scholarly journals POS1233 USE OF BARICITINIB AND TOCILIZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE COVID-19 IN HOSPITALIZED PATIENTS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 899.3-900
Author(s):  
D. X. Xibille Friedmann ◽  
S. M. Carrillo Vazquez

Background:SARS-CoV2 infection and COVID-19 associated pneumonia are associated to a dysregulated inflammatory response known as cytokine storm and the use of cytokine inhibitors, especially those targeting IL-6, has been proposed as a therapeutic alternative in these patients. Janus Kinase (JAK) inhibitors in combination to the antiviral Remdesivir have shown evidence of reducing recovery time and accelerating improvement in clinical status among patients with COVID-19, notably among those receiving high-flow oxygen or noninvasive ventilation1.Objectives:To describe the outcomes associated with the use of Tocilizumab (TCZ) and Baricitinib (Bari) in patients hospitalized for COVID-19.Methods:Descriptive study nested in a cohort. Patients from the General Hospital of Cuernavaca who were hospitalized due to COVID-19 associated pneumonia and/or respiratory failure requiring supplemental oxygen or invasive/non-invasive assisted mechanical ventilation (AMV) were analyzed. All patients had a positive RT-PCR upon hospital admission, sampled under standardized conditions. The clinical and demographic data of the patients upon hospitalization were obtained from the instrument on a specific platform (SISVER) used on a national basis. Severe disease was considered as the need for any type of AMV. TCZ was used at 400-600 mg in two infusions (baseline and at 72 hours), Bari at 4 mg daily for 14 days. The outcomes were the need for AMV, death, or discharge. A p≤ 0.05 was considered statistically significant.Results:Data from 404 SARS-CoV2 positive patients were analyzed. 269 (65.9%) were men. The mean age of the patients was 57.5 years (18-94; SD 15.3). 59.6% of the patients had one or more comorbidities (Diabetes and Hypertension in most cases [31.8%]). 22.8% of the patients had a history of current or previous smoking. Mean hospital stay was 7.4 days (1-36; SD 5.9). 15.9% of the patients required invasive or non-invasive AMV. 11 patients were treated with TCZ and 30 patients received treatment with Baricitinib. 5 of the 11 patients with TCZ required AMV (all but one were intubated), but only 6 of the 30 (20%) with Bari required AMV (all except one received CPAP). The use of Baricitinib was correlated with a reduction in the use of AMV (p 0.01). 6 patients with TCZ were discharged due to improvement and 5 died. In the case of Bari, 19 improved and were discharged and 11 died, significantly correlating with lower mortality (p 0.05). The use TCZ was not associated with a reduced hospitalization (50% remained hospitalized for more than 10 days) but patients receiving Baricitinib had significantly shorter hospital stays (86.6% had a hospital stay of less than 10 days) than those receiving TCZ (p<0.0001).Conclusion:The patients that were treated with Baricitinib and required AMV most often improved with non-invasive CPAP while the majority of the patients under AMV receiving TCZ were treated with an invasive mode, although this was due in part to the fact that TCZ can be employed intravenously and is more practical for intubated patients in whom oral drug administration is limited. Baricitinib was significantly associated with a better outcome (hospital discharge due to improvement) and a significantly shorter hospital stay.References:[1]Kalil, A.C.; Patterson, T.F.; Mehta, A.K.; Tomashek, K.M.; Wolfe, C.R.; Ghazaryan, V.; Marconi, V.C.; Ruiz-Palacios, G.M.; Hsieh, L.; Kline, S.; et al. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N. Engl. J. Med. 2020.Acknowledgements:Thanks to B. Flores and M. Hernandez for their help with data collection.Disclosure of Interests:Daniel Xavier Xibille Friedmann Speakers bureau: Lilly, Abbvie, Paid instructor for: Lilly, Abbvie, Consultant of: Pfizer, Lilly, Sandra Miriam Carrillo Vazquez Speakers bureau: Roche, Novartis, Paid instructor for: Roche, Janssen, Consultant of: Roche, Janssen

2021 ◽  
pp. 1-3
Author(s):  
Miguel Oliveira Santos ◽  
Sara Domingues ◽  
Marta Gromicho ◽  
Susana Pinto ◽  
Mamede de Carvalho

