Serious Adverse Events – Page 17 – Communicable Diseases Research

Interventions for treatment of COVID-19: A living systematic review with meta-analyses and trial sequential analyses (The LIVING Project)

COVID-19 치료를 위한 중재: 메타 분석 및 시험 순차 분석을 통한 살아있는 체계적인 검토(The LIVING Project)

Research Article

Published on 2020-09-172022-08-13
Journal: PLoS Medicine [Category] Biochemistry, COVID-19, SARS,

Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials

Letter

Published on 2020-08-242022-10-29
Journal: Trials [Category] Coronavirus, MERS,

[키워드] administration Analysis ARMS asked assessment Characteristics Chinese clinical trial Comparator group comparison Corticosteroid COVID-19 Critically ill patient defined Dexamethasone disease severity dissemination dose Effect element eligible EudraCT Evidence greater group heterogeneity High dose Hydrocortisone information Interaction Intervention intervention effect intervention group investigator ISRCTN less low dose meta-analyses Meta-analysis meta-regression Methylprednisolone Mortality Network meta-analysis objective Odds ratio Open-label outcome p-values participant Patient per day Placebo placebo-controlled primary analysis Prospective protocol provided quantified random-effect randomised controlled trial randomization Randomized Randomized controlled trials randomized trial Research Risk of bias RoB 2 secondary Serious Adverse Events Standard of care steroid Study protocol subgroup subgroups systematic review the WHO therapeutic dose therapy Treatment Trial trials usual care website WHO
[DOI] 10.1186/s13063-020-04641-3 PMC 바로가기 [Article Type] Letter

Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial

중증 또는 치명적인 COVID-19 폐렴의 치료를 위한 Auxora 대 표준 치료: 무작위 대조 시험의 결과

Research

Published on 2020-08-142022-08-13
Journal: Critical Care [Category] MERS, 임상,

[키워드] 95% CI Abstract Administered adverse event Auxora baseline blinded calcium Calcium release-activated calcium Calcium release-activated calcium channel inhibitors channel inhibitor conducted COVID-19 COVID-19 pneumonia CRAC CRAC channel inhibitor CRAC channel inhibitors Critical cytokine demonstrated died dose Efficacy Enrollment FDA Fewer patient Fewer patients Guidance intravenously Invasive mechanical ventilation mechanical ventilation median time nine novel Open-label open-label study design Ordinal Scale outcome PaO Patient patient population patients with COVID-19 placebo-controlled study Pneumonia Proinflammatory cytokine Proinflammatory response proportion Pulmonary endothelium randomization Randomized Randomized controlled trial rate ratio receive receiving Regulatory respiratory respiratory complication Respiratory complications Result resulting risk safety profile Serious Adverse Event Serious Adverse Events Severe COVID-19 pneumonia significantly Standard of care study enrollment the median Time to recovery Tolerability transition Treatment Trial registration Two patient two patients
[DOI] 10.1186/s13054-020-03220-x PMC 바로가기 [Article Type] Research

A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-07-132022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 24 hour 48 hour Activation acute lung injury acute pneumonia acute respiratory distress syndrome Administered Adult age all-cause mortality Amendment antibodies antibody Antibody test anticipated antiviral therapy approval ARDS assessment assigned baseline Biomarker Blood cardiac disease Care change class Clinical improvement clinical study clinical trial complement Complement inhibitor component Computed tomography concealed Concentration conducted Confirmed Controlled coronary syndrome COVID-19 criteria current Day diagnosis of SARS-CoV-2 dialysis discharge dissemination dose Duration Efficacy element eligibility Endotracheal intubation EU Clinical Trial EudraCT evaluate the effect expected failure female patient Final fraction France Germany greater half-live hospital Hospitalization humanized Hypercoagulable state Immunoglobulin Infection Inflammatory inhibitor initiated intensive care Intubated intubation invasive Invasive mechanical ventilation investigator IVIG Japan Lung injury mechanical ventilation medication monoclonal multicenter Neisseria meningitidis Non-invasive number objective Open-label original outcome oxygen participant Patient patients randomized patients with COVID-19 Period peripheral capillary phase Placebo Pneumonia polymerase chain positive airway pressure presenting progression protocol randomised randomised controlled trial randomization randomization list Randomized randomized controlled study Randomly Ravulizumab receive recruitment registry Remdesivir renal respiratory respiratory distress Respiratory distress syndrome routine clinical care Safety screened Screening secondary Serious Adverse Events serum severe acute respiratory distress syndrome coronavirus 2 Severe acute respiratory syndrome severe COVID-19 severe pneumonia SOFA Spain SpO2 Sponsor stratified Study protocol supportive care survival The United States therapy time Treatment treatment-emergent adverse event Ultomiris United Kingdom ventricular Viral website with COVID-19 X-ray
[DOI] 10.1186/s13063-020-04548-z PMC 바로가기 [Article Type] Letter

Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study

경증/일반 COVID-19 감염에서 클로로퀸 대 로피나비르/리토나비르의 효능: 전향적, 공개 표지, 다기관, 무작위 대조 임상 연구

Study Protocol

Published on 2020-07-082022-08-13
Journal: Trials [Category] SARS, 임상,

[키워드] adage calculated caused Chain Reaction China Chinese Chloroquine Chloroquine phosphate clinical clinical recovery clinical study Comparisons completion control group COVID-19 COVID-19 infection drugs effective antiviral treatment Efficacy and safety eligible experiment fluorescent Follow-up follow-up period help hospitals IMPROVE include Infection Lopinavir Lopinavir/ritonavir multicenter negativity normal temperature Open-label outbreak participant Patient patients with COVID-19 performed phosphate plan polymerase chain polymerase chain reaction Primary outcome Randomized Randomized controlled clinical study Randomly Recovery time registry reverse transcription Ritonavir RT-PCR Safe SARS-CoV-2 secondary outcome Secondary outcomes Serious Adverse Event Serious Adverse Events statistical significance level temperature tested therapeutic potential therapy throat-swab treat Treatment treatment period Trial two-sided test two-sided tests with COVID-19
[DOI] 10.1186/s13063-020-04478-w PMC 바로가기 [Article Type] Study Protocol

Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial

비경구 3가 P2-VP8 소단위 로타바이러스 백신의 안전성 및 면역원성: 다중 부위, 무작위, 이중 맹검, 위약 대조 시험

Article

Published on 2020-07-012022-09-06
Journal: The Lancet. Infectious Diseases [Category] Communicable Disease,

[키워드] adjusted Adults adverse event adverse events African age All participants analysed Antigen assigned baseline block block size block sizes blocks blood sample Blood samples Comparisons death Deltoid muscle dose dose-escalation double-blind Efficacy elicited eligible enrolment evaluate febrile febrile convulsion Final finding FIVE foundation funding geometric mean geometric mean titre gestation GRADE group groups HIV infection IgA IgG IgG seroresponse IgG seroresponses immunogenic immunogenicity immunogenicity endpoint Infant Infants injection Injections Intramuscular injection Laboratory Local Melinda Gate Melinda Gates Meningitis multisite neutralising antibody neutralising antibody response Neutralising antibody responses neutralising antibody seroresponse neutralising antibody seroresponses no significant difference no significant differences occurred parent parents participant Participants Placebo placebo group placebo recipient placebo recipients placebo-controlled placebo-controlled trial pneumococcal pneumococcal meningitis protocol randomisation randomised Randomly receive recipient Registered Research respiratory Respiratory tract infections response responses against rotavirus vaccination rotavirus vaccine Safety safety endpoint Serious Adverse Event Serious Adverse Events serum significantly higher South South Africa Strains subunit Support systemic adverse events systemic reaction systemic reactions the placebo group the vaccine timepoints Treatment Trial trivalent USA Vaccine was done were assessed
[DOI] 10.1016/S1473-3099(20)30001-3 PMC 바로가기 [Article Type] Article

Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial

후보 중동 호흡기 증후군 코로나바이러스 바이러스 매개 백신의 안전성 및 면역원성: 용량 증량, 공개, 비무작위, 비통제, 1상 시험

Article

Published on 2020-07-012022-08-13
Journal: The Lancet. Infectious Diseases [Category] 임상,

