Serious Adverse Events – Page 11 – Communicable Diseases Research

Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial

Clinical Trial

Published on 2021-09-012022-10-05
Journal: The lancet. Diabetes & endocrinology [Category] 임상,

Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting

BNT162b2 mRNA 코로나19 백신의 전국적 안전성

Original Article

Published on 2021-08-252022-11-01
Journal: The New England Journal of Medicine [Category] COVID-19, Fulltext, MERS, 대상포진, 두창, 수두,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome adverse event analyses Analysis Appendicitis arrhythmia BNT162b2 mRNA BNT162b2 mRNA vaccine BNT162b2 vaccine Care clinical variables collaboration control group coronavirus deep-vein thrombosis Diagnosis elevated evaluate event examined family Francesca Harvard Medical School Health hemorrhage herpes zoster increased risk Infection Kaplan–Meier estimator limitations Messenger RNA Myocardial infarction myocarditis performed Result risk risk ratio Safety safety profile SARS-CoV-2 SARS-COV-2 infection Serious Adverse Event Serious Adverse Events setting Sociodemographic subject Trial uninfected used data vaccination Vaccine
[DOI] 10.1056/NEJMoa2110475 PMC 바로가기 [Article Type] Original Article

Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial

남아프리카에 HIV가 있거나없는 사람들의 SARS-COV-2에 대한 Chadox1 NCOV-19 (AZD1222) 백신의 안전성 및 면역 원성 : 무작위, 이중 맹검, 위약 대조, Phase 1B/2A 시험의 중간 분석

Clinical Trial

Published on 2021-08-172022-08-13
Journal: The Lancet. HIV [Category] MERS, SARS, 변종, 임상, 진단,

[키워드] 1:1 1B/2A trial 95% CI adverse event adverse events African Alanine alanine aminotranferase allocation concealment Antibody Response Antibody Units Antiretroviral therapy Asp614Gly wild-type AZD1222 B.1.351 baseline Beta Beta variant binding antibodies binding antibody unit booster booster response both groups ChAdOx1 ChAdOx1 nCov 19 ChAdOx1 nCoV-19 clinical COV005 criteria cross-reactive binding antibodies cross-reactive binding antibody cross-reactivity D614G demonstrated died domain dose double-blind elevated eligibility criteria enrolled enrolment Fever finding FIVE foundation full-length funding geometric mean geometric mean concentration GMC high responder high responders High-level binding antibody HIV HIV-negative hospital IgG responses immunogenicity in both groups increased risk individual individuals Innovation interim analysis Intervention less Medical Research Council Melinda Gate Melinda Gates n=36 nCoV neutralisation Neutralising activity outcome Pan participant Participants people with HIV person with HIV Placebo placebo-controlled plasma Primary immunogenicity analyses Primary immunogenicity analysis prime-boost regimen priming priming dose randomised Randomly reactogenicity receive Receptor-binding domain Registered registry responses responses against retained rising Safety SARS-CoV-2 SARS-CoV-2 antigen SARS-CoV-2 antigens Serious Adverse Events seronegative seropositive serum IgG Seven severe COVID-19 South South Africa titre Trial unlikely Vaccine vaccine dose Viral Viral load wild-type wild-type Wuhan-1 Asp614Gly with HIV
[DOI] 10.1016/S2352-3018(21)00157-0 PMC 바로가기 [Article Type] Clinical Trial

Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study

COVID-19 관련 중등도 폐렴에 대한 돼지 당-인간화 다클론성 항-SARS-CoV-2 항체인 XAV-19의 약동학 및 안전성: 무작위 배정, 이중 맹검, 위약 대조, IIa상 연구

Clinical Trial

Published on 2021-08-172022-09-11
Journal: Antimicrobial Agents and Chemotherapy [Category] SARS, 비임상, 임상,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 administration adverse event adverse events anti-SARS-CoV-2 antibody antibody baseline characteristics body weight breath C max Characteristics Concentration concentrations coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 demonstrated drug during treatment enrolled evaluate group hypersensitivity IIa in vitro infusion inhibitory concentration intravenous dose maximum serum concentration median moderate Neutralizing activity optimal dose Patient Perfusion pharmacokinetics phase phase IIa Placebo Pneumonia polyclonal polyclonal antibody polyclonal glyco-humanized anti-SARS-CoV-2 antibody. Predictive Randomized reaction receive Registered reported Safety SARS-CoV-2 Serious Adverse Event Serious Adverse Events serum serum concentrations severe acute respiratory syndrome Coronavirus study drug Tolerability Treatment Trial XAV-19
[DOI] 10.1128/AAC.01237-21 PMC 바로가기 [Article Type] Clinical Trial

