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1.
JAMA ; 329(1):39, 2023.
Article in English | ProQuest Central | ID: covidwho-2172180

ABSTRACT

Importance The longer-term effects of therapies for the treatment of critically ill patients with COVID-19 are unknown. Objective To determine the effect of multiple interventions for critically ill adults with COVID-19 on longer-term outcomes. Design, Setting, and Participants Prespecified secondary analysis of an ongoing adaptive platform trial (REMAP-CAP) testing interventions within multiple therapeutic domains in which 4869 critically ill adult patients with COVID-19 were enrolled between March 9, 2020, and June 22, 2021, from 197 sites in 14 countries. The final 180-day follow-up was completed on March 2, 2022. Interventions Patients were randomized to receive 1 or more interventions within 6 treatment domains: immune modulators (n = 2274), convalescent plasma (n = 2011), antiplatelet therapy (n = 1557), anticoagulation (n = 1033), antivirals (n = 726), and corticosteroids (n = 401). Main Outcomes and Measures The main outcome was survival through day 180, analyzed using a bayesian piecewise exponential model. A hazard ratio (HR) less than 1 represented improved survival (superiority), while an HR greater than 1 represented worsened survival (harm);futility was represented by a relative improvement less than 20% in outcome, shown by an HR greater than 0.83. Results Among 4869 randomized patients (mean age, 59.3 years;1537 [32.1%] women), 4107 (84.3%) had known vital status and 2590 (63.1%) were alive at day 180. IL-6 receptor antagonists had a greater than 99.9% probability of improving 6-month survival (adjusted HR, 0.74 [95% credible interval {CrI}, 0.61-0.90]) and antiplatelet agents had a 95% probability of improving 6-month survival (adjusted HR, 0.85 [95% CrI, 0.71-1.03]) compared with the control, while the probability of trial-defined statistical futility (HR >0.83) was high for therapeutic anticoagulation (99.9%;HR, 1.13 [95% CrI, 0.93-1.42]), convalescent plasma (99.2%;HR, 0.99 [95% CrI, 0.86-1.14]), and lopinavir-ritonavir (96.6%;HR, 1.06 [95% CrI, 0.82-1.38]) and the probabilities of harm from hydroxychloroquine (96.9%;HR, 1.51 [95% CrI, 0.98-2.29]) and the combination of lopinavir-ritonavir and hydroxychloroquine (96.8%;HR, 1.61 [95% CrI, 0.97-2.67]) were high. The corticosteroid domain was stopped early prior to reaching a predefined statistical trigger;there was a 57.1% to 61.6% probability of improving 6-month survival across varying hydrocortisone dosing strategies. Conclusions and Relevance Among critically ill patients with COVID-19 randomized to receive 1 or more therapeutic interventions, treatment with an IL-6 receptor antagonist had a greater than 99.9% probability of improved 180-day mortality compared with patients randomized to the control, and treatment with an antiplatelet had a 95.0% probability of improved 180-day mortality compared with patients randomized to the control. Overall, when considered with previously reported short-term results, the findings indicate that initial in-hospital treatment effects were consistent for most therapies through 6 months.

2.
Indian Journal of Forensic Medicine and Toxicology ; 17(1):97-101, 2023.
Article in English | EMBASE | ID: covidwho-2206443

ABSTRACT

Introduction: Coronavirus Disease-19 (COVID-19) caused by the severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) was declared a worldwide pandemic on March 11, 2020 and globally, on April 29, 2022, there were 510,270,667 confirmed COVID-19 cases, including 6,233,526 deaths, reported to WHO. As of April 2022, the Government of the Republic of Indonesia has reported 4,249,323 confirmed cases of COVID-19. There have been 143,592 COVID-19-related deaths reported and 4,096,194 patients have recovered from the disease. COVID-19 is associated with a high risk of venous thromboembolism (VTE), however, to date, optimal prophylactic anticoagulant therapy remains uncertain and may depend on the severity of COVID-19. Objective(s): The aim of this study was to determine the difference in efficacy and safety in administering prophylactic doses with intermediate/therapeutic doses in confirmed COVID-19 patients. Result(s): This study used 6 studies that met the inclusion of differences in efficacy and safety in administering prophylactic doses with intermediate/therapeutic doses in confirmed COVID-19 patients. Conclusion(s): From 6 studies, there were 2 studies comparing anticoagulant prophylactic doses with intermediate doses and 4 studies comparing anticoagualnt prophylactic doses with therapeutic doses. In all studies, there were no significant differences in thromboembolic events or all-cause mortality in COVID-19 patients. The incidence of bleeding at the intermediate and therapeutic doses increased compared to the prophylactic dose, but the difference was not significant. Copyright © 2023, Institute of Medico-legal Publication. All rights reserved.

