Serious Adverse Events – Page 6 – Communicable Diseases Research

Treatment of COVID-19-associated ARDS with mesenchymal stromal cells: a multicenter randomized double-blind trial

Randomized Controlled Trial

Published on 2022-02-212022-10-04
Journal: Critical Care [Category] COVID19(2023년), MERS, SARS, 임상,

Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study

브라질에서 코로나 박 코비드 -19 백신의 이전 수용자 (RHH-001)의 이전 수용자에서 이종과 동종 코비드 -19 부스터 백신 접종

Clinical Trial

Published on 2022-02-052022-08-13
Journal: Lancet (London, England) [Category] COVID19(2023년), MERS, SARS, 변종, 유전자 메커니즘, 임상, 진단, 치료기술,

[키워드] 95% CI Ad26 Ad26.COV2-S Ad26.COV2-S vaccine Administered administration adverse events age All participant All participants anti-Spike IgG anti-spike IgG antibodies Anti-spike IgG antibody anti-spike IgG response Anti-spike IgG responses Antibody concentrations assigned AstraZeneca AZD1222 B.1.1.529 B.1.617.2 baseline binding blind BNT162b2 boost booster booster dose booster vaccination Booster vaccine Brazil ChAdOx1 ChAdOx1 nCoV-19 ChAdOx1 nCoV-19 vaccine Concentration CoronaVac COVID-19 COVID-19 vaccine detectable discharged home dose eligible ENhance except for finding FIVE for inclusion four groups funding geometric geometric mean geometric mean ratio geometric mean ratios group Heterologous homologous homologous booster responses IgG antibody IgG responses immune response immune responses immunogenicity IMPROVE inactivated Infection inferiority janssen Live virus neutralising antibodies Local local and systemic reactogenicity profiles Ministry of Health mRNA vaccine Neutralising Antibodies neutralising antibody neutralising antibody titre neutralising antibody titres non-inferiority non-inferiority margin Older Older adults Omicron variant Omicron variants outcome participant Pfizer Pfizer–BioNTech phase 4 primary analysis Primary outcome profiles pseudovirus neutralising antibodies randomisation randomised Randomly reached recipient recombinant adenoviral vectored vaccine recombinant adenoviral-vectored ChAdOx1 nCoV-19 vaccine regimen Registered RHH-001 robust secondary Secondary outcomes Serious Adverse Events Seropositivity significant increase Sinovac stratified systemic reactogenicity the vaccine Vaccine vectored vaccine virus neutralising antibody whole-virion SARS-CoV-2 vaccine
[DOI] 10.1016/S0140-6736(22)00094-0 PMC 바로가기 [Article Type] Clinical Trial

Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial

기준 항체 및 항원 수준에 따른 COVID-19 입원 환자의 중화 단일클론항체에 대한 반응: 무작위 대조 시험

Randomized Controlled Trial

Published on 2022-02-012022-09-11
Journal: Annals of internal medicine [Category] COVID19(2023년), MERS, SARS, 바이오마커, 임상, 진단, 치료기술, 치료법, 치료제,

[키워드] allergy Analysis analyzed Anti-spike antibodies antibody Antigen bamlanivimab baseline benefit clinical trial collected Combination Controlled COVID-19 death defined detectable discharge elevated end-organ evaluate evidenced favor futility Government greater hazard hazard ratios hospitalized patient hospitalized patients Hypothesis immune IMPROVE independent Infectious diseases Interaction Level limited sample size median median time monoclonal antibody mounted Multicenter trial NAb NAbs nasal neutralizing antibody not differ operation Organ failure outcome participant Patient patients with COVID-19 Placebo placebo group placebo-controlled placebo-controlled trial plasma Randomized receiving Remdesivir required response SARS-CoV-2 nucleocapsid Serious Adverse Events serious infections serostatus small sample size specimen speed subgroup subgroup analysis sustained the median therapy Trial Viral Viral RNA with COVID-19
[DOI] 10.7326/M21-3507 PMC 바로가기 [Article Type] Randomized Controlled Trial