Systemic corticosteroids for the treatment of COVID-19

COVID-19 치료를 위한 전신 코르티코스테로이드

Review

Published on 2021-08-162022-09-11
Journal: The Cochrane database of systematic reviews [Category] SARS, 임상,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome adjust adverse event adverse events age all-cause mortality analysed Analysis applicability approach arising Arm Asymptomatic asymptomatic infection baseline benefit caution CENTRAL certainty certainty of evidence change citation Cochrane COVID-19 Study Register Combination comparison Comparisons composite endpoint control group coronavirus disease coronavirus diseases Corticosteroid Corticosteroids COVID-19 Data collection death Descriptive statistics Dexamethasone Diagnosis direction disease disease severity dosage dosages dose doses doses of corticosteroids effective Effects eligible endpoints estimate Ethnicity evaluated Evidence excluded Factor FIVE Follow-up Gender heterogeneous high risk hospital-acquired infections hospitalised hyper-inflammation identify include index individual Inhaled inhaled corticosteroids inherent invasive Invasive mechanical ventilation invasive ventilation life limitation long-COVID majority median medRxiv methodology Methylprednisolone Middle East Middle East respiratory syndrome Mild Mild disease Mortality MOST New nine non-hospitalised occurred Other outcomes outcome outcomes Outpatient outpatients participant Participants Patient people with COVID-19 Placebo Population Quality Quality of life randomisation randomised randomised controlled trial Randomised controlled trials RCT RCTs reduce reduction in regimen reported Respiratory Support risk risk difference risk of bia risk ratio Safe Science Citation Index searched Selection Serious Adverse Events Severe acute respiratory syndrome standard care subgroup subgroups subsequent suspected diagnosis symptomatic symptomatic COVID-19 syndrome systematic review systemic systemic corticosteroid systemic corticosteroids the WHO therapy topical treat Treatment Trial Ventilation ventilator-free day Ventilator-free days Web of Science WHO ICTRP
[DOI] 10.1002/14651858.CD014963 PMC 바로가기 [Article Type] Review

Efficacy and Safety of Cannabidiol Plus Standard Care vs Standard Care Alone for the Treatment of Emotional Exhaustion and Burnout Among Frontline Health Care Workers During the COVID-19 Pandemic A Randomized Clinical Trial

Research

Published on 2021-08-132022-10-29
Journal: JAMA Network Open [Category] COVID-19, MERS, SARS,

[키워드] 1:1 95% CI adverse effects age benefit block randomization Brazil Burnout cannabidiol Care clinical COVID-19 COVID-19 pandemic Critical double-blind Effect effective Efficacy efficacy analysis elevated Elevation eligibility Emotional exhaustion enrolled Exhaustion Final finding full recovery Future Health Importance incidence Intervention inventory involved liver enzyme mean difference measure Mild Nurses objective Open-label participant Participants Patient patients with COVID-19 per day physical Physicians placebo-controlled clinical trial Point Primary outcome professional professionals Randomized randomized clinical trial receive receiving recruited reduced reducing reduction Registration Relevance reported researcher Result Safety School Serious Adverse Events service setting significantly Standard standard care survey Symptom Symptoms therapy Treatment treatment arm treatment group university were assessed women worker
[DOI] 10.1001/jamanetworkopen.2021.20603 PMC 바로가기 [Article Type] Research

Remdesivir for the treatment of COVID-19

코로나19 치료제 렘데시비르

Article

Published on 2021-08-052022-09-11
Journal: The Cochrane database of systematic reviews [Category] SARS, 임상, 치료제,

[키워드] 95% CI 95% confidence interval adverse event adverse events age all-cause mortality antiviral medicine approach authorisation baseline CENTRAL certainty certainty of evidence chance citation clinical Clinical improvement Clinical outcome clinical outcomes clinical status Cochrane COVID-19 Study Register comparable conducted contribute Controlled controlled trials coronavirus disease coronavirus diseases COVID-19 COVID-19 patient COVID-19 patients COVID-19 research Data collection decrease defined diagnosed died disease severity Effect Efficacy and safety Emergency use Ethnicity evaluated Evidence excluded FIVE Future Gender high risk High-flow oxygen hospitalised hospitalised patient Hospitalised patients identify increase index individual information inhibit initial Invasive mechanical ventilation lack liberation life low-flow oxygen maintain Mask mechanical ventilation media medRxiv methodology Missing data missing value missing values Mortality MOST nasal prong nasal prongs need for oxygen no difference no effect Non-invasive non-invasive mechanical ventilation non-invasive ventilation observation outcome outcomes oxygen participant Participants Patient Placebo potential benefit potential benefits Quality of life randomised randomised controlled trial Randomised controlled trials RCT RCTs receive recruit registry Remdesivir reported required Respiratory Support risk risk difference risk of bia risk ratio RoB 2 SARS-CoV-2 SARS-COV-2 infection Science Citation Index searched Selection Serious Adverse Event Serious Adverse Events severity Source standard care subgroup subgroups supplemental oxygen systematic review Treatment viral replication Web of Science WHO WHO International Clinical Trials Registry Platform worsening
[DOI] 10.1002/14651858.CD014962 PMC 바로가기 [Article Type] Article

