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Søgeord (remdesivir) valgt.
43 emner vises.
Journal of Infectious Diseases, 25.04.2024
Tilføjet 25.04.2024
Abstract Background Although antivirals remain important for the treatment COVID-19, methods to assess treatment efficacy are lacking. Here, we investigated the impact of remdesivir on viral dynamics and their contribution to understanding antiviral efficacy in the multicenter ACTT-1 clinical trial that randomized patients to remdesivir or placebo.Methods Longitudinal specimens collected during hospitalization from a substudy of 642 COVID-19 patients were measured for viral RNA (upper respiratory tract and plasma), viral nucleocapsid antigen (serum), and host immunologic markers. Associations with clinical outcomes and response to therapy were assessed.Results Higher baseline plasma viral loads were associated with poorer clinical outcomes, and decreases in viral RNA and antigen in blood but not the upper respiratory tract correlated with enhanced benefit from remdesivir. The treatment effect of remdesivir was most pronounced in patients with elevated baseline nucleocapsid antigen levels: the recovery rate ratio was 1.95 (95%CI 1.40-2.71) for levels >245 pg/ml vs 1.04 (95%CI 0.76-1.42) for levels
Læs mere Tjek på PubMedBMC Infectious Diseases, 19.04.2024
Tilføjet 19.04.2024
Abstract Background and purpose The COVID-19 pandemic has presented unprecedented public health challenges worldwide. Understanding the factors contributing to COVID-19 mortality is critical for effective management and intervention strategies. This study aims to unlock the predictive power of data collected from personal, clinical, preclinical, and laboratory variables through machine learning (ML) analyses. Methods A retrospective study was conducted in 2022 in a large hospital in Abadan, Iran. Data were collected and categorized into demographic, clinical, comorbid, treatment, initial vital signs, symptoms, and laboratory test groups. The collected data were subjected to ML analysis to identify predictive factors associated with COVID-19 mortality. Five algorithms were used to analyze the data set and derive the latent predictive power of the variables by the shapely additive explanation values. Results Results highlight key factors associated with COVID-19 mortality, including age, comorbidities (hypertension, diabetes), specific treatments (antibiotics, remdesivir, favipiravir, vitamin zinc), and clinical indicators (heart rate, respiratory rate, temperature). Notably, specific symptoms (productive cough, dyspnea, delirium) and laboratory values (D-dimer, ESR) also play a critical role in predicting outcomes. This study highlights the importance of feature selection and the impact of data quantity and quality on model performance. Conclusion This study highlights the potential of ML analysis to improve the accuracy of COVID-19 mortality prediction and emphasizes the need for a comprehensive approach that considers multiple feature categories. It highlights the critical role of data quality and quantity in improving model performance and contributes to our understanding of the multifaceted factors that influence COVID-19 outcomes.
Læs mere Tjek på PubMedKuo‐Chuan Hung, Wei‐Ting Wang, I‐Yin Hung, I‐Wen Chen
Journal of Medical Virology, 3.04.2024
Tilføjet 3.04.2024
Clinical Infectious Diseases, 2.04.2024
Tilføjet 2.04.2024
Abstract Background We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with Coronavirus Disease 2019 (COVID-19) receiving remdesivir plus standard of care (SoC) compared to SoC alone (control), as an association was noted in some cohort studies and disproportionality analyses of safety databases.Methods This post-hoc safety analysis is based on data from the multicenter, randomized, open-label, controlled DisCoVeRy trial in hospitalized patients with COVID-19 (NCT04315948). Any first AE occurring between randomization and day 29 in the modified intention-to-treat (mITT) population randomized to either remdesivir or control group was considered. Analysis was performed using Kaplan-Meier survival curves and Kaplan-Meier estimates were calculated for event rates.Results Cardiac AEs were reported in 46 (11.2%) of 410 and 48 (11.3%) of 423 patients in the mITT population (n = 833) enrolled in the remdesivir and control groups, respectively. The difference between both groups was not significant (HR 1.0, 95% CI 0.7-1.5, p = 0.98), even when evaluating serious and non-serious cardiac AEs separately. The majority of reports in both groups were of arrhythmic nature (remdesivir, 84.8%; control, 83.3%) and were associated with a favorable outcome. There was no significant difference between remdesivir and control groups in the occurrence of different cardiac AE subclasses, including arrhythmic events (HR 1.1, 95% CI: 0.7-1.7, p = 0.68).Conclusions Remdesivir treatment was not associated with an increased risk of cardiac AEs, whether serious or not, and regardless of AE severity, compared to control, in patients hospitalized with moderate or severe COVID-19. This is consistent with the results of other randomized controlled trials and meta-analyses.
Læs mere Tjek på PubMedWen-Fang TangYu-Hsiu ChangCheng-Chin LinJia-Rong JhengChung-Fan HsiehYuan-Fan ChinTein-Yao ChangJin-Ching LeePo-Huang LiangChia-Yi LinGuan-Hua LinJie-Yun CaiYu-Li ChenYuan-Siao ChenShan-Ko TsaiPing-Cheng LiuChuen-Mi YangTolou ShadbahrJing TangYu-Lin HsuChih-Heng HuangLing-Yu WangCheng Cheung ChenJyh-Hwa KauYi-Jen HungHsin-Yi LeeWen-Chieh WangHui-Ping TsaiJim-Tong Horng1Research Center for Emerging Viral Infections, College of Medicine, Chang Gung University, Kweishan, Taoyuan, Taiwan2Institute of Preventive Medicine, National Defense Medical Center, New Taipei, Taiwan3Department of Microbiology and Immunology, National Defense Medical Center, Taipei, Taiwan4Institute of Biochemical Sciences, National Taiwan University, Taipei, Taiwan5Department of Biochemistry and Molecular Biology, College of Medicine, Chang Gung University, Kweishan, Taoyuan, Taiwan6Department of Neurology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan7Department of Pathology and Graduate Institute of Pathology and Parasitology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan8Department of Marine Biotechnology and Resources, National Sun Yat-sen University, Kaohsiung, Taiwan9Department of Biotechnology, Kaohsiung Medical University, Kaohsiung, Taiwan10Institute of Biological Chemistry, Academia Sinica, Taipei, Taiwan11Research Center for Industry of Human Ecology and Research Center for Chinese Herbal Medicine, Graduate Institute of Health Industry Technology, Chang Gung University of Science and Technology, Taoyuan, Taiwan12Department of Mathematics and Statistics, University of Helsinki, Helsinki, Finland13Graduate Institute of Medical Science, National Defense Medical Center, Taipei, Taiwan14Division of Medical Oncology, Chang Gung Memorial Hospital, Taoyuan, Taiwan15Institute of Biotechnology and Pharmaceutical Research, Value-Added MedChem Innovation Center, National Health Research Institutes, Zhunan, Miaoli, Taiwan16Molecular Infectious Disease Research Center, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan, Miguel Angel Martinez
Antimicrobial Agents And Chemotherapy, 6.03.2024
Tilføjet 6.03.2024
Haruka Shida, Maki Komamine, Kazuhiro Kajiyama, Takashi Waki, Hotaka Maruyama, Yoshiaki Uyama
PLoS One Infectious Diseases, 27.01.2024
Tilføjet 27.01.2024
by Haruka Shida, Maki Komamine, Kazuhiro Kajiyama, Takashi Waki, Hotaka Maruyama, Yoshiaki Uyama Objective Prescription trends and patterns of anti-COVID-19 drugs in hospitalized patients were examined based on real world data to understand the use of anti-COVID-19 drugs in clinical practice in Japan. Design The longitudinal and cross-sectional study was conducted utilizing data from January 1, 2019 to December 31, 2021 of the MID-NET® medical information database, which stored the electronic medical records, administrative claim data, and diagnosis procedure combination data of patients in Japan. Participants Hospitalized patients with a COVID-19-related diagnosis who received at least one anti-COVID-19 drug between April 1, 2020 and December 31, 2021. Exposures The following 14 drugs were included in this study: remdesivir, baricitinib, combination product of casirivimab and imdevimab, favipiravir, dexamethasone, ivermectin, azithromycin, nafamostat mesylate, camostat mesylate, ciclesonide, tocilizumab, sarilumab, combination product of lopinavir and ritonavir, and hydroxychloroquine. Results We identified 5,717 patients hospitalized with COVID-19 and prescribed at least one anti-COVID-19 drug. The entire cohort generally included patients over 41–50 years and more males. The most common prescription pattern was dexamethasone monotherapy (22.9%), followed by the concomitant use of remdesivir and dexamethasone (15.0%), azithromycin monotherapy (15.0%), remdesivir monotherapy (10.2%), and nafamostat mesylate monotherapy (8.5%). However, an often prescribed anti-COVID-19 drug differed depending on the period. Conclusions and relevance This study revealed the real-world situation of anti-COVID-19 drug prescriptions in hospitalized COVID-19 patients in Japan. A prescribed drug would depend on the latest scientific evidence, such as efficacy, safety, and approval status, at the time of prescription. Understanding the prescription of anti-COVID-19 drugs will be important for providing the most up-to-date treatments to patients and evaluating the benefit and/or risk of anti-COVID-19 drugs based on the utilization of an electronic medical record database.