Background: The impact of SARS-CoV-2 infection among neuromuscular diseases with respiratory involvement, including amyotrophic lateral sclerosis (ALS), is still to be elucidated. Objectives: We aim to characterize the clinical outcome of ALS patients non-invasive ventilated (NIV), following SARS-CoV-2 infection. Methods: We analyzed retrospectively our patients followed regularly at our ALS clinic, from the beginning of the COVID-19 pandemic (middle March 2020) to March 2021. We included patients on NIV with a documented SARS-CoV-2 infection. We recorded demographic and clinical data, including from the acute infectious illness. Results: Three men with spinal-onset ALS are described, mean age of onset was 55±9.1 years (45–61), and mean disease duration was 17.5±15.9 months (6.1–41). All of them were wheelchair-bounded, with a mean ALSFRS-R of 15.3±0.6 (15–16). One patient used NIV 15 hours/day, 2 between 4 to 7 hours/day, and all used assisted coughing twice daily. None had coexistent comorbidities. They were managed for SARS-CoV-2 infection as outpatients with fluticasone, bronchodilators, azithromycin and increasing frequency of assisted coughing. Supplemental oxygen (mean of 2 liters per minute) was needed in two patients, and one required NIV also during the daytime. Total recovery from SARS-CoV-2 infection was observed in all, despite being in an advanced stage of their disease, with severe respiratory involvement. Conclusions: Prompt medical treatment is recommended for ALS patients with severe disease infected by SARS-CoV-2.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S261-S262
Author(s):  
Nina Vrsaljko ◽  
Lara Samadan ◽  
Jelena Budimir ◽  
Mirjana Balen Topic ◽  
Ivan Kurelac ◽  
...  

Abstract Background Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease with a prevalence up to 30%. NAFLD is strongly associated with components of metabolic syndrome, already recognized as risk factors for worse outcomes in COVID-19. However, the impact of NAFLD on COVID-19 is not well characterized. The aim of this study was to investigate a possible association between NAFLD and COVID-19 severity and outcomes. Methods A prospective observational study included consecutively hospitalized adult patients with severe COVID-19 at the University Hospital for Infectious Diseases in Zagreb, Croatia between March and June 2021. On admission patients were screened for fatty liver by the ultrasound and subsequently diagnosed with NAFLD according to current guidelines. Demographic, clinical and laboratory data was collected and correlated to clinical outcomes. Results Of the 112 patients included in the study, 77 (68.7%) had NAFLD (59.7% males; median age of 62, IQR 54-66 years). Except for higher prevalence of obesity in NAFLD group (61.0% vs 17.1%) there were no differences in other comorbidities. NAFLD group had higher inflammatory markers CRP (96, IQR 51-138 vs 59, IQR 29-99mg/L) and IL-6 (129, IQR 44-169 vs 25, IQR 8-56pg/mL). Steatosis stage showed positive correlation with BMI, waist/hip ratio, CRP, PCT, IL-6, AST, ALT, LDH and fibrinogen. Steatosis stage correlated with clinical status at the 7-category scale on admission and at days 7, 14 and 28. Patients with NAFLD had longer duration of hospitalization (9, IQR 6-15 vs 6, IQR 5-11 days, p=0.024), more frequently required noninvasive ventilation or high-flow oxygen (24.7% vs 5.7%, p=0.018) and had higher rate of pulmonary embolism (22.1% vs 5.7%, p=0.024). There was no difference in mortality. The median value for clinical status on the ordinal scale at day 7 was significantly higher in NAFLD group at days 7 and 14, as presented in Fig. 1. Multivariable analysis identified age &gt; 65 (OR 3.6, 95%CI 1.3-10.9), LDH &gt; 350 (OR 8.1, 95%CI 2.7-29.4), NAFLD (OR 3.9, 1.1-20.5) and pulmonary embolism (OR 10.4, 2.7-48.3) associated with adverse outcomes at day 28. The figure shows the patients’ clinical status as assessed on the seven-category ordinal scale on admission and at day 7, 14 and 28, according to the presence of NAFLD. Categories on the ordinal scale were as follows: 1, discharged or ready for discharge; 2, hospitalization in a non–intensive care unit (ICU) without supplemental oxygen; 3, non–ICU hospitalization with supplemental oxygen; 4, ICU or non–ICU hospitalization with noninvasive ventilation or high-flow oxygen; 5, ICU hospitalization with mechanical ventilation; 6, ICU hospitalization with extracorporeal membrane oxygenation or mechanical ventilation and additional organ support; and 7, death. Conclusion Our data suggests that NAFLD is associated with COVID-19 severity and might be linked to adverse outcomes in hospitalized patients. Disclosures All Authors: No reported disclosures


2020 ◽  
Author(s):  
Wei Enli Wycliffe ◽  
Tan Cher Heng ◽  
Monica Chan ◽  
Tan Thuan TOng ◽  
Surinder Kaur Pada ◽  
...  