Coronavirus disease 2019 vaccines: landscape of global studies and potential risks

코로나바이러스 질병 2019 백신: 글로벌 연구 및 잠재적 위험의 전망

Review

Published on 2021-08-022022-09-11
Journal: Chinese medical journal [Category] SARS, 변종,

Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial

Covid-19 (Colcorona)를 가진 지역 사회 치료 환자를위한 콜히친 : 3 단계, 무작위, 이중 맹검, 적응 형, 위약 대조, 다중 센터 시험

Clinical Trial

Published on 2021-08-012022-08-13
Journal: The Lancet. Respiratory Medicine [Category] MERS, SARS, 임상,

[키워드] 1:1 absence adaptive adverse event allocation sequence Analysis anti-inflammatory agent assigned automated automated interactive web-response system benefit block size block sizes blocking schema Brazil Canada clinical criteria Colchicine colchicine group COLCORONA trial community-treated patient community-treated patients complications Composite computer-generated coronary disease COVID-19 COVID-19 complication COVID-19 complications COVID-19-related clinical event COVID-19-related clinical events COVID-19-related death death diagnosed diagnostic test diarrhoea double-blind double-blinded eligible enrolled excessive inflammation family finding foundation funding Gout Government Greece heart high-risk characteristic hospital Hospital admission intention-to-treat principle interactive web-response system IQR mandatory diagnostic test masked randomisation matching placebo median age Medicine Melinda Gate Melinda Gates Montreal Heart Institute multicentre occurred Odds ratio oral anti-inflammatory medication orally administered colchicine orally administered therapies orally administered therapy Participants Patient patients PCR testing PCR-confirmed PCR-confirmed COVID-19 PCR-positive community-treated patient PCR-positive community-treated patients per day Pericarditis Phase 3 Placebo placebo group placebo-controlled Pneumonia Prevent primary efficacy endpoint primary endpoint randomisation list randomised Randomly receive Registered Replication reported risk Safe School Serious Adverse Events Sophie South Africa Spain statistically significant the placebo group the primary endpoint treated Trial trial enrolment unmasked biostatistician USA Vital vital status was done with COVID-19
[DOI] 10.1016/S2213-2600(21)00222-8 PMC 바로가기 [Article Type] Clinical Trial

Low immunogenicity to SARS-CoV-2 vaccination among liver transplant recipients

간 이식 환자 중 SARS-CoV-2 백신 접종에 대한 낮은 면역원성

Article

Published on 2021-08-012022-09-11
Journal: Journal of hepatology [Category] MERS, SARS, 진단, 치료법,

[키워드] age All participant All participants antibody Antibody Response Antibody titer approved average BNT162b2 center Clinical data Control controls COVID-19 COVID-19 infection dose Efficacy elicited enrolled Factor female filtration rate glomerular filtration rate healthy healthy controls healthy volunteer healthy volunteers High dose IgG IgG antibodies Immunity immunogenicity Immunological response immunosuppressive medications include less levels of antibody liver liver transplant Liver transplantation medical records mRNA vaccine mRNA-based vaccine mycophenolate mycophenolate mofetil N-protein nucleocapsid Older age Patient Pfizer Pfizer-BioNTech Pfizer-BioNTech BNT162b2 positive positive serology Prevent receiving recipient recipients regimen renal function reported risk S-protein SARS-CoV-2 SARS-CoV-2 IgG SARS-CoV-2 IgG antibodies SARS-CoV-2 IgG antibody SARS-CoV-2 vaccination SARS-CoV-2 vaccine Serious Adverse Event Serious Adverse Events serological serology Side effect significantly lower Special Population spike-protein steroid Steroids tested the patient Treatment trials vaccination Vaccine vaccine immunogenicity virus was collected
[DOI] 10.1016/j.jhep.2021.04.020 PMC 바로가기 [Article Type] Article