Læs mere Tjek på PubMedClinical Infectious Diseases, 4.01.2024
Tilføjet 4.01.2024
Abstract Within a multi-state clinical cohort, SARS-CoV-2 antiviral prescribing patterns were evaluated from April 2022-June 2023 among non-hospitalized SARS-CoV-2-infected patients with risk factors for severe COVID-19. Among 3,247 adults, only 31.9% were prescribed an antiviral agent (87.6% nirmatrelvir/ritonavir, 11.9% molnupiravir, 0.5% remdesivir), highlighting the need to identify and address treatment barriers.
Læs mere Tjek på PubMedBMC Infectious Diseases, 2.01.2024
Tilføjet 2.01.2024
Abstract Background The health crisis due to Covid-19 led to the search for therapeutics that could improve the evolution of the disease. Remdesivir, an antiviral that interferes with viral replication, was one of the first to be used for the treatment of this pathology. Objective To determine clinical course and mortality of patients with severe SARS-CoV‐2 pneumonia treated with remdesivir, in comparison of those who didn’t receive the medication. Patients and methods Retrospective cohort study, with medical records review of COVID-19 patients, between August 2020 and August 2021. The subjects were divided into two groups, those who received remdesivir before or after admission to intensive care and those who didn’t. The primary outcome variable was mortality in intensive care. Results Of 214 subjects included, 109 (50,9%) received remdesivir. The median of days for the drug administration was 8 (2-20), IQR: 3. The bivariate analysis prove that the use of remdesivir was related with lower risk of develop Acute Respiratory Distress Syndrome (ARDS) (p = 0,019; OR: 0,521) and lower requirement of mechanical ventilation (p = 0,006; OR:0,450). Additionally, patients treated with remdesivir develop less kidney injury (p = 0,009; OR: 0,441). There was a total of 82 deaths, 29 (26,6%) in the remdesivir group and 53 (50,5%) in the control group [p
Læs mere Tjek på PubMedInfection, 21.12.2023
Tilføjet 21.12.2023
Abstract Purpose Preliminary evidence suggests a potential effect of antiviral medication used during the acute COVID-19 phase for preventing long-COVID. This review investigates if having received pharmacological treatment during acute SARS-CoV-2 infection may reduce the risk of long-COVID. Methods MEDLINE, CINAHL, PubMed, EMBASE, Web of Science databases, as well as medRxiv/bioRxiv preprint servers were searched up to July 15th, 2023. Articles comparing the presence of long-COVID symptoms between individuals who received or not a specific medication, particularly antivirals, during the acute phase of SARS-CoV-2 infection were included. Methodological quality was assessed using the Newcastle–Ottawa Scale or Cochrane’s Risk of Bias (Rob) tool. Results From 517 studies identified, 6 peer-reviewed studies and one preprint met all inclusion criteria. The sample included 2683 (n = 4) hospitalized COVID-19 survivors and 307,409 (n = 3) non-hospitalized patients. The methodological quality was high in 71% of studies (n = 5/7). Two studies investigating the effects of Nirmaltrevir/Ritonavir and three studies the effect of Remdesivir reported conflicting results on effectiveness for preventing long-COVID. Three studies investigating the effects of other medication such as Dexamethasone (n = 2) or Metformin (n = 1) found positive results of these medications for preventing long-COVID. Conclusion Available evidence about the effect of medication treatment with antivirals during acute COVID-19 and reduced risk of developing long-COVID is conflicting. Heterogeneous evidence suggests that Remdesivir or Nirmaltrevir/Ritonavir could have a potential protective effect for long-COVID. A limited number of studies demonstrated a potential benefit of other medications such as Dexamethasone or Metformin, but more studies are needed.
Læs mere Tjek på PubMedInfection, 19.12.2023
Tilføjet 19.12.2023
Abstract Purpose Preliminary evidence suggests a potential effect of antiviral medication used during the acute COVID-19 phase for preventing long-COVID. This review investigates if having received pharmacological treatment during acute SARS-CoV-2 infection may reduce the risk of long-COVID. Methods MEDLINE, CINAHL, PubMed, EMBASE, Web of Science databases, as well as medRxiv/bioRxiv preprint servers were searched up to July 15th, 2023. Articles comparing the presence of long-COVID symptoms between individuals who received or not a specific medication, particularly antivirals, during the acute phase of SARS-CoV-2 infection were included. Methodological quality was assessed using the Newcastle–Ottawa Scale or Cochrane’s Risk of Bias (Rob) tool. Results From 517 studies identified, 6 peer-reviewed studies and one preprint met all inclusion criteria. The sample included 2683 (n = 4) hospitalized COVID-19 survivors and 307,409 (n = 3) non-hospitalized patients. The methodological quality was high in 71% of studies (n = 5/7). Two studies investigating the effects of Nirmaltrevir/Ritonavir and three studies the effect of Remdesivir reported conflicting results on effectiveness for preventing long-COVID. Three studies investigating the effects of other medication such as Dexamethasone (n = 2) or Metformin (n = 1) found positive results of these medications for preventing long-COVID. Conclusion Available evidence about the effect of medication treatment with antivirals during acute COVID-19 and reduced risk of developing long-COVID is conflicting. Heterogeneous evidence suggests that Remdesivir or Nirmaltrevir/Ritonavir could have a potential protective effect for long-COVID. A limited number of studies demonstrated a potential benefit of other medications such as Dexamethasone or Metformin, but more studies are needed.
Læs mere Tjek på PubMedJournal of the American Medical Association, 6.12.2023
Tilføjet 6.12.2023
In Reply We thank Drs Mathew and Feldmann for their comments on the results of ACTIV-1. We agree that mortality is a very important clinical outcome, but designing a trial such as ACTIV-1 to have sufficient power to detect an effect on mortality was challenging in June 2020, when data on clinical outcomes of severe COVID-19 were in flux. Indeed, the design of ACTIV-1 was heavily influenced by the results of ACTT-1, the initial placebo-controlled trial of remdesivir, which showed evidence of improved time to recovery but not improved mortality.
Læs mere Tjek på PubMedBMC Infectious Diseases, 11.11.2023
Tilføjet 11.11.2023
Abstract Background Clinical evidence suggests that pregnant women are more vulnerable to COVID-19, since they are at increased risk for disease progression and for obstetric complications, such as premature labor, miscarriage, preeclampsia, cesarean delivery, fetal growth restriction and perinatal death. Despite this evidence, pregnant women are often excluded from clinical trials, resulting in limited knowledge on COVID-19 management. The aim of this systematic review and meta-analysis is to provide better evidence on the efficacy and safety of available COVID-19 treatment in pregnant women. Methods Four authors searched major electronic databases from inception until 1 st November-2022 for controlled trials/observational studies, investigating outcomes after the administration of anti-SARS-CoV-2 treatments in pregnant women affected by COVID-19. The analyses investigated the cumulative incidence of delivery and maternal outcomes in pregnant women, comparing those taking active medication vs standard care. Risk ratios (RRs) with 95% confidence intervals were calculated. Statistical significance was assessed using the random effects model and inverse-variance method. This systematic review and meta-analysis was conducted in accordance with the updated 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol has been registered in Prospero (number registration: CRD42023397445). Results From initially 937 non duplicate records, we assessed the full texts of 40 articles, finally including ten studies. In six studies, including 1627 patients, the use of casirivimab/imdevimab (CAS/IMD), remdesivir, and IFN-alpha 2b significantly decreased the need of cesarean section ((RR = 0.665; 95%CI: 0.491–0.899; p = 0.008; I 2 = 19.5%;) (Table 1, (Fig. 1). Treatments did not decrease the risk of preterm delivery, admission to neonatal ICU, or stillbirth/perinatal loss (p-values > 0.50 for all these outcomes) and did not prevent the progression of disease towards severe degrees (k = 8; 2,374 pregnant women; RR = 0.778; 95%CI: 0.550–1.099; p = 0.15; I 2 = 0%). Moreover, the use of medications during pregnancy did not modify the incidence of maternal death in two studies (Table 2). Conclusions To our analysis, CAS/IMD, remdesivir, and IFN alpha 2b reduced the number of cesarean sections but demonstrated no effect on disease progression and other obstetric and COVID-19 related outcomes. The inability to evaluate the influence of viral load on illness development in pregnant women was attributed to lack of data. In our systematic review, no major side effects were reported. Though, it is essential for the medical community to focus more on clinical trials and less on episodic case reports and case series, with standardization of fetal and maternal outcomes.