Intravenous immunoglobulins in patients with COVID-19-associated moderate-to-severe acute respiratory distress syndrome (ICAR): multicentre, double-blind, placebo-controlled, phase 3 trial

COVID-19 관련 중등도에서 중증 급성 호흡 곤란 증후군(ICAR) 환자의 정맥 면역글로불린: 다기관, 이중 맹검, 위약 대조, 3상 시험

Clinical Trial

Published on 2022-02-012022-09-12
Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), MERS, SARS, 임상, 진단,

[키워드] 1:1 acute respiratory distress Administered administration adverse event adverse events ARDS Clinique complication of COVID-19 COVID-19 disease stage distress double-blind eligible event for inclusion France Frequency high mortality Immunoglobulin IMPROVE improve clinical outcome Inclusion intention-to-treat analysis intention-to-treat principle Intravenous immunoglobulin Invasive mechanical ventilation Lung injury morbidity multicentre no statistical difference not significant outcome Patient patients patients with COVID-19 PCR phase 3 trial Placebo placebo-controlled placebo-controlled trial Primary outcome Randomly randomly assigned patient receive receiving reducing Registered risk Serious Adverse Events Sodium chloride stratified syndrome the median the placebo group Treatment Trial trials Volume was done web-based system women
[DOI] 10.1016/S2213-2600(21)00440-9 PMC 바로가기 [Article Type] Clinical Trial

Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial

COVID-19(DisCoVeRy)로 입원한 환자의 치료를 위한 렘데시비르 + 표준 치료 대 표준 치료 단독: 3상, 무작위, 대조, 공개 시험

Clinical Trial

Published on 2022-02-012022-09-11
Journal: The Lancet. Infectious Diseases [Category] Fulltext, MERS, 임상, 치료법, 치료제,

[키워드] Abstract activities activity acute respiratory distress acute respiratory distress syndrome adaptive Administered Adult patient Adult patients Analysis antiviral efficacy assigned Bacterial infection Belgium block Breastfeeding Chronic kidney disease clinical clinical benefit Clinical efficacy clinical evidence Clinical research clinical status Combination Commission computer-generated conducted control group Controlled trial COVID-19 criteria death development discharged distribution elevated elevated liver enzymes eligible enrolled Europe European evaluate evidence of exclusion criteria extracorporeal membrane oxygenation followed by France French group Health care hepatorenal syndrome high flow oxygen devices hospital hospitalised Hydroxychloroquine Inclusion indication Innovation intention-to-treat population interferon interferon beta Interferon beta-1a intravenous intravenous infusion Invasive mechanical ventilation investigators Kidney disease laboratory-confirmed SARS-CoV-2 infection limitation liver enzymes Lopinavir Lopinavir-ritonavir Luxembourg material Ministry of Health modified intention-to-treat multicentre no significant difference non-invasive ventilation not significant Occurrence Odds ratio once daily one health Open-label Ordinal Scale oxygen oxygen supplementation oxygen support participant Patient Phase 3 Pneumonia Portugal Pregnancy Primary outcome random assignment randomisation randomised Randomly receive Regional Registered Remdesivir required requiring supplemental oxygen respiratory distress ribavirin Ritonavir Safety SARS-CoV-2 SARS-COV-2 infection Secondary outcomes Serious Adverse Event Serious Adverse Events seven-point ordinal scale Severity of disease Sponsor Standard of care stratified supplemental oxygen Support symptomatic syndrome the WHO translation Treatment treatment group treatment groups Trial Tumor union ventilator were excluded WHO ordinal scale with COVID-19
[DOI] 10.1016/S1473-3099(21)00485-0 PMC 바로가기 [Article Type] Clinical Trial

Association between tocilizumab treatment and clinical outcomes of COVID-19 patients: a systematic review and meta-analysis

COVID-19 환자의 토 실리 주맙 치료와 임상 결과 사이의 연관성 : 체계적인 검토 및 메타 분석

Meta-Analysis

Published on 2022-01-312022-09-01
Journal: Aging (Albany NY) [Category] 임상, 진단,

Pharmacokinetics of high-titer anti–SARS-CoV-2 human convalescent plasma in high-risk children