3.
Lege Artis Medicinae ; 32(8-9):329-337, 2022.
Article in Hungarian | Scopus | ID: covidwho-2206082

ABSTRACT

Atrial fibrillation is one of the most important, common and clinically significant arrhythmia. This arrhythmia alone is the most common that causes stroke, other systemic thromboembolism (STE), and heart failure. Atrial fibrillation increases the risk of stroke 2.5-fold, the risk of heart failure 5-fold, and cardiovascular mortality 2- fold. Prevalence in patients over 20 years of age is already 3%, and higher in selected patient populations such as patients with hypertension, obesity, diabetes, heart failure, renal failure, and valvular disease. Atrial fibrillation may occur in 2.3% of people over 65 years of age. In the first half of 2010, the total number of patients with atrial fibrillation was estimated at 33.5 million (of which 20.9 million were men), but with regional heterogeneities. The incidence of atrial fibrillation is 0.2-0.4 / 1,000 per year. Prevalence - ba - sed on European data - in the under-50 age group is between 0.12-0.16%, in the 60-70 age group is between 3.7-4.2%, and in the 80 year and older population it can reach 10% to 17%. The number of newly diagnosed patients in Hungary is 0.46%, with a prevalence of 3.1%. In 2015, the number of patients treated with atrial fibrillation was 306,914 and the number of newly diagnosed patients was 45,333. Based on European surveys, 14-17 million patients are expected to have diagnosed atrial fibrillation by 2030, which means more than 100,000 new diagnosed cases per year than now. The incidence of atrial fibrillation is increasing, therefore its appropriate and up-todate treatment is particular importance both at the level of primary care and specia lized care. In this publication, the authors present guidelines and challenges related to anticoagulation in patients with atrial fibrillation. © 2022 Literatura Medica Publishing House. All rights reserved.

4.
Safety and Risk of Pharmacotherapy ; 10(3):293-301, 2022.
Article in Russian | EMBASE | ID: covidwho-2205740

ABSTRACT

Therapeutically, new oral anticoagulants (NOACs) are considered to be non-inferior or superior to vitamin K antagonists (warfarin). NOACs are included in current guidelines for the treatment of various cardiovascular diseases. Rivaroxaban medicinal products have been shown to effectively fight thrombotic complications of the new coronavirus infection, COVID-19. The wide clinical use of rivaroxaban products motivates the development of generics. The aim of the study was to compare the pharmacokinetics and safety of rivaroxaban medicinal products in a single-dose bioequivalence study in healthy volunteers under fasting conditions. Material(s) and Method(s): the bioequivalence study compared single-dose oral administration of Rivaroxaban, 10 mg film-coated tablets (NovaMedica Innotech LLC, Russia), and the reference product Xarelto, 10 mg film-coated tablets (Bayer AG, Germany), in healthy volunteers under fasting conditions. The open, randomised, crossover trial included 46 healthy volunteers. Each of the medicinal products (the test product and the reference product) was administered once;blood samples were collected during the 48 h after the administration. The washout between the study periods lasted 7 days. Rivaroxaban was quantified in plasma samples of the volunteers by high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Result(s): no adverse events or serious adverse events were reported for the test and reference products during the study. The following pharmacokinetic parameters were obtained for Rivaroxaban and Xarelto, respectively: Cmax of 134.6 +/- 58.0 ng/mL and 139.9 +/- 49.3 ng/mL, AUC0-48 of 949.7 +/- 354.5 ngxh/mL and 967.6 +/- 319.9 ngxh/mL, AUC0- of 986.9 +/- 379.7 ngxh/mL and 1003.6 +/- 320.4 ngxh/mL, T1/2 of 8.2 +/- 3.2 h and 7.8 +/- 3.3 h. The 90% confidence intervals for the ratios of Cmax, AUC0-48, and AUC0- geometric means were 88.04-108.67%, 89.42-104.92% and 89.44-104.81%, respectively. Conclusion(s): the test product Rivaroxaban and the reference product Xarelto were found to have similar rivaroxaban pharmacokinetics and safety profiles. The study demonstrated bioequivalence of the medicinal products. Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.