Læs mere Tjek på PubMedBMC Infectious Diseases, 9.11.2023
Tilføjet 9.11.2023
Abstract Background Clinical evidence suggests that pregnant women are more vulnerable to COVID-19, since they are at increased risk for disease progression and for obstetric complications, such as premature labor, miscarriage, preeclampsia, cesarean delivery, fetal growth restriction and perinatal death. Despite this evidence, pregnant women are often excluded from clinical trials, resulting in limited knowledge on COVID-19 management. The aim of this systematic review and meta-analysis is to provide better evidence on the efficacy and safety of available COVID-19 treatment in pregnant women. Methods Four authors searched major electronic databases from inception until 1 st November-2022 for controlled trials/observational studies, investigating outcomes after the administration of anti-SARS-CoV-2 treatments in pregnant women affected by COVID-19. The analyses investigated the cumulative incidence of delivery and maternal outcomes in pregnant women, comparing those taking active medication vs standard care. Risk ratios (RRs) with 95% confidence intervals were calculated. Statistical significance was assessed using the random effects model and inverse-variance method. This systematic review and meta-analysis was conducted in accordance with the updated 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol has been registered in Prospero (number registration: CRD42023397445). Results From initially 937 non duplicate records, we assessed the full texts of 40 articles, finally including ten studies. In six studies, including 1627 patients, the use of casirivimab/imdevimab (CAS/IMD), remdesivir, and IFN-alpha 2b significantly decreased the need of cesarean section ((RR = 0.665; 95%CI: 0.491–0.899; p = 0.008; I 2 = 19.5%;) (Table 1, (Fig. 1). Treatments did not decrease the risk of preterm delivery, admission to neonatal ICU, or stillbirth/perinatal loss (p-values > 0.50 for all these outcomes) and did not prevent the progression of disease towards severe degrees (k = 8; 2,374 pregnant women; RR = 0.778; 95%CI: 0.550–1.099; p = 0.15; I 2 = 0%). Moreover, the use of medications during pregnancy did not modify the incidence of maternal death in two studies (Table 2). Conclusions To our analysis, CAS/IMD, remdesivir, and IFN alpha 2b reduced the number of cesarean sections but demonstrated no effect on disease progression and other obstetric and COVID-19 related outcomes. The inability to evaluate the influence of viral load on illness development in pregnant women was attributed to lack of data. In our systematic review, no major side effects were reported. Though, it is essential for the medical community to focus more on clinical trials and less on episodic case reports and case series, with standardization of fetal and maternal outcomes.
Læs mere Tjek på PubMedBMC Infectious Diseases, 9.11.2023
Tilføjet 9.11.2023
Abstract Background Clinical evidence suggests that pregnant women are more vulnerable to COVID-19, since they are at increased risk for disease progression and for obstetric complications, such as premature labor, miscarriage, preeclampsia, cesarean delivery, fetal growth restriction and perinatal death. Despite this evidence, pregnant women are often excluded from clinical trials, resulting in limited knowledge on COVID-19 management. The aim of this systematic review and meta-analysis is to provide better evidence on the efficacy and safety of available COVID-19 treatment in pregnant women. Methods Four authors searched major electronic databases from inception until 1 st November-2022 for controlled trials/observational studies, investigating outcomes after the administration of anti-SARS-CoV-2 treatments in pregnant women affected by COVID-19. The analyses investigated the cumulative incidence of delivery and maternal outcomes in pregnant women, comparing those taking active medication vs standard care. Risk ratios (RRs) with 95% confidence intervals were calculated. Statistical significance was assessed using the random effects model and inverse-variance method. This systematic review and meta-analysis was conducted in accordance with the updated 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol has been registered in Prospero (number registration: CRD42023397445). Results From initially 937 non duplicate records, we assessed the full texts of 40 articles, finally including ten studies. In six studies, including 1627 patients, the use of casirivimab/imdevimab (CAS/IMD), remdesivir, and IFN-alpha 2b significantly decreased the need of cesarean section ((RR = 0.665; 95%CI: 0.491–0.899; p = 0.008; I 2 = 19.5%;) (Table 1, (Fig. 1). Treatments did not decrease the risk of preterm delivery, admission to neonatal ICU, or stillbirth/perinatal loss (p-values > 0.50 for all these outcomes) and did not prevent the progression of disease towards severe degrees (k = 8; 2,374 pregnant women; RR = 0.778; 95%CI: 0.550–1.099; p = 0.15; I 2 = 0%). Moreover, the use of medications during pregnancy did not modify the incidence of maternal death in two studies (Table 2). Conclusions To our analysis, CAS/IMD, remdesivir, and IFN alpha 2b reduced the number of cesarean sections but demonstrated no effect on disease progression and other obstetric and COVID-19 related outcomes. The inability to evaluate the influence of viral load on illness development in pregnant women was attributed to lack of data. In our systematic review, no major side effects were reported. Though, it is essential for the medical community to focus more on clinical trials and less on episodic case reports and case series, with standardization of fetal and maternal outcomes.
Læs mere Tjek på PubMedBMC Infectious Diseases, 9.11.2023
Tilføjet 9.11.2023
Abstract Background Given the widespread prevalence of the coronavirus disease 2019 (COVID-19), oral and neck examinations tend to be avoided in patients with suspected or confirmed COVID-19. This might delay the diagnosis of conditions such as Lemierre’s syndrome, which involves symptoms resembling COVID-19-related throat manifestations. Case presentation A 24-year-old man without any underlying conditions was diagnosed with COVID-19 7 days before presentation. He was admitted to another hospital 1 day before presentation with severe COVID-19 and suspected bacterial pneumonia; accordingly, he was started on treatment with remdesivir and meropenem. Owing to bacteremic complications, the patient was transferred to our hospital for intensive care. On the sixth day, the patient experienced hemoptysis; further, a computed tomography (CT) scan revealed new pulmonary artery pseudoaneurysms. Successful embolization was performed to achieve hemostasis. In blood cultures conducted at the previous hospital, Fusobacterium nucleatum was isolated, suggesting a cervical origin of the infection. A neck CT scan confirmed a peritonsillar abscess and left internal jugular vein thrombus; accordingly, he was diagnosed with Lemierre’s syndrome. The treatment was switched to ampicillin/sulbactam, based on the drug susceptibility results. After 6 weeks of treatment, the patient completely recovered without complications. Conclusion This case highlights the significance of thorough oral and neck examinations in patients with suspected or diagnosed COVID-19 for the detection of throat and neck symptoms caused by other conditions.
