Serious Adverse Events – Page 16 – Communicable Diseases Research

Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis

COVID-19 치료를 위한 약리학적 중재의 비교 효능 및 안전성: 체계적인 검토 및 네트워크 메타 분석

Meta-Analysis

Published on 2020-12-302022-08-13
Journal: PLoS Medicine [Category] Biology and Life Sciences, MERS, meta-analysis, 임상,

Compassionate Use of Tocilizumab for Treatment of SARS-CoV-2 Pneumonia

SARS-CoV-2 폐렴 치료를 위한 토실리주맙의 자비로운 사용

Article

Published on 2020-12-152022-09-11
Journal: Clinical Infectious Diseases: An Official Publicat [Category] MERS, SARS, 신약개발, 진단, 치료기술,

[키워드] acute respiratory distress acute respiratory distress syndrome acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Adverse adverse events anti-IL-6R antigen receptor appear approved benefit C-reactive protein C-reactive protein (CRP chimeric antigen receptor clinical and laboratory parameters clinical trials compassionate use coronavirus COVID-19 CRP cytokine Cytokine storm death Decline declines dose drug Drug administration Efficacy event examined Follow-up food Food and Drug Administration hospitalized patient hospitalized patients IL-6 IL-6R Inflammation interleukin interleukin 6 Intubated laboratory parameter Laboratory parameters mechanical ventilation morbidity morbidity and mortality Mortality occurred offer outcomes oxygen Oxygen requirements oxygen saturation oxygen saturations oxygen support pathogenic Patient patients patients with SARS-CoV-2 Placebo placebo-controlled Pneumonia predominant Preliminary data profiles proof Randomized rationale reducing required respiratory respiratory distress Respiratory distress syndrome SARS-CoV-2 SARS-CoV-2 pneumonia SARS-CoV2 Serious Adverse Event Serious Adverse Events severe acute respiratory syndrome Coronavirus Significant reduction significant reductions single-center study supported T-cell temperature therapy Tocilizumab Treatment vasopressor requirement vasopressor requirements vasopressor support
[DOI] 10.1093/cid/ciaa812 PMC 바로가기 [Article Type] Article

Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Randomized Controlled Trial

Published on 2020-12-112022-10-04
Journal: The New England Journal of Medicine [Category] Fulltext, MERS, 임상, 치료제,

Nebulised surfactant for the treatment of severe COVID-19 in adults (COV-Surf): A structured summary of a study protocol for a randomized controlled trial

성인의 중증 COVID-19 치료를 위한 분무형 계면활성제(COV-Surf): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Randomized Controlled Trial

Published on 2020-12-102022-09-10
Journal: Trials [Category] MERS, SARS, 비임상, 임상,

[키워드] 1080 24 hour 24 hours 48 hour 48 hours ACE2 ADEs administration Adverse adverse event adverse events AEs ALEA All participant All participants allergy alveolar angiotensin angiotensin converting enzyme angiotensin converting enzyme 2 anticipated attending physician bind Blinding block randomization Blood bovine breath buffer calcium cells cellular cholesterol Chronic kidney disease class clinical Clinical improvement clinical trial clinical trials Cohort Combination comparator Compliance Concentration conducted Consent contraindication contributing to Control control arm controls COVID-19 COVID-19 adult patient COVID-19 patients current cytokine Data collection Data monitoring committee death declined defined delivery described Device dialysis discretion dissemination dose drug Effect Efficacy EGFR element Eligible participants end point End-Expiratory Pressure Endotracheal intubation enrolled Enrollment enrolment epithelial Escalation EudraCT evaluate exclusion exclusion criteria expected fatty Fatty acid feasibility free fatty acid Frequency hospital hospitalised hypoxia impair include inclusion criteria index Inflammatory marker inflammatory markers Inflammatory response intensive care intensive care unit Intervention investigator Kidney disease lack liver liver failure Local lung lung lavage mechanical ventilation mechanical ventilator mechanically ventilated patient mechanically ventilated patients mixture Mortality nebulisation number objective Open-label opinion Ordinal Scale other treatment outcome oxidative stress Oxygenation PaO participant Patient PCR PEEP Phosphatidylcholine phosphatidylethanolamine phosphatidylglycerol phosphatidylinositol phospholipid PIP Placebo plasma Pneumothorax Positive end-expiratory pressure Prevent Primary outcome progression Protein protocol pulmonary compliance pulmonary hemorrhage pulmonary ventilation quantification randomisation randomised randomised controlled trial Randomized Randomized controlled trial reached receive recorded recruitment reduction Registered reported Respiratory failure SAEs Sample size SARS-CoV-2 viral load SARS-CoV-2 virus secondary outcome Secondary outcomes Serious Adverse Events severe COVID-19 severity sphingomyelin Stage Standard Standard of care status Study protocol subject supplementary material surface tension surfactant synthesis tension the WHO tissue damage total sample size tracheal tracheal aspirate Tracheal aspirates transfer Treatment Trial Trial Steering Committee turnover unique university University College London usual standard of care Ventilation Ventilation Index ventilatory support VFD vibrating mesh nebulizer Viral Viral load virus water website weight with COVID-19 worsening
[DOI] 10.1186/s13063-020-04944-5 PMC 바로가기 [Article Type] Randomized Controlled Trial

