Aims Multisystem inflammatory syndrome in children (MIS-C) secondary to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has affected not only the older children, adolescents and adults but also infants, more so during the second wave of the global pandemic. Thus, this study was done to describe the profile of infants presenting with multisystem inflammatory syndrome (MIS) with the aim to alert clinicians regarding the need for its early diagnosis and timely management in this vulnerable age group to prevent the morbidity, mortality and long term complications associated with MIS-C. Methods All sequentially admitted infants hospitalized during a period of 6months from,who fulfilled the WHO/CDC/RPCH criteria for MIS-C were included in the study. The data was recorded in a semi-structured pre-tested self-designed proforma regarding the demographic profile, presenting symptoms, clinical signs, laboratory parameters and treatment received. The data was analysed using appropriate statistical tools. Results A total of 19 infants were studied. Of these, 68.3% (13) had an evidence of recent COVID-19 infection. The median age of presentation was 2 months. The male:female ratio was 1.1:1. The most common presenting symptoms were fever (68.4%), gastrointestinal complaints (63.1%) and edema (36.8%) (figure 1). Other predominant signs were shock (78.9%), myocarditis (52.6%) and neurological complaints (26.3%). Incomplete Kawasaki disease was present in 21% patients. Elevated CRP, ferritin, D-Dimer, NT pro BNP and reduced fibrinogen were markers of severe illness. All subjects received IVIG (100%), 31.5% received a second dose of IVIG and 63.1% received pulse intravenous methylprednisolone. (table 1) A total of 5(26.3%) died as a result of the disease process. Conclusion MIS-C in infants is usually under-diagnosed and under-reported due to the considerable overlap between sepsis and MIS-C especially due to the higher incidence of sepsis in developing countries. The spectrum of this illness can be varied and is different from the overt clinical signs seen in older children and adolescents. Thus, these investigations should be done early in the course for optimal therapy with immunomodulators and favourable outcome.. (Figure Presented).

12.
American Journal of Transplantation ; 22(Supplement 3):965, 2022.
Article in English | EMBASE | ID: covidwho-2063547

ABSTRACT

Purpose: Primary focal segmental glomerulosclerosis (FSGS) recurs after kidney transplantation (KT) in 30-50% of recipients with a median time of 1.5 months post- KT. Recurrence is associated with early graft loss in 60% of cases. The aim of this study is to assess the efficacy of pre-emptive therapeutic plasma exchange (TPE) and rituximab for the prevention of FSGS recurrence post-KT. Method(s): This single-center, retrospective study included patients receiving KT for primary FSGS between May 2016 and August 2021. Living-donor KT recipients received three sessions of TPE prior to scheduled transplant. Recipients of both living and deceased donor KT received 3 postoperative sessions of TPE followed by one dose of 375 mg/m2 rituximab with or without intravenous immune globulin (IVIG) 0.5 g/kg. Recipients underwent protocol biopsy at one month to screen for FSGS recurrence. The primary endpoint was a composite for disease recurrence including proteinuria (>=1 g/day) or/and biopsy-proven FSGS within one month. Result(s): 54 patients received KT for FSGS during the study period using the TPE/ rituximab protocol. 5 patients (9%) experienced FSGS recurrence within one month of transplant. A total of 10 patients (19%) were found to have disease recurrence within a year, with median (IQR) time to recurrence of 37 days (27-66). White race and history of hypertension were independent risk factors for recurrence, whereas African American race and diabetes were associated with a reduced risk of recurrence. 31 patients (57%) also received IVIG prior to discharge due to concerns for hypogammaglobulinemia. There were 18 documented infections in 13 patients (24%) within 3 months of transplant. Patients who received IVIG had significantly fewer cases of infection (3 cases: 1 viral and 2 COVID-19) compared to patients who did not receive IVIG (15 cases: 4 bacterial, 9 viral, 1 fungal, and 1 COVID-19), p<0.001. At one year, 9 patients (19%) had biopsy-proven rejection (5 acute cellular rejection, 1 antibody-mediated rejection, and 3 mixed rejection). There were no instances of graft loss or mortality observed at one year. Conclusion(s): The utilization of plasma exchange and rituximab may prevent early disease recurrence of FSGS without significant rates of infection, graft loss, or mortality.