Læs mere Tjek på PubMedBMC Infectious Diseases, 9.11.2023
Tilføjet 9.11.2023
Abstract Background Given the widespread prevalence of the coronavirus disease 2019 (COVID-19), oral and neck examinations tend to be avoided in patients with suspected or confirmed COVID-19. This might delay the diagnosis of conditions such as Lemierre’s syndrome, which involves symptoms resembling COVID-19-related throat manifestations. Case presentation A 24-year-old man without any underlying conditions was diagnosed with COVID-19 7 days before presentation. He was admitted to another hospital 1 day before presentation with severe COVID-19 and suspected bacterial pneumonia; accordingly, he was started on treatment with remdesivir and meropenem. Owing to bacteremic complications, the patient was transferred to our hospital for intensive care. On the sixth day, the patient experienced hemoptysis; further, a computed tomography (CT) scan revealed new pulmonary artery pseudoaneurysms. Successful embolization was performed to achieve hemostasis. In blood cultures conducted at the previous hospital, Fusobacterium nucleatum was isolated, suggesting a cervical origin of the infection. A neck CT scan confirmed a peritonsillar abscess and left internal jugular vein thrombus; accordingly, he was diagnosed with Lemierre’s syndrome. The treatment was switched to ampicillin/sulbactam, based on the drug susceptibility results. After 6 weeks of treatment, the patient completely recovered without complications. Conclusion This case highlights the significance of thorough oral and neck examinations in patients with suspected or diagnosed COVID-19 for the detection of throat and neck symptoms caused by other conditions.
Læs mere Tjek på PubMedBMC Infectious Diseases, 7.11.2023
Tilføjet 7.11.2023
Abstract Background Given the widespread prevalence of the coronavirus disease 2019 (COVID-19), oral and neck examinations tend to be avoided in patients with suspected or confirmed COVID-19. This might delay the diagnosis of conditions such as Lemierre’s syndrome, which involves symptoms resembling COVID-19-related throat manifestations. Case presentation A 24-year-old man without any underlying conditions was diagnosed with COVID-19 7 days before presentation. He was admitted to another hospital 1 day before presentation with severe COVID-19 and suspected bacterial pneumonia; accordingly, he was started on treatment with remdesivir and meropenem. Owing to bacteremic complications, the patient was transferred to our hospital for intensive care. On the sixth day, the patient experienced hemoptysis; further, a computed tomography (CT) scan revealed new pulmonary artery pseudoaneurysms. Successful embolization was performed to achieve hemostasis. In blood cultures conducted at the previous hospital, Fusobacterium nucleatum was isolated, suggesting a cervical origin of the infection. A neck CT scan confirmed a peritonsillar abscess and left internal jugular vein thrombus; accordingly, he was diagnosed with Lemierre’s syndrome. The treatment was switched to ampicillin/sulbactam, based on the drug susceptibility results. After 6 weeks of treatment, the patient completely recovered without complications. Conclusion This case highlights the significance of thorough oral and neck examinations in patients with suspected or diagnosed COVID-19 for the detection of throat and neck symptoms caused by other conditions.
Læs mere Tjek på PubMedInfection, 5.11.2023
Tilføjet 5.11.2023
Abstract Purpose Lung transplant recipients are at increased risk of severe disease following infection with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) due to high-dose immunosuppressive drugs and the lung is the main organ affected by Coronavirus disease 2019 (COVID-19). Several studies have confirmed increased SARS-CoV-2-related mortality and morbidity in patients living with lung allografts; however, detailed immunological studies of patients with SARS-CoV-2 infection in the early phase following transplantation remain scarce. Methods We investigated patients who were infected with SARS-CoV-2 in the early phase (18–103 days) after receiving double-lung allografts (n = 4, LuTx) in comparison to immunocompetent patients who had not received solid organ transplants (n = 88, noTx). We analyzed SARS-CoV-2-specific antibody responses against the SARS-CoV-2 spike and nucleocapsid proteins using enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), and immunoblot assays. T cell responses were investigated using Elispot assays. Results One LuTx patient suffered from persistent infection with fatal outcome 122 days post-infection despite multiple interventions including remdesivir, convalescent plasma, and the monoclonal antibody bamlanivimab. Two patients experienced clinically mild disease with prolonged viral shedding (47 and 79 days), and one patient remained asymptomatic. Antibody and T cell responses were significantly reduced or undetectable in all LuTx patients compared to noTx patients. Conclusion Patients in the early phase following lung allograft transplantation are vulnerable to infection with SARS-CoV-2 due to impaired immune responses. This patient population should be vaccinated before LuTx, protected from infection post–LuTx, and in case of infection treated generously with currently available interventions.
Læs mere Tjek på PubMedInfection, 4.11.2023
Tilføjet 4.11.2023
Abstract Purpose Lung transplant recipients are at increased risk of severe disease following infection with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) due to high-dose immunosuppressive drugs and the lung is the main organ affected by Coronavirus disease 2019 (COVID-19). Several studies have confirmed increased SARS-CoV-2-related mortality and morbidity in patients living with lung allografts; however, detailed immunological studies of patients with SARS-CoV-2 infection in the early phase following transplantation remain scarce. Methods We investigated patients who were infected with SARS-CoV-2 in the early phase (18–103 days) after receiving double-lung allografts (n = 4, LuTx) in comparison to immunocompetent patients who had not received solid organ transplants (n = 88, noTx). We analyzed SARS-CoV-2-specific antibody responses against the SARS-CoV-2 spike and nucleocapsid proteins using enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), and immunoblot assays. T cell responses were investigated using Elispot assays. Results One LuTx patient suffered from persistent infection with fatal outcome 122 days post-infection despite multiple interventions including remdesivir, convalescent plasma, and the monoclonal antibody bamlanivimab. Two patients experienced clinically mild disease with prolonged viral shedding (47 and 79 days), and one patient remained asymptomatic. Antibody and T cell responses were significantly reduced or undetectable in all LuTx patients compared to noTx patients. Conclusion Patients in the early phase following lung allograft transplantation are vulnerable to infection with SARS-CoV-2 due to impaired immune responses. This patient population should be vaccinated before LuTx, protected from infection post–LuTx, and in case of infection treated generously with currently available interventions.
Læs mere Tjek på PubMedInfection, 4.11.2023
Tilføjet 4.11.2023
Abstract Purpose Lung transplant recipients are at increased risk of severe disease following infection with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) due to high-dose immunosuppressive drugs and the lung is the main organ affected by Coronavirus disease 2019 (COVID-19). Several studies have confirmed increased SARS-CoV-2-related mortality and morbidity in patients living with lung allografts; however, detailed immunological studies of patients with SARS-CoV-2 infection in the early phase following transplantation remain scarce. Methods We investigated patients who were infected with SARS-CoV-2 in the early phase (18–103 days) after receiving double-lung allografts (n = 4, LuTx) in comparison to immunocompetent patients who had not received solid organ transplants (n = 88, noTx). We analyzed SARS-CoV-2-specific antibody responses against the SARS-CoV-2 spike and nucleocapsid proteins using enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), and immunoblot assays. T cell responses were investigated using Elispot assays. Results One LuTx patient suffered from persistent infection with fatal outcome 122 days post-infection despite multiple interventions including remdesivir, convalescent plasma, and the monoclonal antibody bamlanivimab. Two patients experienced clinically mild disease with prolonged viral shedding (47 and 79 days), and one patient remained asymptomatic. Antibody and T cell responses were significantly reduced or undetectable in all LuTx patients compared to noTx patients. Conclusion Patients in the early phase following lung allograft transplantation are vulnerable to infection with SARS-CoV-2 due to impaired immune responses. This patient population should be vaccinated before LuTx, protected from infection post–LuTx, and in case of infection treated generously with currently available interventions.