5.
Ukrainskyi Zhurnal Sertsevo-sudynnoi Khirurhii ; 30(4):115-121, 2022.
Article in Ukrainian | Scopus | ID: covidwho-2205700

ABSTRACT

An important point in the provision of highly specialized cardiac surgical care for combat trauma is deter-mination of the optimal time, method and volume of surgical intervention, taking into account the persisting threat of infection with the SARS-COV-2 virus and associated thrombotic complications. The aim. To investigate the mechanism of development and methods of prevention of thrombotic complications re-sulting from combat trauma against the background of the COVID-19 pandemic. Materials and methods. We analyzed clinical case of patient R., a 37-year-old soldier with a postinfarction throm-bosed aneurysm of the left ventricle. The patient underwent standard clinical and laboratory tests, electrocardiography, echocardiography, coronary angiography, computed tomography of the chest, duplex scanning of carotid arteries, arteries and veins of the upper and lower extremities. It was established that 4 months ago, during a combat mission, the service-man received a mine-explosive injury, shrapnel wounds of lower extremities, multifragmentary fracture of the right fibula and a gunshot wound to the right chest. The causes of post-traumatic myocardial infarction are mine-explosive injury, intramural course of the left anterior descending artery, young age, poorly developed collaterals of coronary arteries, long-term transportation during the stages of medical evacuation and post-traumatic stress disorder. A month ago, the patient was diagnosed with COVID-19, thromboembolism of the right main branch of the pulmonary artery, for which thrombolytic therapy was performed. Follow-up computed tomography showed the signs of thromboembolism of the pulmonary arteries. Ultrasound examination revealed thromboses of upper and lower limbs. Thrombotic complications against the background of combat polytrauma are the result of hypercoagulation, acute inflammation with the release of proinflammatory cytokines and damage of the endothelium. SARS-COV-2 infection triggers a state of hypercoagulation and creates additional conditions for the occurrence of arterial and venous thrombosis. Considering the nature of the thrombotic lesions, a decision was made to postpone the cardiosurgical intervention for 3 months. Conclusions. Thrombotic complications are an urgent problem after combat trauma. COVID-19 is an additional risk factor for hypercoagulation and a reason for delaying elective cardiac surgery. Conducting an electrocardiography to the wounded, regardless of age, is crucial for timely diagnosis and treatment of acute coronary events. It is important to initi-ate anticoagulant therapy after eliminating all possible sources of bleeding due to the high risk of thrombotic complications against the background of chest trauma and limb fractures. © 2022, Professional Edition Eastern Europe. All rights reserved.

6.
Indonesian Journal of Pharmacy ; 33(3):381-393, 2022.
Article in English | CAB Abstracts | ID: covidwho-2205056

ABSTRACT

Li Coagulopathy is a common predictor of mortality in COVID-19. Meanwhile, enoxaparin is an anticoagulant with anti-inflammatory, endothelial protection, and viral antagonist properties. Therefore, thromboprophylaxis with enoxaparin in COVID-19 is common in clinical settings. This study aims to assess enoxaparin's efficacy across different severity levels by examining its effect on primary outcomes comprising Length of stay (LOS), invasive mechanical ventilation, and mortality as well as secondary in the form of D-dimer, platelets, C-reactive protein (CRP), Neutrophil Lymphocyte Ratio (NLR), and Absolute Lymphocyte Count (ALC). During hospitalization, 269 patients received enoxaparin across varying severity levels comprising mild, moderate, and severe, while the Wilcoxon test was used to analyze the efficacy in each group. Additionally, the differences in patient characteristic profiles across the severity levels were determined using the Kruskal-Wallis test. The increase in mortality rate and the need for mechanical ventilation were directly proportional to the level of severity. D-dimer decreased from 1308.87 ng/ml to 979.83 ng/ml (p=<0,001) as well as from 1758.41 ng/ml to 1510.68 ng/ml (p=<0,001) in the mild and moderate levels respectively. The platelet increased from 225.65 to 369.39 x103/ micro l (p=<0,001) in mild and 256.77 to 398.97 x103/ micro l (p=<0,001) in moderate. Moreover, CRP improved in both mild 52.62 to 49.58 mg/l (p=0.031) and moderate 92.99 to 42.66 mg/l, (p=<0,001). Based on the results, enoxaparin effectively improves D-dimer, platelet, and CRP levels in mild and moderate but not in severe conditions, however, no effect was found on LOS, NLR, and ALC.