[키워드] absence adverse event AID All participant All participants antibody Antigen Arabian Peninsula assigned baseline cellular cellular and humoral immunogenicity cellular response ChAdOx1 ChAdOx1 MERS clinical clinical development clinical trial coronavirus Department described dose dose-escalation doses effective elicit ELISA enzyme enzyme-linked immunospot expressing finding FIVE Follow-up follow-up period full-length full-length spike surface glycoprotein funding healthy hepatitis B hepatitis B surface antigen hepatitis C hepatitis C antibodies hepatitis C antibody High-dose high-dose group HIV antibodies humans humoral humoral immunogenicity IgG immunogenicity ImmunoSpot Infection interferon interferon-γ-linked enzyme-linked immunospot intermediate-dose group Intervention Intramuscular injection low-dose Medicine MERS MERS-CoV MERS-CoV spike antigen Middle East Middle East respiratory syndrome Coronavirus Mild mild in severity moderate neutralisation neutralisation assay Neutralising Antibodies nine Occurrence Open-label Oxford participant Phase 1 phase 1 trial pre-vaccination test pre-vaccination tests pregnancy test progression proportion Pseudotyped virus public health Registered Relative risk reported resolved respiratory respiratory syndrome coronavirus response risk Safe Safety Saudi Arabia Serious Adverse Event Serious Adverse Events severe adverse event significant increase significantly higher simian adenovirus-vectored vaccine single dose Support surface antigen Surface glycoprotein T-cell tested Tolerability trials tropical medicine urinary pregnancy test vaccination vectored vaccine Viral viral particle Viral particles virus neutralising assay virus neutralising assays was done women
[DOI] 10.1016/S1473-3099(20)30160-2 PMC 바로가기 [Article Type] Article

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 1:1 active malignancy acute respiratory distress syndrome Administered administration age approval approved ARDS assessment automated Berlin blinded Cell cell suspension cellular changes in chronic liver disease class clinical Clinical diagnosis Clinical outcome clinical outcomes clinical trial comparator Compliance conducted control group Controlled trial COVID 19 COVID-19 COVID-19 pandemic declined defined described determine diagnosis of COVID-19 dissemination Donor Dose escalation driving Effect Efficacy element eligible Elizabeth enrolled ethics committee EudraCT excluded facilitate failure fixed dose hospital ICU incidence Inclusion increase in index individual information infusion intensive care unit Intervention Invasive mechanical ventilation investigator King’s College London London Mesenchymal stem cells Mesenchymal stromal cells MHRA moderate Mortality MSC MSCs NIHR number objective open label Other outcome pandemic PaO participant Patient patient population patients with ARDS PCR test PF ratio Phase 1 Phase 2 Placebo placebo-controlled protocol protocol amendment Public randomised randomised controlled trial REC receiving recruited recruitment repair reported Research respiratory Resuscitation Sample size secondary Secondary objective Secondary outcomes Serious Adverse Events severe ARDS single intravenous infusion SOFA solution Standard steering committee stratified stromal cell Study protocol Therapeutics therapy trauma Treatment Trial triple blinded Trust umbilical United Kingdom university Venous Thromboembolism Ventilation verbal Volume web-based randomisation system website WHO Withdrawal
[DOI] 10.1186/s13063-020-04416-w PMC 바로가기 [Article Type] Letter

Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial

주로 경증에서 중등도의 코로나바이러스 질환 환자의 하이드록시클로로퀸 2019: 공개 라벨, 무작위 대조 시험

Research

Published on 2020-05-142022-08-09
Journal: The BMJ [Category] Fulltext, MERS, 임상,

[키워드] 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Adverse adverse event adverse events analysed Analysis assigned China Controlled trial coronavirus coronavirus disease Coronavirus disease 2019 covid-19 treatment centre diarrhoea dose Efficacy and safety event followed by Government group hospital Hydroxychloroquine hydroxychloroquine group hydroxychloroquine non-recipient hydroxychloroquine non-recipients hydroxychloroquine recipient hydroxychloroquine recipients Intention intention to treat laboratory confirmed covid-19 Loading dose maintenance dose Mild mild to moderate mild to moderate disease moderate moderate disease negative Negative conversion non-recipients objective open open label outcome measure participant Patient patients principle Probability randomisation randomised controlled trial recipients reported respiratory Result safety population Serious Adverse Events setting severe acute respiratory syndrome Coronavirus severe disease significantly higher Standard of care symptom onset Treatment Trial registration virus were recorded
[DOI] 10.1136/bmj.m1849 PMC 바로가기 [Article Type] Research

A Prospective Cohort Study on the Safety of Infant Pentavalent (DTwP-HBV-Hib) and Oral Polio Vaccines in Two South Indian Districts

인도 남부 지역 2곳의 유아 5가 백신(DTwP-HBV-Hib) 및 경구용 소아마비 백신의 안전성에 관한 전향적 코호트 연구

Article

Published on 2020-05-142024-07-28
Journal: The Pediatric Infectious Disease Journal [Category] 백일해, 파상풍,

[키워드] death Hospitalization oral polio vaccine pentavalent vaccine Serious Adverse Events
[DOI] 10.1097/INF.0000000000002594 PMC 바로가기