Læs mere Tjek på PubMedSeyed Majid Mousavi Movahed, Hamed Akhavizadegan, Fatemeh Dolatkhani, Samaneh Akbarpour, Seyed Aria Nejadghaderi, Morvarid Najafi, Parmida Sadat Pezeshki, Akram Khalili Noushabadi, Hoomaan Ghasemi
PLoS One Infectious Diseases, 11.10.2023
Tilføjet 11.10.2023
by Seyed Majid Mousavi Movahed, Hamed Akhavizadegan, Fatemeh Dolatkhani, Samaneh Akbarpour, Seyed Aria Nejadghaderi, Morvarid Najafi, Parmida Sadat Pezeshki, Akram Khalili Noushabadi, Hoomaan Ghasemi Background Acute kidney injury is a complication of COVID-19 and is associated with severity. Despite no specific antiviral treatment strategy, lopinavir/ritonavir and remdesivir have been used. Data on the association between AKI and receiving antiviral agents with outcomes in hospitalized patients with COVID-19 is scarce. We aimed to determine the incidence of AKI and its outcomes in COVID-19 patients with and without antiviral medications. Methods We conducted a retrospective study on hospitalized adult patients with SARS-CoV-2 infection in a tertiary center. The primary endpoint was determining mortality, intensive care unit (ICU) admission, and length of hospitalization affected by AKI development using antiviral agents. The logistic regression method was used to explore the predictive effects of AKI and antiviral therapy on composite outcomes (i.e., mortality, ICU admission, and prolonged hospitalization) in four defined groups by AKI development/not and utilizing antivirals/not. We used IBM SPSS version 24.0 software for statistical analysis. Results Out of 833 COVID-19 patients who were included, 75 patients were treated with antiviral agents and developed AKI. There was a significant difference in the occurrence of AKI and using antiviral medications (p = 0.001). Also, the group using antiviral agents and the development of AKI had the highest rate of preexisting hypertension (p = 0.002). Of note, the group of patients who used antiviral agents and also developed AKI had the most remarkable association with our composite outcome (p
Læs mere Tjek på PubMedBMC Infectious Diseases, 10.10.2023
Tilføjet 10.10.2023
Abstract Background Remdesivir is considered to be a specific drug for treating coronavirus disease 2019. This systematic review aims to evaluate the clinical efficacy and risk of remdesivir alone and in combination with other drugs. Research design and methods The PubMed, Embase, SCIE, Cochrane Library, and American Clinical trial Center databases were searched up to 1 April 2022 to identify. Randomized controlled trials (RCTs) and observational studies comparing the efficacy of remdesivir monotherapy and combination therapy with that of control drugs. Results Ten RCTs and 32 observational studies were included in the analysis. Regarding the primary outcome, remdesivir use reduced mortality in patients with severe COVID-19 (RR = 0.57, 95% CI (0.48,0.68)) and shortened the time to clinical improvement (MD = -2.51, 95% CI (-2.75, -2.28)). Regarding other clinical outcomes, remdesivir use was associated with improved clinical status (RR = 1.08, 95%CI (1.01, 1.17)). Regarding safety outcomes, remdesivir use did not cause liver or kidney damage (RR = 0.87, 95%CI (0.68, 1.11)) (RR = 0.88, 95%CI (0.70,1.10)). Compared with remdesivir alone, remdesivir combined with other drugs (e.g., steroids, favipiravir, and convalescent plasma) had no effect on mortality. Conclusion The use of remdesivir can help to reduce the mortality of patients with severe COVID-19 and shorten the time to clinical improvement. There was no benefit of remdesivir combination therapy for other clinical outcomes. Trial registration PROSPERO registration number: CRD42022322859.
Læs mere Tjek på PubMedJournal of the American Medical Association, 9.10.2023
Tilføjet 9.10.2023
This JAMA Patient Page describes current medications available for outpatient treatment of COVID-19 (nirmatrelvir-ritonavir, remdesivir, and molnupiravir), their effectiveness, and how to obtain them.
Læs mere Tjek på PubMedInfection, 4.10.2023
Tilføjet 4.10.2023
Abstract Background The Borna disease virus (BoDV-1) is an emerging zoonotic virus causing severe and mostly fatal encephalitis in humans. Methods and Results A local cluster of fatal BoDV-1 encephalitis cases was detected in the same village three years apart affecting two children. While the first case was diagnosed late in the course of disease, a very early diagnosis and treatment attempt facilitated by heightened awareness was achieved in the second case. Therapy started as early as day 12 of disease. Antiviral therapy encompassed favipiravir and ribavirin, and, after bioinformatic modelling, also remdesivir. As the disease is immunopathogenetically mediated, an intensified anti-inflammatory therapy was administered. Following initial impressive clinical improvement, the course was also fatal, although clearly prolonged. Viral RNA was detected by qPCR in tear fluid and saliva, constituting a possible transmission risk for health care professionals. Highest viral loads were found post mortem in the olfactory nerve and the limbic system, possibly reflecting the portal of entry for BoDV-1. Whole exome sequencing in both patients yielded no hint for underlying immunodeficiency. Full virus genomes belonging to the same cluster were obtained in both cases by next-generation sequencing. Sequences were not identical, indicating viral diversity in natural reservoirs. Specific transmission events or a common source of infection were not found by structured interviews. Patients lived 750m apart from each other and on the fringe of the settlement, a recently shown relevant risk factor. Conclusion Our report highlights the urgent necessity of effective treatment strategies, heightened awareness and early diagnosis. Gaps of knowledge regarding risk factors, transmission events, and tailored prevention methods become apparent. Whether this case cluster reflects endemicity or a geographical hot spot needs further investigation.
Læs mere Tjek på PubMedBMC Infectious Diseases, 3.10.2023
Tilføjet 3.10.2023
Abstract Purpose To investigate the clinical impact of three available antivirals for early COVID-19 treatment in a large real-life cohort. Methods Between January and October 2022 all outpatients tested positive for SARS-CoV-2 referring to IRCCS S. Orsola hospital treated with an early antiviral therapy were enrolled. A comparison between patients treated with nirmatrelvir/ritonavir (NTV/r), molnupiravir (MPV) and remdesivir (RDV) was conducted in term of indications and outcome. To account for differences between treatment groups a propensity score analysis was performed. After estimating the weights, we fitted a survey-weighted Cox regression model with inverse-probability weighting with hospital admission/death versus clinical recovery as the primary outcome. Results Overall 1342 patients were enrolled, 775 (57.8%), 360 (26.8%) and 207 (15.4%) in MPV, NTV/r and RDV group, respectively. Median age was 73 (59–82) years, male sex was 53.4%. Primary indication was immunosuppression (438, 32.6%), the median time from symptom onset to drug administration was 3 [2–4] days. Overall, clinical recovery was reached in 96.9% of patients, with hospital admission rate of 2.6%. No significant differences were found in clinical recovery nor hospitalization. Cox regression showed a decreased probability of hospital admission/ death among prior vaccinated patients compared with unvaccinated (HR 0.31 [95%CI 0.14–0.70], p = 0.005]). No difference in hospitalization rates in early treatment compared to late treatment were found. Conclusions No differences among MPV, NTV/r and RDV in terms of clinical recovery or hospitalization were found. Patients not vaccinated had a significant increased risk of hospitalization.
Læs mere Tjek på PubMedSamuel M Brown, Christina E Barkauskas, Birgit Grund, Shweta Sharma, Andrew N Phillips, Lindsay Leither, Ithan D Peltan, Michael Lanspa, Daniel L Gilstrap, Ahmad Mourad, Kathleen Lane, Jeremy R Beitler, Alexis L Serra, Ivan Garcia, Eyad Almasri, Mohamed Fayed, Kinsley Hubel, Estelle S Harris, Elizabeth A Middleton, Macy A G Barrios, Kusum S Mathews, Neha N Goel, Samuel Acquah, Jarrod Mosier, Cameron Hypes, Elizabeth Salvagio Campbell, Akram Khan, Catherine L Hough, Jennifer G Wilson, Joseph E Levitt, Abhijit Duggal, Siddharth Dugar, Andrew J Goodwin, Charles Terry, Peter Chen, Sam Torbati, Nithya Iyer, Uriel S Sandkovsky, Nicholas J Johnson, Bryce R H Robinson, Michael A Matthay, Neil R Aggarwal, Ivor S Douglas, Jonathan D Casey, Manuel Hache-Marliere, J Georges Youssef, William Nkemdirim, Brad Leshnower, Omar Awan, Sonal Pannu, Darragh Shane O'Mahony, Prasad Manian, J W Awori Hayanga, Glenn W Wortmann, Bruno M Tomazini, Robert F Miller, Jens-Ulrik Jensen, Daniel D Murray, Nina A Bickell, Jigna Zatakia, Sarah Burris, Elizabeth S Higgs, Ven Natarajan, Robin L Dewar, Adam Schechner, Nayon Kang, Alejandro Arenas-Pinto, Fleur Hudson, Adit A Ginde, Wesley H Self, Angela J Rogers, Cathryn F Oldmixon, Haley Morin, Adriana Sanchez, Amy C Weintrob, Alexandre Biasi Cavalcanti, Anne Davis-Karim, Nicole Engen, Eileen Denning, B Taylor Thompson, Annetine C Gelijns, Virginia Kan, Victoria J Davey, Jens D Lundgren, Abdel G Babiker, James D Neaton, H Clifford Lane, ACTIV-3b/Therapeutics for Severely Ill Inpatients with COVID-19 (TESICO) Study Group
Lancet Respiratory Medicine, 31.08.2023
Tilføjet 31.08.2023
Among patients with COVID-19-associated acute hypoxaemic respiratory failure, aviptadil did not significantly improve clinical outcomes up to day 90 when compared with placebo. The smaller than planned sample size for the remdesivir trial did not permit definitive conclusions regarding safety or efficacy.