7.
Journal of the Japanese Association for Infectious Diseases ; 96(5):173-178, 2022.
Article in Japanese | GIM | ID: covidwho-2203545

ABSTRACT

Objective: This study was aimed at clarifying the clinical characteristics and prognosis of patients hospitalized with COVID-19 and the treatment strategies for COVID-19 in each surge of the COVID-19 pandemic. Subjects and methods: We retrospectively examined the data of 358 patients with confirmed COVID-19 (116 in surge 3, 137 in surge 4, and 105 in surge 5) who were admitted to the Yoshijima Hospital.

8.
Journal of Acute Disease ; 11(6):212-221, 2022.
Article in English | EMBASE | ID: covidwho-2201630

ABSTRACT

Thrombotic complications appear to be a major predictor of death in COVID-19 patients, and multiple studies have shown that anticoagulants can help to improve the outcome. The Food and Drug Administration's acceptance of non-vitamin K antagonist oral anticoagulants (NOACs) has sparked much excitement about their potential as a replacement for existing oral anticoagulants. NOACs target a single clotting factor, often activated factor X or thrombin, and involve the coagulation factor Xa inhibitors including apixaban, edoxaban, and rivaroxaban, and the thrombin inhibitor dabigatran. COVID-19 is an infectious disease that causes thrombotic events by inducing a pro-inflammatory and prothrombotic condition. This article provides a comprehensive overview of the mechanism behind enhanced thrombogenicity accompanying COVID-19, the clinical range of NOACs, and the role of NOACs in treatment of COVID-19 based on recent investigations and clinical trials. Copyright ©2022 Journal of Acute Disease Produced by Wolters Kluwer-Medknow.

9.
Medicina Balear ; 37(6):72-83, 2022.
Article in English | Web of Science | ID: covidwho-2198579

ABSTRACT

Objectives: At present, the novel coronavirus disease 2019 (COVID-19) pandemic is the most important infectious disease worldwide. Due to false positives and false negatives of PCR results in the diagnosis of coronavirus infection, Computed Tomography (CT) is especially important in the initial diagnosis and assessment of the intensity of COVID-19 infection. According to the stage and intensity of COVID-19 infection chest CT scan findings display different features. Although men, women, and different age groups may be equally affected, different epidemiological studies have shown differences in gender and age in intensity and mortality. Although there are many studies on radiological findings in COVID-19 infection, however limited literature reviews have been stated on the relationship between age and gender with radiological finding. Methods: This reviews summarized studies that evaluated the association age and gender with radiologic CT fndings. Results: In general, the findings of these studies show that different age and gender groups have different characteristics which can role in primary diagnosis, facilitate the classification of the initial prognosis in COVID-19 pneumonia. Conclusions: As an indicator for outcome, treatment, determining the intensity of the disease as well as the prognosis, nevertheless studies with higher sample sizes and multicenter are required.

10.
Journal of the American Board of Family Medicine: JABFM ; 35(6):1163-1167, 2022.
Article in English | MEDLINE | ID: covidwho-2198396

ABSTRACT

INTRODUCTION: Current research shows no increased risk of thromboembolic events with mild COVID-19 but does not account for comorbidities. The aim of this study was to examine the incidence of thromboembolic events, including pulmonary embolism, cerebral infarction, and deep vein thrombosis, in nonhospitalized patients diagnosed with COVID-19 while accounting for comorbidities such as diabetes, asthma, COPD and cancer. METHODS: We completed a large retrospective observational analysis of adult patients within a large urban health system. RESULTS: Using a logit framework (with and without propensity score weighting), there was no increased risk of thromboembolic events among patients positive for SARS-CoV-2 who did not require hospitalization for COVID-19. CONCLUSION: This data suggest prophylactic anticoagulation is likely not warranted in the outpatient setting.

11.
Revista Romana de Cardiologie ; 32(3):138-143, 2022.
Article in English | Scopus | ID: covidwho-2198337

ABSTRACT

Infection with SARS-CoV-2 virus (COVID-19 disease) is associated with increased levels of inflammation and hypercoagulability. The risk of thrombosis includes the venous thromboembolic events (VTE), both distal venous thrombosis (DVT) and acute pulmonary embolism (PE) during a hospital stay that is ongoing after discharge, although how long this persists is unknown. The most frequent initial and late thrombotic complication is PE, as part of VTE. The evidence we have suggests quite a similar incidence (≤2%) of post-discharge VTE to that seen in other acutely ill patients. The current guidelines advise against extended thromboprophylaxis for patients who do not have suspected or confirmed VTE or other indications for anticoagulation. However, the guidelines recommend a careful individual risk-benefit assessment of VTE and bleeding probability, to determine whether an individual patient may merit ongoing prophylactic anticoagulation. A score such as IMPROVE DD can help identify those with potential benefit. Low-dose direct oral anticoagulants (DOACs) and low molecular weight heparins (LMVHs) were predominantly used, but the optimal duration (at least 14 days and up to 42 days) and the type of extended thromboprophylaxis is still under discussion. Future studies are therefore needed to clarify the VTE and bleeding outcomes in COVID-19 patients after hospital discharge. © 2022 Cǎlin Pop et al.