13.
American Journal of Transplantation ; 22(Supplement 3):992, 2022.
Article in English | EMBASE | ID: covidwho-2063425

ABSTRACT

Purpose: Lung transplant is the last resort for COVID-19 refractory ARDS. Dual organ transplant is seen as a relative contraindication at many institutions. We describe a case of simultaneous Lung-Kidney transplant (SLK) in a patient with COVID-19 ARDS. Method(s): A 24-year-old patient with no PMH presented to an outside hospital with a week of shortness of breath, cough, and fever. Despite treatment with Remdesivir and dexamethasone, the patient developed hypoxemic respiratory failure with acute renal injury requiring ICU care and intubation, V-V ECMO, and dialysis. Additionally, Intravenous and inhaled Aviptadil were given under emergency use authorization. While oxygenation improved, the patient could not be weaned off ECMO. With a LAS score of 90.29, the patient underwent an SLK transplant on HD 53, requiring standard induction and maintenance immunosuppression therapy. The patient was treated post-operatively for PGD as well as for subclinical AMR. After successful inpatient rehabilitation, the patient was discharged home after four months and had a one-month follow-up on room air and normal creatinine clearance. Result(s): Patients with pre-existing renal dysfunction who have undergone lung transplants have a significantly higher one- and three-year mortality than patients with normal GFR. The patient's survival after SLK was similar to isolated lung transplants at one and five years, according to an analysis of the UNOS/OPTN database. Still, dual organ transplant in the COVID-19 ARDS population is considered a contraindication at many centers, given these patients' critical illness and frailty. However, the frailty in this population is reversible due to the rapid onset of disease in an otherwise previously healthy younger population with minimal comorbidities. Thus, multiorgan transplantation should be considered in such a patient population. Our patient received Aviptadil as part of an EIND to stabilize patients and improve oxygenation while waiting on the transplant list. Conclusion(s): We propose that SLK transplantation should be considered for carefully selected patients with COVID-19 ARDS.

14.
American Journal of Transplantation ; 22(Supplement 3):560-561, 2022.
Article in English | EMBASE | ID: covidwho-2063387

ABSTRACT

Purpose: The coronavirus disease 2019 (COVID-19) global pandemic has seen the development of effective vaccines in record time. We report a series of five liver transplant (LT) recipients who developed acute cellular rejection (ACR) after receiving COVID-19 vaccinations. Method(s): We performed a single-center, retrospective review of LT recipients who presented with biopsy-proven ACR after receiving a COVID-19 vaccination. Result(s): 603 LT recipients were fully vaccinated against COVID-19 at our center on 10/4/2021. Five (0.77%) patients developed elevated liver enzymes after COVID-19 vaccination without an identifiable cause and had a subsequent liver biopsy consistent with ACR: four (80%) patients were male and the median age was 54 years old. The indication for LT was cirrhosis secondary to non-alcoholic steatohepatitis in three (60%) and alcohol in two (40%) patients. The median time from LT to the first dose of COVID-19 vaccination was 19 months (range 7-26 months). Three (60%) patients had moderate (RAI= 5/9) ACR. All patients were treated with high-dose intravenous methylprednisolone for 3 days and had normalization of liver enzymes. No patients required rescue therapy with anti-thymocyte globulin or developed graft failure. All patients eventually completed their vaccination series. Conclusion(s): LT recipients may be at risk for developing ACR after the COVID-19 vaccination. Further study is required to better understand this relationship while closer monitoring following vaccination may be warranted in this patient population. (Figure Presented).