Læs mere Tjek på PubMedClinical Infectious Diseases, 21.08.2023
Tilføjet 21.08.2023
AbstractResistance of SARS-CoV-2 to antivirals was shown to develop in immunocompromised individuals receiving remdesivir. We describe an immunocompromised patient who was treated with repeated and prolonged courses of nirmatrelvir and developed de-novo E166V/L50F mutations in the Mpro region. These mutations were associates with clinical and virological treatment failure.
Læs mere Tjek på PubMedClinical Infectious Diseases, 10.08.2023
Tilføjet 10.08.2023
AbstractBackgroundImmunocompromised patients are at high risk of severe COVID-19 and death, yet treatment strategies for immunocompromised patients hospitalized for COVID-19 reflect variations in clinical practice. This comparative effectiveness study investigated the effect of remdesivir treatment on inpatient mortality among immunocompromised patients hospitalized for COVID-19 across all variants of concern (VOC) periods.MethodsData for immunocompromised patients hospitalized for COVID-19 between December 2020 and April 2022 were extracted from the US PINC AI Healthcare Database. Patients initiating remdesivir within two days of hospitalization were matched 1:1 using propensity score matching with replacement to patients who did not receive remdesivir during their hospitalization for COVID-19. Additional matching criteria included admission month, age group, and hospital. Cox Proportional Hazards models were used to examine the effect of remdesivir on risk of 14- and 28-day mortality during VOC periods.ResultsA total of 19,184 remdesivir patients were matched to 11,213 non-remdesivir patients. Overall, 11.1% and 17.7% of remdesivir patients died within 14 and 28 days, respectively, compared with 15.4% and 22.4% of non-remdesivir patients. Remdesivir was associated with a reduction in mortality at 14 days (hazard ratio [95% confidence interval]: 0.70 [0.62–0.78]) and 28 days (0.75 [0.68–0.83]). Survival benefit remained significant during the Pre-Delta, Delta, and Omicron time-periods.ConclusionsPrompt initiation of remdesivir in immunocompromised patients hospitalized for COVID-19 is associated with significant survival benefit across all variant waves. These findings provide much-needed evidence relating to the effectiveness of a foundational treatment for hospitalized COVID-19 patients among a high-risk population.
Læs mere Tjek på PubMedYoshiko Ishisaka, Tadao Aikawa, Aaqib Malik, Polydoros N. Kampaktsis, Alexandros Briasoulis, Toshiki Kuno
Journal of Medical Virology, 5.08.2023
Tilføjet 5.08.2023
Journal of Infectious Diseases, 21.07.2023
Tilføjet 21.07.2023
AbstractBackgroundUncertainty over the therapeutic benefit provided by parenteral remdesivir in COVID-19 has resulted in varying treatment guidelines.MethodsIn a multicenter open label, controlled, adaptive, pharmacometric platform trial, low-risk adult patients with early symptomatic COVID-19 were randomized to one of eight treatment arms including intravenous remdesivir (200 mg followed by 100 mg daily for five days) or no study drug. The primary outcome was the rate of viral clearance (estimated under a linear model fit to the daily log10 viral densities, days 0-7) in standardized duplicate oropharyngeal swab eluates, in a modified intention-to-treat population (mITT). This ongoing adaptive trial is registered at ClinicalTrials.gov (NCT05041907).ResultsThe two study arms enrolled 131 patients (remdesivir n = 67, no study drug n = 64) and estimated viral clearance rates from a median of 18 swab samples per patient (a total of 2356 qPCRs). Under the linear model, compared with the contemporaneous control arm (no study drug), remdesivir accelerated mean estimated SARS-CoV-2 viral clearance by 42% (95% credible interval [CI] 18 to 73).InterpretationParenteral remdesivir accelerates viral clearance in early symptomatic COVID-19. Pharmacometric assessment of therapeutics using the described method can rapidly and efficiently determine in vivo clinical efficacy.
Læs mere Tjek på PubMedJournal of Infectious Diseases, 19.07.2023
Tilføjet 19.07.2023
AbstractBackgroundRemdesivir is approved for the treatment of COVID-19 in non-hospitalized and hospitalized adult and pediatric patients. Here we present SARS-CoV-2 resistance analyses from the Phase 3 ACTT-1 randomized placebo-controlled trial conducted in adult participants hospitalized with COVID-19.MethodsSwab samples were collected at baseline and longitudinally through Day 29. SARS-CoV-2 genomes were sequenced using next-generation sequencing. Phenotypic analysis was conducted directly on participant virus isolates and/or using SARS-CoV-2 subgenomic replicons expressing mutations identified in the Nsp12 target gene.ResultsAmong participants with both baseline and post-baseline sequencing data, emergent Nsp12 substitutions were observed in 12/31 (38.7%) and 12/30 (40.0%) participants in the remdesivir and placebo arms, respectively. No emergent Nsp12 substitutions in the remdesivir arm were observed in more than one participant. Phenotyping showed low to no change in susceptibility to remdesivir relative to wild-type Nsp12 reference for the substitutions tested: A16V (0.8-fold change in EC50), P323L+V792I (2.2-fold), C799F (2.5-fold), K59N (1.0-fold), and K59N+V792I (3.4-fold).ConclusionsThe similar rate of emerging Nsp12 substitutions in remdesivir and placebo arms and the minimal change in remdesivir susceptibility among tested substitutions support a high barrier to remdesivir resistance development in COVID-19 patients.
Læs mere Tjek på PubMedCandace C. Fuller, Austin Cosgrove, Mayura Shinde, Edward Rosen, Katie Haffenreffer, Christian Hague, Laura E. McLean, Jonathan Perlin, Russell E. Poland, Kenneth E. Sands, Natasha Pratt, Patricia Bright, Richard Platt, Noelle M. Cocoros, Sarah K. Dutcher
PLoS One Infectious Diseases, 12.07.2023
Tilføjet 12.07.2023
by Candace C. Fuller, Austin Cosgrove, Mayura Shinde, Edward Rosen, Katie Haffenreffer, Christian Hague, Laura E. McLean, Jonathan Perlin, Russell E. Poland, Kenneth E. Sands, Natasha Pratt, Patricia Bright, Richard Platt, Noelle M. Cocoros, Sarah K. Dutcher We described care received by hospitalized children with COVID-19 or multi-system inflammatory syndrome (MIS-C) prior to the 2021 COVID-19 Omicron variant surge in the US. We identified hospitalized children 6 years old (54% COVID-19, 70% MIS-C). High-risk conditions included asthma (14% COVID-19, 11% MIS-C), and obesity (9% COVID-19, 10% MIS-C). Pulmonary complications in children with COVID-19 included viral pneumonia (24%) and acute respiratory failure (11%). In reference to children with COVID-19, those with MIS-C had more hematological disorders (62% vs 34%), sepsis (16% vs 6%), pericarditis (13% vs 2%), myocarditis (8% vs 1%). Few were ventilated or died, but some required oxygen support (38% COVID-19, 45% MIS-C) or intensive care (42% COVID-19, 69% MIS-C). Treatments included: methylprednisolone (34% COVID-19, 75% MIS-C), dexamethasone (25% COVID-19, 15% MIS-C), remdesivir (13% COVID-19, 5% MIS-C). Antibiotics (50% COVID-19, 68% MIS-C) and low-molecular weight heparin (17% COVID-19, 34% MIS-C) were frequently administered. Markers of illness severity among hospitalized children with COVID-19 prior to the 2021 Omicron surge are consistent with previous studies. We report important trends on treatments in hospitalized children with COVID-19 to improve the understanding of real-world treatment patterns in this population.