12.
J Cardiovasc Pharmacol Ther ; 28:10742484221145010, 2023.
Article in English | PubMed | ID: covidwho-2195068

ABSTRACT

Fondaparinux sodium is a chemically synthesized selective factor Xa inhibitor approved for the prevention and treatment of venous thromboembolic events, that is, deep vein thrombosis, pulmonary embolism, and superficial vein thrombosis, in acutely ill (including those affected by COVID-19 or cancer patients) and those undergoing surgeries. Since its approval in 2002, the efficacy and safety of fondaparinux is well demonstrated by many clinical studies, establishing the value of fondaparinux in clinical practice. Some of the advantages with fondaparinux are its chemical nature of synthesis, minimal risk of contamination, 100% absolute bioavailability subcutaneously, instant onset of action, a long half-life, direct renal excretion, fewer adverse reactions when compared with direct oral anticoagulants, and being an ideal alternative in conditions where oral anticoagulants are not approved for use or in patients intolerant to low molecular weight heparins (LMWH). In the last decade, the real-world use of fondaparinux has been explored in other conditions such as acute coronary syndromes, bariatric surgery, in patients developing vaccine-induced immune thrombotic thrombocytopenia (VITT) and in pregnant women with heparin-induced thrombocytopenia (HIT), or those intolerant to LMWH. The emerging data from these studies have culminated in recent updates in the guidelines that recommend the use of fondaparinux under various conditions. This paper aims to review the recent data and the subsequent updates in the recommendations of various guidelines on the use of fondaparinux sodium.

13.
Medicina Clínica (English Edition) ; 160(2):71-77, 2023.
Article in English | ScienceDirect | ID: covidwho-2181489

ABSTRACT

Objective To evaluate the effect of drug interactions with chronic direct oral anticoagulants (DOAC) on mortality in older atrial fibrillation (AF) patients during the Coronavirus disease 2019(COVID-19) pandemic. Methods We followed a total of 601 elderly patients (65 years of age) from the NOEL-Drug Registry cohort who were referred to a tertiary outpatient clinic between 9 March 2020 and 1 March 2021. We recorded clinical characteristics and medications for the last 3 months. In addition, all drug interactions were identified using Lexicomp®. Finally, we recorded retrospectively all death events, COVID-19 diagnosis, and relevant deaths from the database at the end of the study. According to logistic regression, we performed propensity score (PS) matching to reduce potential bias. Factors associated with total mortality in the 12 months were analyzed using multivariable Cox proportion hazard analysis. Results The mean age [standard deviation (SD)] was 74.5 (±6.9), and the male/female ratio was 337/264. The prevalence of total mortality was 16.9% (n=102). A total of 4472 drugs were analyzed for DOAC interaction. 81.8% of older AF patients were not at risk in terms of potential interaction. In the Cox proportional hazard model after PS-matching, previous DOAC use with class X interaction was associated with significantly higher mortality risk (adjusted hazard ratio: 2.745, 95% confidence interval: 1.465–5.172, p=0.004). Conclusions Our study showed that while most co-medications do not have significant interactions with DOACs, few serious drug interactions contribute to mortality in elderly patients with AF during the pandemic. Resumen Introducción Evaluar el efecto de las interacciones farmacológicas con anticoagulantes orales directos (ACOD) crónicos sobre la mortalidad en pacientes mayores con fibrilación auricular (FA) durante la pandemia de la enfermedad por coronavirus 2019 (COVID-19). Métodos Seguimos a un total de 601 pacientes ancianos (65años) de la cohorte NOEL-Drug Registry que fueron remitidos a una consulta externa de tercer nivel entre el 9 de marzo de 2020 y el 1 de marzo de 2021. Registramos las características clínicas y los medicamentos durante los últimos tres meses. Además, todas las interacciones medicamentosas se identificaron utilizando Lexicomp®. Finalmente, registramos retrospectivamente todos los eventos de muerte, el diagnóstico de COVID-19 y las muertes relevantes de la base de datos al final del estudio. De acuerdo con la regresión logística, realizamos un emparejamiento por puntaje de propensión (PP) para reducir el posible sesgo. Los factores asociados con la mortalidad total en los 12 meses se analizaron mediante análisis de riesgo de proporción de Cox multivariable. Resultados La edad media (desviación estándar [DE]) fue de 74,5 (±6,9) y la relación hombre/mujer, de 337/264. La prevalencia de mortalidad total fue del 16,9% (n=102). Se analizaron un total de 4.472 fármacos para determinar la interacción con ACOD. El 81,8% de los pacientes mayores con FA no estaban en riesgo en términos de interacción potencial. En el modelo de riesgos proporcionales de Cox después del emparejamiento por PP, el uso previo de ACOD con interacción X clase se asoció con un riesgo de mortalidad significativamente mayor (índice de riesgo ajustado: 2,745;intervalo de confianza del 95%: 1,465-5,172;p=0,004). Conclusión Nuestro estudio mostró que, si bien la mayoría de los medicamentos concomitantes no tienen interacciones significativas con los ACOD, pocas interacciones farmacológicas graves contribuyen a la mortalidad en pacientes de edad avanzada con fibrilación auricular durante la pandemia.