15.
Neuro-Oncology ; 24(Supplement 2):ii88-ii89, 2022.
Article in English | EMBASE | ID: covidwho-2062942

ABSTRACT

BACKGROUND: A novel therapeutic approach using molecularly targeted radiation is currently in development for patients with recurrent GBM. Many tumor types, including GBM, overexpress the L-type amino transporter 1 (LAT-1)4, which is able to internalize the small-molecule amino acid derivative, 4-L-[131I] iodo-phenylalanine (131I-IPA). In preclinical research, combining 131I-IPA with external radiation therapy (XRT) yielded addi- tive cytotoxic effects. Tumoral accumulation of 131I-IPA was confirmed in a proof-of-principle study using single doses of 2-7 GBq 131I-IPA as a monotherapy or in combination with XRT in patients with recurrent GBM. The objective of the IPAX-1 study was to evaluate the safety, tolerability, dosing schedule, and preliminary efficacy of 131I-IPA in combination with secondline radiotherapy in patients with recurrent GBM. METHOD(S): IPAX-1 is a multi-center, open-label, single-arm, dose-finding phase 1/2 study. Key inclusion criteria: 1. Confirmed histological diagnosis of GBM with evidence of first recurrence 2. History of GBM standard therapy 3. >= 6 months since end of first-line XRT 4. Pathologically increased amino acid tumor uptake shown by molecular imaging 5. Current indication for repeat radiation 6. Gross tumour volume of up to 4.8 cm diameter. Treatment: In phase 1 of the study patients received intravenous 131I-IPA at a dose level of 2 GBq administered in one of three different dosing regimens: single dose group with 2 GBq before radiation, 3 (f)-fractionated-parallel group: 3 x 0.67 GBq during XRT and 3 (f)-fractionated-sequential group: 0.67 GBq x 1 -> XRT -> 0.67 GBq x 2. XRT is delivered in 18 fractions of 2 Gy each. RESULT(S): 10 patients were randomized;one patient with Covid related death was withdrawn from analysis. Survival from start of TLX101 therapy showed mPFS2 of 4.33 M (95% -CI 4.18 - 4.48), PFS-6: 18 % and mOS2 of 15.97 M (95% -CI 2.9 - 29.1) at data lock 09/2021. Updated results will be presented at the meeting. CONCLUSION(S): There were no clinically relevant laboratory changes over time. Urinalysis, vital signs, and ECG did not show any clinically relevant changes from baseline. There were no notable differences in safety and tolerability between groups. Injections of single or fractionated doses of 131I-IPA containing a total activity of 2 GBq in combination with XRT in patients with recurrent GBM were safe and well tolerated. Survival data look promising;extension cohort will be treated in a phase II study in Linz;phase 1/2 study in first line setting is planned.

16.
Clinical Toxicology ; 60(Supplement 2):2, 2022.
Article in English | EMBASE | ID: covidwho-2062731

ABSTRACT

Background: Drug shortages represent a longstanding challenge for healthcare providers, including toxicologists, who continue to confront scarcities of antidotes and other agents used to treat poisonings. Prior research examining availability of drugs with toxicologic applications from 2001 to 2013 demonstrated broad shortages including anticholinergic, cholinergic, and cyanide antidotes, anti-hypoglycemics, chelators, antivenom, naloxone, sedative- hypnotics, and decontamination products, many of which were unresolved and involved xenobiotics without therapeutic alternative. Reports of vital agents being scarce or unobtainable have continued since 2013, and new pressures on global and US (United States) supply chains have emerged, most notably the COVID-19 pandemic. Given this, up-to-date analysis of shortages of agents used to treat poisonings is needed. Method(s): US drug shortage data from January 2012 to December 2021 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, shortage reason, shortage duration, number of manufacturing sources, substitute availability, and substitute agent shortage during the study period were investigated. Result(s): 1570 drug shortages were reported during the study period;230 (14.6%) involved agents used to treat poisonings. Of the 230 shortages, 21.3% were unresolved as of December 2021. Mean shortage duration was 13.6 months. The longest shortage involved intravenous calcium gluconate and lasted 78 months. Intravenous dextrose products were the agent most frequently affected by shortage, with 20 shortages in total. 58 agents had multiple shortages. Total shortages peaked in 2017 with 33 shortages reported. 20 shortages were reported in 2020 and 24 in 2021 during the COVID-19 pandemic. 10.9% of shortages involved single-source products;however, this number is limited by incomplete reporting. 80.9% of shortages involved parenteral products. Agent classes with the most shortages reported were: Sedative-hypnotics (12.2% of shortages), anti-hypoglycemics (9.6%), anticoagulant reversal (7.8%), vitamins/electrolytes (7.4%), blood pressure support (7%), antihypertensives (6.5%), antimuscarinic delirium (4.8%), and chelators (4.3%). Three naloxone shortages were reported, one of which is ongoing due to increased demand. Buprenorphine and methadone shortages were reported but are resolved as of December 2021. New shortages of multiple pressors and flumazenil were reported. The most common reason for shortage was a manufacturing issue, occurring in 36.1% of shortages. Shortage reason was not reported 37.8% of the time. For 77% of shortages an alternative therapeutic agent was available, however 97% of alternatives were also affected by shortage at some point during the study period. Conclusion(s): Shortages of agents used to treat poisonings remain problematic. For the time period 2011-2021 previously reported shortages of many products persist and new shortages have emerged. The ongoing naloxone shortage is particularly concerning given the continued rise in drug overdose deaths in the US in 2021, as are shortages of buprenorphine and methadone used to treat opioid use disorder. Despite supply chain stressors, total shortages did not peak during the COVID-19 pandemic.