Læs mere Tjek på PubMedBMC Infectious Diseases, 12.07.2023
Tilføjet 12.07.2023
Abstract Background Remdesivir is widely used for treatment of SARS-CoV-2 pneumonia. The aim of this study was to evaluate the characteristics of patients with moderate-to-severe COVID-19 treated with remdesivir, and their outcomes during hospitalization. Methods This retrospective observational multicenter study included consecutive patients, hospitalized for moderate-to-severe COVID-19 (September 2020—September 2021), who were treated with remdesivir. Results One thousand four patients were enrolled, all with onset of symptoms occurring less than 10 days before starting remdesivir; 17% of patients had 4 or more concomitant diseases. Remdesivir was well tolerated, adverse drug reactions (ADRs) being reported in 2.3% of patients. In-hospital death occurred in 80 patients (8.0%). The median timing of the first remdesivir dose was 5 days after symptom onset. The following endpoints did not differ according to the time span from the onset of symptoms to the first dose: length of hospitalization, in-hospital death, composite outcome (in-hospital death and/or endotracheal intubation). Advanced age, number of comorbidities ≥ 4, and severity of respiratory failure at admission were associated with poor in-hospital outcomes. Conclusion In a real-world setting, remdesivir proved to be a safe and well-tolerated treatment for moderate-to-severe COVID-19. In patients receiving remdesivir less than 3 or 5 days from the onset of SARS-CoV-2 symptoms, mortality and the need for mechanical ventilation did not differ from the rest of the sample.
Læs mere Tjek på PubMedTiffany A. Walker, Alex D. Truong, Aerica Summers, Adviteeya N. Dixit, Felicia C. Goldstein, Ihab Hajjar, Melvin R. Echols, Matthew C. Woodruff, Erica D. Lee, Seema Tekwani, Kelley Carroll, Ignacio Sanz, F. Eun-Hyung Lee, Jenny E. Han
PLoS One Infectious Diseases, 10.07.2023
Tilføjet 10.07.2023
by Tiffany A. Walker, Alex D. Truong, Aerica Summers, Adviteeya N. Dixit, Felicia C. Goldstein, Ihab Hajjar, Melvin R. Echols, Matthew C. Woodruff, Erica D. Lee, Seema Tekwani, Kelley Carroll, Ignacio Sanz, F. Eun-Hyung Lee, Jenny E. Han Background The impact of COVID-19 severity on development of long-term sequelae remains unclear, and symptom courses are not well defined. Methods This ambidirectional cohort study recruited adults with new or worsening symptoms lasting ≥3 weeks from confirmed SARS-CoV-2 infection between August 2020–December 2021. COVID-19 severity was defined as severe for those requiring hospitalization and mild for those not. Symptoms were collected using standardized questionnaires. Multivariable logistical regression estimated odds ratios (OR) and 95% confidence intervals (CI) for associations between clinical variables and symptoms. Results Of 332 participants enrolled, median age was 52 years (IQR 42–62), 233 (70%) were female, and 172 (52%) were African American. Antecedent COVID-19 was mild in 171 (52%) and severe in 161 (48%). In adjusted models relative to severe cases, mild COVID-19 was associated with greater odds of fatigue (OR:1.83, CI:1.01–3.31), subjective cognitive impairment (OR:2.76, CI:1.53–5.00), headaches (OR:2.15, CI:1.05–4.44), and dizziness (OR:2.41, CI:1.18–4.92). Remdesivir treatment was associated with less fatigue (OR:0.47, CI:0.26–0.86) and fewer participants scoring >1.5 SD on PROMIS Cognitive scales (OR:0.43, CI:0.20–0.92). Fatigue and subjective cognitive impairment prevalence was higher 3–6 months after COVID-19 and persisted (fatigue OR:3.29, CI:2.08–5.20; cognitive OR:2.62, CI:1.67–4.11). Headache was highest at 9–12 months (OR:5.80, CI:1.94–17.3). Conclusions Mild antecedent COVID-19 was associated with highly prevalent symptoms, and those treated with remdesivir developed less fatigue and cognitive impairment. Sequelae had a delayed peak, ranging 3–12 months post infection, and many did not improve over time, underscoring the importance of targeted preventative measures.
Læs mere Tjek på PubMedBMC Infectious Diseases, 9.07.2023
Tilføjet 9.07.2023
Abstract Background Remdesivir is widely used for treatment of SARS-CoV-2 pneumonia. The aim of this study was to evaluate the characteristics of patients with moderate-to-severe COVID-19 treated with remdesivir, and their outcomes during hospitalization. Methods This retrospective observational multicenter study included consecutive patients, hospitalized for moderate-to-severe COVID-19 (September 2020—September 2021), who were treated with remdesivir. Results One thousand four patients were enrolled, all with onset of symptoms occurring less than 10 days before starting remdesivir; 17% of patients had 4 or more concomitant diseases. Remdesivir was well tolerated, adverse drug reactions (ADRs) being reported in 2.3% of patients. In-hospital death occurred in 80 patients (8.0%). The median timing of the first remdesivir dose was 5 days after symptom onset. The following endpoints did not differ according to the time span from the onset of symptoms to the first dose: length of hospitalization, in-hospital death, composite outcome (in-hospital death and/or endotracheal intubation). Advanced age, number of comorbidities ≥ 4, and severity of respiratory failure at admission were associated with poor in-hospital outcomes. Conclusion In a real-world setting, remdesivir proved to be a safe and well-tolerated treatment for moderate-to-severe COVID-19. In patients receiving remdesivir less than 3 or 5 days from the onset of SARS-CoV-2 symptoms, mortality and the need for mechanical ventilation did not differ from the rest of the sample.
Læs mere Tjek på PubMedClinical Infectious Diseases, 25.06.2023
Tilføjet 25.06.2023
AbstractBackgroundDeath within a specified time window following a positive SARS-CoV-2 test is used by some agencies for attributing death to COVID-19. With omicron variants, widespread immunity, and asymptomatic screening, there is cause to re-evaluate COVID-19 death attribution methods and develop tools to improve case ascertainment.MethodsAll patients who died following microbiologically-confirmed SARS-CoV-2 in the Veterans Health Administration (VA) and at Tufts Medical Center (TMC) were identified. Records of selected vaccinated VA patients with positive tests in 2022, and of all TMC patients with positive tests in 2021-22, were manually reviewed to classify deaths as COVID-19-related (either directly caused by or contributed to), focused on deaths within 30 days. Logistic regression was used to develop and validate a surveillance model for identifying deaths in which COVID-19 was causal or contributory.ResultsAmong vaccinated VA patients who died within 30 days after a positive test in January-February, 2022, death was COVID-19-related in 103/150 (69%) of cases (55% causal, 14% contributory). In June-August, 2022, death was COVID-19-related in 70/150 (47%) of cases (22% causal, 25% contributory). Similar results were seen among the 71 patients who died at TMC. A model including hypoxemia, remdesivir, and anti-inflammatory drugs had PPV 0.82-0.95 and NPV 0.64-0.83.ConclusionsBy mid-2022, “death within 30 days” did not provide an accurate estimate of COVID-19-related death in two US healthcare systems with routine admission screening. Hypoxemia and use of antiviral and anti-inflammatory drugs – variables feasible for reporting to public health agencies - would improve classification of death as COVID-19-related.
Læs mere Tjek på PubMedClinical Infectious Diseases, 21.06.2023
Tilføjet 21.06.2023
AbstractBackgroundPatients with antibody deficiency respond poorly to COVID-19 vaccination and are at risk of severe or prolonged infection. They are given long-term immunoglobulin replacement therapy (IRT) prepared from healthy donor plasma to confer passive immunity against infection. Following widespread COVID-19 vaccination alongside natural exposure, we hypothesised that immunoglobulin preparations will now contain neutralising SARS-CoV-2 spike antibodies which confer protection against COVID-19 disease and may help to treat chronic infection.MethodsWe evaluated anti-SARS-CoV-2 spike antibody in a cohort of patients before and after immunoglobulin infusion. Neutralising capacity of patient samples and immunoglobulin products was assessed using in vitro pseudo-virus and live-virus neutralisation assays, the latter investigating multiple batches against current circulating omicron variants. We describe the clinical course of nine patients started on IRT during treatment of COVID-19.ResultsIn 35 individuals with antibody deficiency established on IRT, median anti-spike antibody titre increased from 2123 to 10600 U/ml post-infusion, with corresponding increase in pseudo-virus neutralisation titres to levels comparable to healthy donors. Testing immunoglobulin products directly in the live-virus assay confirmed neutralisation, including of BQ1.1 and XBB variants, but with variation between immunoglobulin products and batches.Initiation of IRT alongside Remdesivir in patients with antibody deficiency and prolonged COVID-19 infection (median 189 days, maximum over 900 days with an ancestral viral strain) resulted in clearance of SARS-CoV-2 virus at a median of 20 days.ConclusionsImmunoglobulin preparations now contain neutralising anti-SARS-CoV-2 antibodies which are transmitted to patients and help to treat COVID-19 in individuals with failure of humoral immunity.