Abstract BackgroundTo evaluate the utility of age and chest radiography(CXR) in triaging COVID-19 patients for hospitalization versus isolation in non-hospital facilities, we examined how age and CXR at diagnosis were associated with clinical needs from late-January to early-April. MethodsClinical status of all COVID-19 cases was monitored for national disease surveillance. Cases were isolated in hospitals until SARS-CoV-2 RNA was undetectable on PCR. Age and CXR results on admission were analysed for association with oxygen supplementation and mechanical ventilation, the outcomes of interest.ResultsTill 4 April 2020, there were 1,481 COVID-19 cases in Singapore. Overall, 11.4% required supplemental oxygen while 4.8% required mechanical ventilation and intensive care. The respective proportions increased to 40.9% and 16.5% for cases aged ≥70 years. As a predictor of subsequent mechanical ventilation, age had an area under the receiver operator characteristic curve(AUROC) of 0.772 (95%CI:0.699-0.845). A combined criterion of either an abnormal CXR or age≥55 years had a sensitivity of 86.7% and specificity of 58.0% for the same outcome. A similar performance was observed for predicting oxygen supplementation needs.ConclusionsAge and CXR at diagnosis may be valuable in excluding severe disease, allowing safe triage for isolation in non-hospital facilities.


2021 ◽  
Author(s):  
Anil Gupta ◽  
Yaneicy Gonzalez-Rojas ◽  
Erick Juarez ◽  
Manuel Crespo ◽  
Jaynier Moya ◽  
...  

Importance: Older patients and those with underlying comorbidities infected with SARS-CoV-2 may be at increased risk of hospitalization and death from COVID-19. Sotrovimab is a neutralizing antibody designed for treatment of high-risk patients to prevent COVID-19 progression. Objective: To evaluate the efficacy and safety of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease. Design: Randomized, double-blind, multicenter, placebo-controlled, phase 3 study. Setting: 57 centers in 5 countries. Participants: Nonhospitalized patients with symptomatic, mild to moderate COVID-19 and at least 1 risk factor for disease progression. Intervention: Patients were randomized (1:1) to an intravenous infusion of sotrovimab 500 mg or placebo. Main Outcomes and Measures: The primary efficacy outcome was the proportion of patients with COVID-19 progression, defined as all-cause hospitalization longer than 24 hours for acute illness management or death through day 29. Key secondary outcomes included the proportion of patients with COVID-19 progression, defined as emergency room visit, hospitalization of any duration, or death, and proportion of patients developing severe/critical respiratory COVID-19 requiring supplemental oxygen. Results: Among 1057 patients randomized (sotrovimab, 528; placebo, 529), all-cause hospitalization longer than 24 hours or death was significantly reduced with sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) by 79% (95% CI, 50% to 91%; P<.001). Secondary outcome results further demonstrated the effect of sotrovimab in reducing emergency room visits, hospitalization of any duration, or death, which was reduced by 66% (95% CI, 37% to 81%; P<.001), and severe/critical respiratory COVID-19, which was reduced by 74% (95% CI, 41% to 88%; P=.002). No patients receiving sotrovimab required high-flow oxygen, oxygen via nonrebreather mask, or mechanical ventilation compared with 14 patients receiving placebo. The proportion of patients reporting adverse events was similar between treatment groups; sotrovimab was well tolerated, and no safety concerns were identified. Conclusions and Relevance: Among nonhospitalized patients with mild to moderate COVID-19, a single 500-mg intravenous dose of sotrovimab prevented progression of COVID-19, with a reduction in hospitalization and need for supplemental oxygen. Sotrovimab is a well-tolerated, effective treatment option for patients at high risk for severe morbidity and mortality from COVID-19.


Author(s):  
Dr.Randa Mohammed AboBaker

Postoperative Ileus (POI) is one of the most common problems after obstetrics, gynecologic and abdominal surgeries. Sham feeding, such as gum chewing, accelerates the return of bowel function and the length of hospital stay. The present study aims to evaluate the effect of chewing gum on bowel motility in women undergoing post-operative cesarean section. Intervention study was used at the Postpartum Department of Maternity and Children Hospital, KSA. A randomized controlled clinical trial research design. Through a convenience technique, 80 post Caesarian Section (CS) women were included in the study. Data were collected through three tools: Tool (I): Socio-demographic data and reproductive history interview schedule. Tool (II): Postoperative Assessment Sheet. Tool (III): Outcomes of gum chewing and the length of hospital stay.  Method: subjects were assigned randomly into two groups of (40) the experimental and (40) the control. Subjects in the study group were asked to chew two pieces of sugarless gum for 30 min/three times daily in the morning, noon, and evening immediately after recovery from anesthesia and in Postpartum Department; while subjects in the control group followed the hospital routine care. Each woman in both groups was tested abdominally using a stethoscope to auscultate the bowel sounds and asked to report immediately the time of either passing flatus or stool. Results: illustrated that a highly statistically significant difference was observed between the two groups concerning their gum chewing outcomes. Where, P = 0.000. The study concluded that gum chewing is safe, well tolerated and appears to be effective in reducing the incidence and consequences of POI following CS.