17.
Clinical Toxicology ; 60(Supplement 2):121, 2022.
Article in English | EMBASE | ID: covidwho-2062721

ABSTRACT

Background: Palytoxin poisoning is an uncommon exposure in the US, and is most frequently encountered amongst hobbiests and professionals in the aquarium industry. The toxin is produced by the microalgae Ostreopsis as well as the coral Palythoa toxica. Discovered in Hawaii, the name limu-make-o-Hana translates to "seaweed of death from Hana." Palytoxin interrupts Na+/ K+ ATPase pump, resulting in widespread cellular dysfunction. Persons are at highest risk when cleaning a fish tank housing the coral that produces palytoxin, resulting in cutaneous or inhalational exposure. We present a case of palytoxin inhalational exposure with computed tomography (CT) imaging. Case report: A 41-year-old male presented to the emergency department (ED) with dyspnea, cough, and wheezing after cleaning his saltwater fish tank. He reported that he maintains Zoanthid corals in his home saltwater fish tank and typically wears personal protective equipment when cleaning the tank. He had taken off his mask directly after using hot water to clean the tank, and quickly developed shortness of breath. He contacted Poison Control and was instructed to take loratadine with initial improvement in his symptoms. He then developed decreased appetite, nausea, and chills. The following day, in addition to these symptoms, he developed a fever of 102.5 degreeF and an oxygen saturation of 88% measured with an at-home pulse oximeter. He then proceeded to the ED where he was found to be hypoxic to 91% on room air, tachycardic to 120 bpm, hypotensive to 93/ 70mmHg, febrile to 100.9 degreeF and tachypneic at a respiratory rate of 30. Physical exam revealed clear lung sounds. Application of supplemental oxygen at 2 L resulted in improvement in his oxygen saturation and his hypotension and tachycardia responded to intravenous fluids. Significant laboratory results included WBC count of 20.4 with bands of 14%, elevated lactate of 2.4mmol/L, elevated D-dimer of 0.48 mug/mL and a negative COVID PCR test. CTA thorax revealed patchy ground-glass opacities in the bilateral upper and lower lobes with mosaicism. The patient received doxycycline in addition to broad spectrum antibiotics due to concern for inhalational marine toxicity. He was also started on 60mg prednisone, inhaled steroids, and bronchodilators for symptomatic treatment, with improvement in his symptoms. During his hospitalization, a respiratory viral panel was negative for common viruses associated with atypical pneumonia including influenza, coronavirus, metapneumovirus, rhinovirus, enterovirus, adenovirus, parainfluenza, bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumonia. His dyspnea gradually improved and he was weaned off supplemental oxygen prior to discharge home on hospital day 2. Discussion(s): It is unclear what changes are expected on thoracic imaging in patients with inhalational palytoxin exposure. Chest radiographs in two previous cases displayed scattered infiltrates, and a chest CT in another case showed pleural based consolidations. The ground-glass mosaicism suggests that a more diffuse reactive airway process after an inhalational palytoxin insult. Conclusion(s): Patients with inhalational palytoxin exposure may be found to have reactive airway symptoms along with ground glass opacities with mosaicism on CT imaging.