Læs mere Tjek på PubMedPham, H. T., Mai-Phan, T.-A., Vu, A. K., Truong, T. H., Tran, M.-H.
BMJ Open, 10.06.2023
Tilføjet 10.06.2023
ObjectivesThis study investigated remdesivir’s clinical use to provide direct evidence of effectiveness for a low-middle income Asian setting. DesignA one-to-one propensity score matching retrospective cohort study. SettingA tertiary hospital with COVID-19 treatment facilities in Vietnam. ParticipantsA total of 310 patients in standard of care (SoC) group were matched with 310 patients in SoC+remdesivir (SoC+R) group. Primary and secondary outcome measuresThe primary outcome was time to critical progression, defined as all-cause mortality or critical illness. The secondary outcomes were length of oxygen therapy/ventilation and need for invasive mechanical ventilation. Outcome reports were presented as HR, OR or effect difference with 95% CI. ResultsPatients receiving remdesivir had a lower risk for mortality or critical illness (HR=0.68, 95% CI 0.47 to 0.96, p=0.030). Remdesivir was not associated with a shorter length of oxygen therapy/ventilation (effect difference –0.17 days, 95% CI –1.29 to 0.96, p=0.774). The need for invasive mechanical ventilation was lower in SoC+R group (OR=0.57, 95% CI 0.38 to 0.86, p=0.007). ConclusionsThis study’s results showing remdesivir’s benefits in non-critical patients with COVID-19 may be extrapolated to other similar low-middle income countries, allowing more regimens for limited resource areas and reducing poor outcomes and equity gap worldwide.
Læs mere Tjek på PubMedInfection, 24.05.2023
Tilføjet 24.05.2023
Abstract Purpose Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is currently the major threat for immunocompromised individuals. The course of COVID-19 in lung transplant recipients in the Omicron era remains unknown. The aim of the study was to assess outcome and associated factors in lung transplant recipients in a German-wide multicenter approach. Methods All affected individuals from January 1st to March 20th, 2022 from 8 German centers during the Omicron wave were collected. Baseline characteristics and antiviral measures were associated with outcome. Results Of 218 patients with PCR-proven SARS-CoV-2 infection 166 patients (76%) received any early (
Læs mere Tjek på PubMedBMC Infectious Diseases, 9.05.2023
Tilføjet 9.05.2023
Abstract The emergence of resistance to antiviral drugs increasingly used to treat SARS-CoV-2 infections has been recognised as a significant threat to COVID-19 control. In addition, some SARS-CoV-2 variants of concern appear to be intrinsically resistant to several classes of these antiviral agents. Therefore, there is a critical need for rapid recognition of clinically relevant polymorphisms in SARS-CoV-2 genomes associated with significant reduction of drug activity in virus neutralisation experiments. Here we present SABRes, a bioinformatic tool, which leverages on expanding public datasets of SARS-CoV-2 genomes and allows detection of drug resistance mutations in consensus genomes as well as in viral subpopulations. We have applied SABRes to detect resistance-conferring mutations in 25,197 genomes generated over the course of the SARS-CoV-2 pandemic in Australia and identified 299 genomes containing resistance conferring mutations to the five antiviral therapeutics that retain effectiveness against currently circulating strains of SARS-CoV-2 – Sotrovimab, Bebtelovimab, Remdesivir, Nirmatrelvir and Molnupiravir. These genomes accounted for a 1.18% prevalence of resistant isolates discovered by SABRes, including 80 genomes with resistance conferring mutations found in viral subpopulations. Timely recognition of these mutations within subpopulations is critical as these mutations can provide an advantage under selective pressure and presents an important step forward in our ability to monitor SARS-CoV-2 drug resistance.
Læs mere Tjek på PubMedDavide Marangoni, Roberta Maria Antonello, Marco Coppi, Marianna Palazzo, Luca Nassi, Noemi Streva, Laura Povolo, Francesca Malentacchi, Lorenzo Zammarchi, Gian Maria Rossolini, Alessandro Maria Vannucchi, Alessandro Bartoloni, Michele Spinicci
International Journal of Infectious Diseases, 5.05.2023
Tilføjet 5.05.2023
The development of vaccines and early treatments against SARS-CoV-2, including monoclonal antibodies, intravenous remdesivir and orally administered molnupiravir and nirmatrelvir/ritonavir, have completely rewritten the course of Coronavirus disease 2019 (COVID-19) for most patients during the early phase of the disease. In particular, both nirmatrelvir/ritonavir and molnupiravir, which act as protease inhibitor and competitive substrate of viral RNA-dependent-RNA-polymerase, respectively, demonstrated to be effective in reducing the risk of hospitalisation or death among at-risk adults in phase 3 clinical trials [1].
Læs mere Tjek på PubMedBMC Infectious Diseases, 5.05.2023
Tilføjet 5.05.2023
Abstract Background Shorter duration of symptoms before remdesivir has been associated with better outcomes. Our goal was to evaluate variables associated with the need of ICU admission in a cohort of hospitalized patients for COVID-19 under remdesivir including the period from symptoms onset to remdesivir. Methods We conducted a retrospective multicentric study analysing all patients admitted with COVID-19 in 9 Spanish hospitals who received treatment with remdesivir in October 2020. The main outcome was the need of ICU admission after 24 h of the first dose of remdesivir. Results In our cohort of 497 patients, the median of days from symptom onset to remdesivir was 5 days, and 70 of them (14.1%) were later admitted into ICU. The clinical outcomes associated with ICU admission were days from symptoms onset (5 vs. 6; p = 0.023), clinical signs of severe disease (respiratory rate, neutrophil count, ferritin levels and very-high mortality rate in SEIMC-Score) and the use of corticosteroids and anti-inflammatory drugs before ICU. The only variable significatively associated with risk reduction in the Cox-regression analyses was ≤ 5 days from symptoms onset to RDV (HR: 0.54, CI95%: 0.31–0.92; p = 0.024). Conclusion For patients admitted to the hospital with COVID-19, the prescription of remdesivir within 5 days from symptoms onset diminishes the need of ICU admission.
Læs mere Tjek på PubMedAlain Amstutz, Benjamin Speich, France Mentré, Corina Silvia Rueegg, Drifa Belhadi, Lambert Assoumou, Charles Burdet, Srinivas Murthy, Lori Elizabeth Dodd, Yeming Wang, Kari A O Tikkinen, Florence Ader, Maya Hites, Maude Bouscambert, Mary Anne Trabaud, Mike Fralick, Todd C Lee, Ruxandra Pinto, Andreas Barratt-Due, Fridtjof Lund-Johansen, Fredrik Müller, Olli P O Nevalainen, Bin Cao, Tyler Bonnett, Alexandra Griessbach, Ala Taji Heravi, Christof Schönenberger, Perrine Janiaud, Laura Werlen, Soheila Aghlmandi, Stefan Schandelmaier, Yazdan Yazdanpanah, Dominique Costagliola, Inge Christoffer Olsen, Matthias Briel
Lancet Respiratory Medicine, 4.05.2023
Tilføjet 4.05.2023
This individual patient data meta-analysis showed that remdesivir reduced mortality in patients hospitalised with COVID-19 who required no or conventional oxygen support, but was underpowered to evaluate patients who were ventilated when receiving remdesivir. The effect size of remdesivir in patients with more respiratory support or acquired immunity and the cost-effectiveness of remdesivir remain to be further elucidated.
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