고위험 소아에서 고역가 항-SARS-CoV-2 인간 회복기 혈장의 약동학

Clinical Trial

Published on 2022-01-252022-09-12
Journal: JCI Insight [Category] 임상, 진단,

[키워드] age Analysis Anti-spike anti-Spike IgG antibody antibody kinetics antibody production Antibody titer Antibody titers appear characterized children convalescent plasma coronavirus COVID-19 declined develop disease Donor ELISA assays enrolled epitope Euroimmun evaluated expected exposure to funding IgG immunoglobulins Infectious disease Kinetics Kinetics of antibodies median age Mild Mild disease neutralization capacity neutralization titer neutralizing capacity NIH passive transfer performed pharmacokinetic pharmacokinetics plasma PROTECT receive recipient Research Safe SARS-CoV-2 Serious Adverse Event Serious Adverse Events severe disease Spike protein symptom onset transferred transfused transfusion Trial registration underlying condition underlying conditions unlikely virus neutralization assays weight while
[DOI] 10.1172/jci.insight.151518 PMC 바로가기 [Article Type] Clinical Trial

Vaccines to prevent COVID-19: A living systematic review with Trial Sequential Analysis and network meta-analysis of randomized clinical trials

COVID-19를 예방하기위한 백신 : 무작위 임상 시험의 시험 순차 분석 및 네트워크 메타 분석을 통한 살아있는 체계적인 검토

Meta-Analysis

Published on 2022-01-212022-09-10
Journal: PLoS ONE [Category] meta-analysis, 임상,

[키워드] 95% CI 95% confidence interval all-cause mortality analyses Analysis CENTRAL certainty certainty of evidence clinical trials comparable conducted confidence interval COVID-19 COVID-19 vaccine COVID-19 vaccines database databases decreased mortality effective Effective vaccines Effectiveness Efficacy events Evidence evidence of Follow-up GRADE inactivated Inactivated vaccine Inactivated Vaccines inception increased the risk independent meta-analyses Meta-analysis moderate mRNA mRNA vaccine mRNA vaccines Network meta-analysis non-serious adverse non-serious adverse events participant Prevent prevented Primary outcome protein subunit vaccine Protein subunit vaccines randomized clinical trial randomized clinical trials randomizing reducing mortality risk risk ratio risks of bias safety profile screened searched Serious Adverse Events subunit vaccines suggested systematic review the vaccine the vaccines Trial trial sequential analyses trials TSA Vaccine vaccine efficacy Vaccines Viral Viral vector vaccine Viral vector vaccines
[DOI] 10.1371/journal.pone.0260733 PMC 바로가기 [Article Type] Meta-Analysis

The incidence of COVID-19 infection following emergency use authorization of BBIBP-CORV inactivated vaccine in frontline workers in the United Arab Emirates

응급 사용 후 Covid-19 감염의 발생률은 아랍 에미리트의 최전선 근로자에서 BBIBP-CORV 불활성 백신의 승인

Article

Published on 2022-01-112022-09-10
Journal: Scientific Reports [Category] SARS, 임상, 진단, 치료기술,

Safety and Immunogenicity of the Third Booster Dose with Inactivated, Viral Vector, and mRNA COVID-19 Vaccines in Fully Immunized Healthy Adults with Inactivated Vaccine

Article

Published on 2022-01-062022-10-28
Journal: Vaccines [Category] COVID-19,

[키워드] acute respiratory syndrome addition administration adverse events anti-RBD AZD1222 binding domain BNT162b2 booster booster dose booster response booster vaccination clinical trial CoronaVac coronavirus coronavirus disease COVID-19 COVID-19 vaccine dose doses healthcare healthy IgA IgG immunogenicity Inactivated vaccine indicated individual Infection mRNA mRNA vaccine neutralization activity outbreak pandemic Patient platform proportion RBD receiving Safe Safety SARS-CoV-2 secreting Serious Adverse Events serum severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) significant increase Spread T-cell Response third dose vaccination Vaccines variant vector Viral vector Viral vector vaccine wild-type
[DOI] 10.3390/vaccines10010086 PMC 바로가기 [Article Type] Article