18.
Osteologie ; 30(3):203, 2022.
Article in English | EMBASE | ID: covidwho-2062343

ABSTRACT

Care of osteoporosis patients during COVID-19 pandemic is challenging. Due to lockdowns and restrictions, the management of osteoporosis has changed. Diagnosis of osteoporosis decreased and the influence of COVID-19 on drug prescriptions and dispensing is currently unclear. Therefore, the aim of the study was to assess the dispensing of anti-osteoporotic drugs during the Covid19 pandemic. Methods This study was a nationwide retrospective register-based observational study which included all patients in Austria aged >= 50 who received at least one prescription for anti-osteoporotic drug between January 2016 and November 2020. Pseudonymized individual-level patients' data were obtained from social insurance authorities and the Federal Ministry of Labour, Social Affairs, Health and Consumer Protection in Austria. Anti-osteoporotic agents were divided into: (i) oral bisphosphonates, (ii) intravenous bisphosphonates, (iii) selective estrogen receptor modulators (SERMs), (iv) teriparatide (TPTD) and (v) Denosumab (DMAB). We used interrupted time series analysis with autoregressive integrated moving average models (ARIMA) for the prediction of drug dispensing. Results There were 2,884,627 dispensing of anti-osteoporotic drugs by 318,573 patients between 2016-2020. The mean monthly prescriptions for oral bisphosphonates (-14.5 %) and SERMs (-12.9 %) decreased during COVID-19 pandemic, compared to the non-COVID-19 period. The dispensing for intravenous bisphosphonates (1.7 %) and teriparatide (9.5 %) increased during COVID- 19. The prescriptions for DMAB decreased during the first lock-down in March and April 2020 (24 %), however increased by 29.1 % for the total observation time. The ARIMA model for alendronate showed, that the estimated step change was minus 1443 dispensing (95 % CI - 2870 to - 17), while the estimated change in slope was minus 29 dispensing per month (95 % CI - 327 to 270). Thus, there were 1472 (1443 + 29) fewer dispensing in March 2020 than predicted had the lockdown not occurred. Discussion The total number of prescriptions dispensed to patients treated with anti-osteoporotic medications declined rapidly during the first COVID-19 lockdown. The largest drops in absolute terms were observed for ibandronate, followed by alendronate, denosumab, zolendronic acid and risendronate. The observed decrease of DMAB during the first lockdown, was compensated in the following months. Current evidence suggests no need for discontinuation of anti-osteoporotic drugs during COVID-19 pandemic, nor because of vaccination. Taking into account the massive treatment gap for osteoporosis, and the related fracture risk, clinicians should continue treatment, even in times of pandemics.