Efficacy and harms of remdesivir for the treatment of COVID-19: A systematic review and meta-analysis

코로나19 치료를 위한 렘데시비르의 효능과 유해성: 체계적인 검토 및 메타분석

Meta-Analysis

Published on 2020-12-102022-09-10
Journal: PLoS ONE [Category] SARS, 임상, 치료제,

[키워드] 95%CI all-cause mortality analyzed can not case sery clinical Clinical improvement COVID-19 decrease disease Effect Efficacy and safety Evidence heterogeneity high risk hospitalized COVID-19 hospitalized COVID-19 patients Intravenous remdesivir invasive ventilation inverse meta-analyses Meta-analysis nine no differences outcome performed Placebo Primary outcomes random effect Randomized controlled trial RCT RCTs regimen Remdesivir reported Result SAE SAEs searched Serious Adverse Event Serious Adverse Events severity Standard of care systematic review therapy time treating COVID-19 Treatment treatment of COVID-19
[DOI] 10.1371/journal.pone.0243705 PMC 바로가기 [Article Type] Meta-Analysis

Comparing outcomes of hospitalized patients with moderate and severe COVID-19 following treatment with hydroxychloroquine plus atazanavir/ritonavir

하이드록시클로로퀸 + 아타자나비르/리토나비르 치료 후 중등도 및 중증 COVID-19로 입원한 환자의 결과 비교

Comparative Study

Published on 2020-12-012022-09-11
Journal: Daru : journal of Faculty of Pharmacy, Tehran Univ [Category] 치료제,

[키워드] 28-day mortality Admission adverse events age Antiviral antiviral therapy Atazanavir atazanavir/ritonavir baseline Clinical outcome clinical outcomes Complication Course COVID-19 Definition discharge discharge rate discharged patient discharged patients disease Dyspnea Efficacy and safety evaluated exertional dyspnea Hair loss hospital Hospital admission hospital discharge Hospital stay Hospitalization hospitalized patient Hydroxychloroquine ICU incidence intensive care intensive care unit intubation investigated Length less male matter moderate Mortality National national treatment outcome outcomes oxygen Patient patients patients treated patients with COVID-19 patients with moderate peripheral oxygen saturation Pneumonia regimen Ritonavir Serious Adverse Event Serious Adverse Events severe COVID-19 severe disease severe group severity significantly higher significantly shorter SpO2 Support Symptom the disease the patient Treatment treatment of COVID-19 Treatment protocol use of hydroxychloroquine weakness WHO definition
[DOI] 10.1007/s40199-020-00369-2 PMC 바로가기 [Article Type] Comparative Study

Post-exposure prophylaxis with hydroxychloroquine for the prevention of COVID-19, a myth or a reality? The PEP-CQ Study

Research article

Published on 2020-12-012022-10-05
Journal: International journal of antimicrobial agents [Category] SARS, 임상,

[키워드] 95% CI adverse event assigned asymptomatic individual Contact Controlled clinical trial COVID-19 COVID-19 case COVID-19 patient Day Direct drug Follow-up group HCQ highest home quarantine household contact Hydroxychloroquine hygiene in vitro incidence of COVID-19 Inconclusive individuals International laboratory-confirmed NNT Occurrence offered Open-label over pandemic participant Participants Post-exposure prophylaxis Prevent prevention prevention of COVID-19 Prophylaxis randomised clinical trial required risk risk reduction SARS-CoV-2 SARS-COV-2 infection Serious Adverse Events significantly social distancing therapy Travel virucidal
[DOI] 10.1016/j.ijantimicag.2020.106224 [Article Type] Research article

Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial

COVID-19 환자의 인터페론 β-1a(IFNβ-1a)(INTERCOP): 무작위 대조 시험을 위한 연구 프로토콜

Study Protocol

Published on 2020-11-232022-08-13
Journal: Trials [Category] SARS, 임상,

[키워드] 7-point ordinal scale addition Administered ameliorated animal model animal models anti-viral activity anti-viral drug antibody biochemical marker biochemical markers blood cell blood cell counts changes in clinical benefit clinical benefits clinical severity score clinical status clinical trial Combination Computed tomography cornerstone coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patient COVID-19 patients COVID-19 treatment cytokine death dose Efficacy EudraCT Evidence evidence of Hospital stay Identifier IFNβ-1a IFNβ IFNβ-1a implication in vitro include indicated Inflammatory intensive care intensive care unit INTERCOP INTERCOP trial interferon interferon-stimulated genes International international units intervention arms mild-to-moderate disease moderate disease Mortality mRNA expression profile nasopharyngeal swabs Negative conversion Open-label Ordinal Scale organ dysfunction outcome oxygen oxygen- Patient Pneumonia positive swab Potential Primary outcome pulmonary computed tomography pulmonary computed tomography severity score radiological Randomized Randomized controlled trial rationale reduce reduced reduction regimens Safe SARS-CoV-2 SARS-COV-2 infection secondary Secondary outcomes Serious Adverse Events severity Standard of care Study protocol subcutaneously therapeutic therapy transfer Treatment Trial Trial registration Ventilator-free days Viral Viral load worsening
[DOI] 10.1186/s13063-020-04864-4 PMC 바로가기 [Article Type] Study Protocol

Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

코로나19 예방 백신: 개별 환자 데이터를 포함하는 네트워크 메타 분석을 통한 살아있는 체계적인 검토를 위한 프로토콜(The LIVING VACCINE Project)

Protocol

Published on 2020-11-202022-09-10
Journal: Systematic Reviews [Category] COVID-19, meta-analysis, SARS,

[키워드] active placebo acute respiratory syndrome acute respiratory syndrome coronavirus aggregate data meta-analyses all age groups all-cause mortality analyzed approach assessment assessments best cause CENTRAL certainty certainty of evidence Clinical research clinical trial registries clinical trial registry clinical trials confidence coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 database dendritic dendritic cell described development Diagnosis disease Effect events Evidence GRADE identify inactivated include individual patient data meta-analyses life Messenger RNA meta-analyses Mortality network Network meta-analysis non-serious adverse non-serious adverse events not limited observational studies observational study once a week outcome pandemic participant patient data Placebo prevalent Prevent Primary outcomes Protein Protein subunit protocol Quality of life randomized clinical trial randomized clinical trials Research respiratory risk of bia SARS-CoV-2 secondary Secondary outcomes Serious Adverse Events severe acute respiratory syndrome Coronavirus severe acute respiratory syndrome coronavirus 2 Spread standard care supplementary material systematic review Trial trial sequential analyses Vaccine vaccine for COVID-19 Vaccines Viral Viral vector
[DOI] 10.1186/s13643-020-01516-1 PMC 바로가기 [Article Type] Protocol

Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-10-282022-10-29
Journal: Trials [Category] Coronavirus, MERS, SARS,

[키워드] 1:1 24 hour Ability absence accompany activity Administered administration Admission adverse events Affect age alkaline phosphatase allergy ALT alternative hypothesis ambient Analysis ANC Anti-inflammatory anticipated antipyretics antivirals Arm ARMS assumed AST Baltimore baseline benefit blinded block block randomization Blood breastfeeding women Bronchoalveolar lavage calculated Care Cellulose center Chest chest X-ray childbearing potential clinical clinical condition Clinical course clinical impact Clinical improvement Clinical outcome clinical status clinical trial collected competing Compliance concealed Concentration Concomitant conditions conducted congestive heart failure Contraception Control control arm Conventional Corticosteroids COVID-19 COVID-19 disease COVID-19 infection COVID-19 pandemic criteria criterion Critical CT scan current Day Declaration of Helsinki decrease defined detect direct bilirubin disease disorder dissemination dose double-blind drug Drug administration drug-drug interaction drugs Duration ECMO Efficacy Efficacy and safety element eligible endosomal pH Enrollment ethnic group evaluate Evidence exclusion expected exploratory endpoint extracorporeal membrane oxygenation Face mask FDA Fisher Good group handling harmonization hematologic histocompatibility complex Hospitalization Hospitalized hospitalized patient Hydroxychloroquine Hypothesis ICU IL-6 levels Imatinib immunomodulatory immunomodulatory drugs IND information Informed consent inhibitory activity intensive care intensive care unit intention to treat interfere International Conference invasive Invasive mechanical ventilation investigational agent investigator ITT Laboratory Last limit limitation liver Local lysosomal sequestration magnitude matching placebo mechanical ventilation men and women MHC mononuclear cell Mortality nasal nasopharyngeal Nasopharyngeal swab neutrophil count New new oxygen use non-invasive ventilation non-rebreather mask not blinded null hypothesis number objective off-label off-label use Oropharyngeal outcome outcomes oxygen Oxygenation P450 packaged PaO participant Participants Patient patients patients with ARDS patients with COVID-19 PBMCs performed Pharmacist Pharmacy phase 3 study Placebo placebo-controlled Pneumonia positive COVID-19 Practice primary analysis primary endpoint principal progression proportion protocol Psychiatric Radiographic random number generator randomised controlled trial randomization Randomized Randomized controlled trial receive receiving recruitment Regulatory renal dysfunction renal replacement therapy replication of SARS-CoV-2 required requiring supplemental oxygen Respiratory illness respiratory tract risk RT-PCR Safety Sample size sarilumab SARS-CoV SARS-CoV-2 secondary endpoint Seizure Serious Adverse Events service severe disease severity significance level Site Society stability Standard of care status stratified study drug study enrollment study outcomes Study protocol subject submitted supplemental oxygen Support Suspension symptomatic Tablet temperature Test the patient the primary endpoint time TKI TKI-induced attenuation of vascular leak TKI-induced prevention and treatment lung inflammation Tocilizumab transcriptomics Treatment treatment allocation treatment arm treatments for COVID-19 Trial two-sided tyrosine kinase inhibitor uncontrolled university unstable angina vasopressors ventilator ventilator free days viral ABL-1 signalling website with COVID-19
[DOI] 10.1186/s13063-020-04819-9 PMC 바로가기 [Article Type] Letter