Author(s):  
Gökhan Akkurt ◽  
Burcu Akkurt ◽  
Emel Alptekın ◽  
Birkan Birben ◽  
Mehmet Keşkek ◽  
...  

Aim: The aim of this study is to investigate the efficacy of thiol disulfide homeostasis and Ischemia Modified Albumin (IMA) values in predicting the technical difficulties that might be encountered during laparoscopic cholecystectomy. Materials and Methods: The study included 65 patients who underwent laparoscopic cholecystectomy due to cholelithiasis at the General Surgery Clinic of Ankara Numune Training and Research Hospital. All patients’ demographic data, previous history of cholecystitis, a history of chronic illness, preoperative white blood count (WBC), liver function tests (AST, ALT), amylase and lipase levels, intra-operative adhesion score, the ultrasonographic appearance of gallbladder, duration on hospital stay, duration of operation, thiol disulfide and IMA values were evaluated. Results: Native thiol and total thiol averages were higher in patients without a history of cholecystitis, on the other hand, disulfide, disulfide/native thiol rate, disulfide/total thiol rate, native thiol/total thiol rate and IMA averages were higher in patients with a history of cholecystitis. While there was a statistically significant negative correlation between native and total thiol values and age, duration of surgery and duration of hospital stay; IMA, disulfide, disulfide/Total thiol, Native/Total thiol and disulfide/Native thiol rates were higher in older patients with a longer duration of surgery and hospital stay. In addition, preoperative IMA, disulfide, disulfide/Total thiol, Native/Total thiol and disulfide/Native thiol were observed to increase as the degree of intraoperative pericholecystic adhesion increased. Conclusion: We believe that the evaluation of thiol disulfide homeostasis and IMA parameters prior to laparoscopic cholecystectomy can be used as an effective method for predicting intraoperative difficulties.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A269-A269
Author(s):  
Vaishal Shah ◽  
Nancy Foldvary-Schaefer ◽  
Lu Wang ◽  
Lara Jehi ◽  
Cynthia Pena Obrea ◽  
...  

Abstract Introduction The relationship of OSA and human coronavirus (COVID-19) in the pediatric population is unknown. We postulate that OSA is associated with SARS-CoV-2 positivity and with adverse COVID-19 outcomes in children. Methods A retrospective review of 120 consecutive patients (&lt;18 years) with prior polysomnogram (PSG) and COVID-19 testing from the Cleveland Clinic COVID-19 registry was conducted. Using a case control design of SARS-CoV-2 positive and negative pediatric patients, we examined COVID-19 and pre-existing OSA (dichotomized AHI≥1) using logistic (OR,95%CI) regression and as continuous measures: AHI, oxygen(SpO2) nadir, %time SpO2&lt;90%) using linear regression(beta+/-SE). In those positive for SARS-CoV-2(cases only), we assessed the association of OSA and World Health Organization(WHO) COVID-19 clinical outcome composite score (hospitalization, requiring supplemental oxygen, non-invasive ventilation/high-flow oxygen, invasive ventilation/ECMO or death) using Wilcoxon rank sum test for ordinal data. Results Cases (n=36) were 11.8±4.4 years, 61% male, 27.8% black and 88.9% with OSA, while 85.7% of controls (n=84) had OSA. OSA was not associated with increased SARS-CoV-2 positivity: OR=1.33(0.40, 4.45,p=0.64). No significant difference between cases and controls for mean AHI 3.7(1.5,6.0) vs 3.5(1.5,7.1),p=0.91,SpO2 nadir 88.6±5.4 vs 89.1±4.4,p=0.58,%time SpO2&lt;90% 0.05[0.00,1.00) vs 0.10 (0.00,1.00, p=0.65) respectively was noted. WHO-7 COVID-19 clinical outcome did not meet statistical significance in relation to OSA due to the low event frequency (p=0.49). Of note, those with OSA vs without OSA had a higher WHO-7 outcome score of 2 vs 0 and prevalence of hospitalization: 12.5 vs 0% respectively. Of hospitalized patients, the following was observed: 23% had moderate/severe OSA vs 4.3% mild OSA, 50% required supplemental oxygen and 25% required intubation/invasive ventilation. No deaths or readmissions were reported. High risk conditions included: 75% obesity, 50% asthma, 25% sickle cell disease and 25% hypoplastic left heart. Conclusion In this first report of which we are aware focused on COVID-19 in pediatric OSA, we use a case control design leveraging COVID-19 and sleep laboratory registries. Albeit not statistically significant, pediatric patients with OSA had a higher percentage of worse clinical outcomes. Larger network studies are needed to clarify whether poorer COVID-19 outcomes may be attributable to OSA or modulated via high risk health conditions. Support (if any):


Sign in / Sign up

Export Citation Format

Share Document