14.
Med Clin (Barc) ; 2022 Jul 15.
Article in English, Spanish | MEDLINE | ID: covidwho-2159538

ABSTRACT

OBJECTIVE: To evaluate the effect of drug interactions with chronic direct oral anticoagulants (DOAC) on mortality in older atrial fibrillation (AF) patients during the Coronavirus disease 2019(COVID-19) pandemic. METHODS: We followed a total of 601 elderly patients (65 years of age) from the NOEL-Drug Registry cohort who were referred to a tertiary outpatient clinic between 9 March 2020 and 1 March 2021. We recorded clinical characteristics and medications for the last 3 months. In addition, all drug interactions were identified using Lexicomp®. Finally, we recorded retrospectively all death events, COVID-19 diagnosis, and relevant deaths from the database at the end of the study. According to logistic regression, we performed propensity score (PS) matching to reduce potential bias. Factors associated with total mortality in the 12 months were analyzed using multivariable Cox proportion hazard analysis. RESULTS: The mean age [standard deviation (SD)] was 74.5 (±6.9), and the male/female ratio was 337/264. The prevalence of total mortality was 16.9% (n=102). A total of 4472 drugs were analyzed for DOAC interaction. 81.8% of older AF patients were not at risk in terms of potential interaction. In the Cox proportional hazard model after PS-matching, previous DOAC use with class X interaction was associated with significantly higher mortality risk (adjusted hazard ratio: 2.745, 95% confidence interval: 1.465-5.172, p=0.004). CONCLUSIONS: Our study showed that while most co-medications do not have significant interactions with DOACs, few serious drug interactions contribute to mortality in elderly patients with AF during the pandemic.

15.
Frontiers in Pharmacology ; 13, 2022.
Article in English | Web of Science | ID: covidwho-2163078

ABSTRACT

Anticoagulants are a potential treatment for the thrombotic complications resulting from COVID-19. We aimed to determine the association between anticoagulant use and adverse outcomes among hospitalized patients with COVID-19. We used data from the COVID-19 International Collaborative Research Project in South Korea from January to June 2020. We defined exposure using an intention-to-treat approach, with person-time classified as use or non-use of anticoagulants at cohort entry, and a time-varying approach. The primary outcome was all-cause, in-hospital mortality;the secondary outcome was a composite including respiratory outcomes, cardiovascular outcomes, venous thromboembolism, major bleeding, and intensive care unit admission. Cox proportional hazards models estimated adjusted hazard ratios (HRs) of the outcomes comparing use versus non-use of anticoagulants. Our cohort included 2,677 hospitalized COVID-19 patients, of whom 24 received anticoagulants at cohort entry. Users were older and had more comorbidities. The crude incidence rate (per 1,000 person-days) of mortality was 5.83 (95% CI: 2.80, 10.72) among anticoagulant users and 1.36 (95% CI: 1.14, 1.59) for non-users. Crude rates of the composite outcome were 3.20 (95% CI: 1.04, 7.47) and 1.80 (95% CI: 1.54, 2.08), respectively. Adjusted HRs for mortality (HR: 1.12, 95% CI: 0.48, 2.64) and the composite outcome (HR: 0.79, 95% CI: 0.28, 2.18) were inconclusive. Although our study was not able to draw conclusions on anticoagulant effectiveness for COVID-19 outcomes, these results can contribute to future knowledge syntheses of this important question. Our study demonstrated that the dynamic pandemic environment may have important implications for observational studies of COVID-19 treatment effectiveness.