19.
Cardiology in the Young ; 32(Supplement 2):S171-S172, 2022.
Article in English | EMBASE | ID: covidwho-2062129

ABSTRACT

Background and Aim: Cardiac involvement is seen in the majority of cases with multisystem inflammatory syndrome in children (MIS-C). Various rhythm and conduction disturbances, as well as repolarization abnormalities, have been described by more than 50% of the patients, while there are few cases with complete heart block or with asystole. Method(s): Case report Results: 8-year old girl presented with a 5-day history of fever, cough, headache, and abdominal pain. Because of the critical con-dition, with respiratory insufficiency and heart failure symptoms, the child was intubated and started on inotropic support. ECG showed complete AV-block with a ventricular rate of 75/min and with ST-T changes;echocardiography revealed dilated left ventricle with reduced contractility, CT-scan of the lungs showed bilateral pneumonia, the inflammatory markers were elevated, in combination with high troponin levels, and positive SARS-CoV2-IgG antibodies. The diagnosis MIS-C was made and treatment with immunoglobulins, antibiotics, corticosteroids, and anticoagulants was initiated. During the next 2 days, the cardiac function deteriorated further, and while still on mechanical ventilation and inotropic support, extreme bradycardia with a ventricular rate of 35/min was regis-tered, and the patient was indicated for temporary emergency pac-ing. Upon induction of anesthesia, the child became asystolic, requiring extensive resuscitation. After circulation recovery, the ECG showed nodal tachycardia with a heart rate of 140-170/min. A temporary transvenous pacemaker (PM) was inserted, and the patient was started on intravenous amiodarone which resulted in a slower ventricular rate of 70/min. 3 days later sinus rhythm was restored, with first-degree AV-block, which allowed removal of the PM 5 days after its insertion. Left ventricular dimensions were normalized and contractility remained low-normal (EF 56%). During the 6-month follow-up, the ECG and the Holter-monitoring showed sinus rhythm with first-degree AV-block. Magnetic resonance imaging (MRI) on day 15 of the hospital stay demonstrated scattered areas of myocarditis and ischemia predominantly in the left ventricle, as well as thickening of the basal septum. Six months later the MRI changes were reduced but still persistent. Conclusion(s): MIS-C can present with serious and life-threatening rhythm and conduction disturbances in children;this is why extensive cardiac monitoring is obligatory by all patients.

20.
Cardiology in the Young ; 32(Supplement 2):S183, 2022.
Article in English | EMBASE | ID: covidwho-2062120

ABSTRACT

Background and Aim: Multisystem inflammatory syndrome in chil-dren (MIS-C) is a late manifestation of SARS-CoV-2 infection. Cardiac involvement is common and presents as ventricular dys-function, shock, and coronary anomalies. The aim of the study is evaluate the influence of cardiac disfunction on clinical presen-tations and outcomes in a single center. Method(s): A retrospective study on patients diagnosed with MIS-C and referred to Buzzi Children's Hospital in Milan from November 2020 to February 2021. Patients were treated with intravenous immunoglobulins, corticosteroids and anti-throm-botic prophylaxis, in respect to our approved multidisciplinary protocol. According to the admission cardiac left ventricular ejec-tion fraction (LVEF), the patients were divided into group A (LVEF lt;45%) and group B (LVEF >=45%). Result(s): We collected 32 consecutive patients. Group A included 10 patients (9M/1F, aged 13 years [IQR 5-15]), and group B included 22 patients (15M/7M, aged 9 years [IQR 7-13]). At the presentation, significant differences were observed among shock (group A 6/10 vs group B 2/22, plt;0.01), gastrointestinal involvement (9/10 vs 11/22, p = 0.04) and duration of fever (5.3 vs 6.9 days, p = 0.02). All patients in group A required inten-sive care hospitalization (10/10 vs 12/22, p = 0.01). Interestingly, despite good cardiac function, two patients in group B presented with shock, probably due to vasoplegic/distributive cardiocircula-tory impairment secondary to the inflammatory state. Among biochemistry parameters, leukocytes, neutrophils, and CRP were significantly worse in group A (p = 0.001, p = 0.001 and p = 0.008, respectively). Pathological level of troponin T and NTproBNP were detected in all patients in group A and also in 33% and 77% of group B;with statistically significant higher median values in group A (Troponin T 72 [40-243] ng/L vs 22 [8-49] ng/L, p = 0.01;NTproBNP 14825 [11340-17810] ng/L vs 5921 [1114-11243] ng/L, p = 0.01). In group A, mitral regurgitation was more frequent (plt;0.01) and one patient had transient left main coronary dilation (Boston z-score +2.39). At the discharge, cardiac function normalized in all patients. Total length of hospital stay and cardiac recovery time were not statistically different between groups. Conclusion(s): If correctly diagnosed and early treated, all the MIS-C patients completely recovered, regardless of the initial cardiac involvement.

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