16.
Lupus Science & Medicine ; 9(Suppl 3):A84-A85, 2022.
Article in English | ProQuest Central | ID: covidwho-2161974

ABSTRACT

BackgroundPregnant women with antiphospholipid antibodies and/or lupus have higher rates of adverse pregnancy outcomes (APOs), such as fetal loss and preterm birth due to severe preeclampsia (PE) or placental insufficiency (PI). The presence of lupus anticoagulant (LAC) is the strongest predictor of an APO. At present, there is no effective treatment for women with these high-risk pregnancies, but in an animal model that mimics this human condition we found that TNF-α was a critical downstream effector of abnormal placental development and fetal damage, and that TNF-α blockade normalized placentation and spiral artery remodeling, and rescued pregnancies. We sought to determine whether TNF-α blockade during pregnancy, added to a regimen of heparin and low dose aspirin, reduces the rate of APOs in women with clinical APS and LAC.MethodsThe IMPACT Study (IMProve Pregnancy in APS with Certolizumab Therapy) is an open label single-stage Phase II trial to evaluate the effect of certolizumab, a TNF-α inhibitor that does not cross the placenta and has been shown to be well tolerated in pregnancy, to reduce the risk of adverse outcomes in this population. Patients with APS and LAC are referred to IMPACT by their physicians, consented and screened remotely by a study investigator, and medication is sent to the patient. They are treated with certolizumab from gestational week 8 through 28. Investigators contact patients every 2 weeks and receive medical reports and research blood samples monthly. The primary outcome is a composite of two APOs associated with poor placentation: fetal death >10 WG or severe preeclampsia/placental insufficiency requiring delivery prior to 34 weeks gestation. The target sample size is 45 evaluable subjects. We hypothesize that the rate of the primary outcome in these pregnancies will be reduced from ~40% based on historical data to 20% with certolizumab.ResultsSince May 2017 and despite the COVID-19 pandemic, we have enrolled 41 patients from ten states and 1 Canadian province. Characteristics: 56% previous PE or PI <34 weeks requiring delivery, 83% previous fetal death >10 weeks;61% thrombosis and/or stroke and 24% SLE in addition to APS. During the trial, no new clinical manifestations of SLE have been observed in participants who did not carry the SLE diagnosis. There were no instances of new anti-DNA antibodies or increases in autoantibody titres in those patients who were anti-DNA antibody positive. ACL or anti-β2GPI antibody titres did not change during the trial. There have been no serious adverse events attributable to the study medication.ConclusionWe are successfully using a "rare disease study” approach to conduct the first trial of a biologic therapy to prevent pregnancy complications in women with APS and LAC. Certolizumab appears to be safe in this small trial. Certolizumab appears to be safe so far in this small trial. IMPACT must be completed before we can draw any conclusions about efficacy, and its results must be confirmed in a future study.AcknowledgementsNIAMS, Lupus Research institute, Lupus Foundation of AmericaClinicalTrials. gov Identifier: NCT03152058Lay SummaryPregnancies in patients with antiphospholipid syndrome who have a lupus anticoagulant in their blood have a high likelihood of ending in fetal death or very premature delivery because of poor placental development and preeclampsia. At present, there is no effective treatment for women with these high-risk pregnancies, but our work in an animal model that mimics this human condition shows that blockade of TNF-α, a pivotal mediator of inflammation, prevents adverse outcomes. Our study will determine whether treatment during pregnancy with certolizumab, a TNF-α inhibitor that does not cross the placenta, reduces the rate of poor pregnancy outcomes in women with clinical antiphospholipid syndrome;and, if successful, it will provide a new approach to protecting pregnancies in women with antiphospholipid syndrome and a rationale for trials of TNF-α blockade in women with other conditions, like SLE, who are a risk for preeclampsia or placental insufficiency.

17.
Computational Approaches for Novel Therapeutic and Diagnostic Designing to Mitigate SARS-CoV2 Infection: Revolutionary Strategies to Combat Pandemics ; : 77-95, 2022.
Article in English | Scopus | ID: covidwho-2149124

ABSTRACT

The Coronavirus disease 2019 (COVID-19) pandemic caused by the novel severe acute respiratory syndrome Coronavirus 2 (SARS CoV-2) has created a never-before-seen problem for humanity. The world was pushed into a position where we needed to identify the effective drugs for a disease that has unknown characteristics in the early 2020s. SARS CoV-2 Virology research suggested that several drugs could be the potential targets. Remdesivir was the first drug that was shown to have promising results in in vitro studies. Remdesivir became the first antiviral drug approved by USFDA for the management of COVID-19. But later studies show equivocal results. For this entirely new disease, we are still searching the perfect drug. Many existing drugs have been repurposed (steroids, anticoagulation, hydroxychloroquine) with varying success. Many new drugs have been researched for the management of this menace. In this review, we will discuss the mechanisms, uses, dosage, duration, and adverse effects of drugs used in COVID-19. © 2022 Elsevier Inc. All rights reserved.

18.
Gastroenterology Res ; 15(5): 263-267, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-2145515

ABSTRACT

Background: Coronavirus disease 2019 (COVID-19) can lead to ventilator-dependent chronic respiratory failure and a need for tube feeding. Percutaneous endoscopic gastrostomy (PEG) placement provides more sustainable longer-term enteral access with fewer side effects compared to the long-term nasogastric tube placement. Bleeding is a recognized complication of PEG placement, and many COVID-19 patients are on antiplatelets/anticoagulants, yet minimal data exist on the safety of PEG tube placement in this context. Methods: A retrospective chart review identified patients who underwent PEG placement between January 2020 and January 2021 at a single institution. Success was defined as PEG placement and use to provide enteral nutrition with no complications requiring removal within 4 weeks. Results: Thirty-six patients with and 104 age- and sex-matched patients without COVID-19 infection were included. More COVID-19 patients were obese, on anticoagulants, had low serum albumin levels and had a tracheostomy in place. Of those patients, 8.3% with COVID-19 developed PEG-related complications compared to 16.3% without (P = 0.28). PEG success rates in patients with and without COVID-19 were similar at 97.2% and 92.3%, respectively (P = 0.44). Conclusion: PEG tube placement is comparatively safe in COVID-19 patients who need long-term enteral access.

19.
Medical News of North Caucasus ; 17(3):314-316, 2022.
Article in Russian | EMBASE | ID: covidwho-2145418

ABSTRACT

The severe course of COVID-19 infection is usually complicated by hypercoagulability caused by excessive thrombin production and suppression of fibrinolysis, bleeding, in this situations, is rarely develops. The article presents clinical cases of the development of spontaneous hematomas and intra-abdominal bleeding in patients with severe COVID-19. Considering the risk of the development of spontaneous bleeding patients with COVID-19 need constant monitoring of the hemostasis system and ability to provide emergency surgical care must be present in infectious diseases hospitals. Copyright © 2022 Stavropol State Medical University. All rights reserved.

20.
Assam Journal of Internal Medicine ; 11(2):54-57, 2021.
Article in English | ProQuest Central | ID: covidwho-2144106

ABSTRACT

A 24-year-old female presented with blurring of vision, chemosis, protrusion of eyeball, restriction of movements of right eye, numbness over the right side of the face with severe headache, stiffness of neck, and fever of 2 days duration. She gives a history of recent Covid-19 infection 3 weeks back. She was treated symptomatically and recovered fully. On examination, there was proptosis, chemosis, third, fourth, fifth, and sixth nerve palsy on the right side, and nuchal rigidity. She was started on broad spectrum antibiotics, analgesics, anticoagulant, and prophylactic antifungal thinking in line of post-Covid orbital cellulitis or mucormycosis. Her investigations revealed raised total leucocyte count and erythrocyte sedimentation rate with normal ultrasound abdomen and chest X-ray. Blood culture and culture of nasal swab and oral cavity for fungus were sterile. Contrast-enhanced magnetic resonance imaging brain, orbit, and sinus showed proptosis, myofascial edema, superior ophthalmic vein thrombosis, right cavernous sinus and deep cervical vein thrombosis, sphenoid and bilateral ethmoid sinusitis with narrow lumen of the internal jugular vein. She responded very well to the treatment. Her inflammatory parameters came down drastically and clinically, she started opening her eyes and ophthalmoplegia subsided within a week. By the 10th day she was asymptomatic. Repeat MRI showed reduction of proptosis, myofascial edema with partial recanalization of right superior ophthalmic vein, right cavernous sinus, and right deep cervical vein. She was discharged on injectable anticoagulant and antibiotics for another 10 days.

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