approval – Page 54 – Communicable Diseases Research

Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-06-262022-10-29
Journal: Trials [Category] COVID-19, SARS,

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

Research Article

Published on 2020-06-252022-10-28
Journal: BMC Medicine [Category] Coronavirus, Fulltext, SARS, 신종인플루엔자,

[키워드] activity affected analysed approval article Asia barriers challenges clinical Clinical research Community COVID-19 pandemic database develop dissemination Ebola virus Emerging infectious diseases Epidemic Epidemics Europe evaluate evaluated Evidence experience facilitators flexible for inclusion generate global health Government H1N1 Health IMPROVE improvement infectious disease outbreak Latin America Major mechanisms MOST National North America outbreak outcome pandemic Pandemics preparedness protocol PsycINFO Region regions Regulatory Research response responses Result screened searched solution Solutions Trial
[DOI] 10.1186/s12916-020-01624-8 PMC 바로가기 [Article Type] Research Article

Efficacy of Serology Testing in Predicting Reinfection in Patients With SARS-CoV-2

Concepts in Disaster Medicine

Published on 2020-06-242022-10-31
Journal: Disaster Medicine and Public Health Preparedness [Category] COVID-19,

Extended-Interval Dosing Strategy of Immune Checkpoint Inhibitors in Lung Cancer: Will it Outlast the COVID-19 Pandemic?

Oncology

Published on 2020-06-232022-10-31
Journal: Frontiers in Oncology [Category] COVID-19,

[키워드] absence accelerated acute respiratory syndrome approach approval approved atezolizumab backbone causative pathogen clinical evidence Community Complication coronavirus COVID-19 COVID-19 pandemic disease dose Dosing drug durvalumab Evidence extended-interval extended-interval dosage Factor FDA food hospital Hospital admission Immune checkpoint inhibitor Immune checkpoint inhibitors in silico indications Infection lung cancer majority nivolumab nosocomial oncology Outlast pandemic Patient Pembrolizumab pharmacokinetic potential risk predict Recurrent risk SARS-CoV-2 Strategy therapeutic Treatment treatment strategy Viral transmission
[DOI] 10.3389/fonc.2020.01193 PMC 바로가기 [Article Type] Oncology

Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II): protocol for an observational study using linked Scottish national data

Infectious Diseases

Published on 2020-06-212022-10-28
Journal: BMJ Open [Category] COVID-19, Fulltext, SARS,

[키워드] acute respiratory syndrome adverse events Analysis antimicrobial antimicrobial drug approval association attack rate Characteristics Committee coronavirus COVID-19 COVID-19 epidemic COVID-19 pandemic Cox model dataset death determine dissemination Effectiveness enhanced Epidemiology Ethics evaluate expand healthcare highest hospitalisation individual International Intervention Laboratory laboratory data MONITOR morbidity and mortality Mortality multivariate logistic regression National pandemic peer-reviewed platform Poisson regression models preventive intervention primary care Primary outcome prospective observational cohort protective effect protocol public health Registered required respiratory medicine (see thoracic medicine) risk SARS-CoV-2 SARS-COV-2 infection Scottish secondary outcome service Study design Surveillance therapeutic therapeutic intervention Therapies Vaccine
[DOI] 10.1136/bmjopen-2020-039097 PMC 바로가기 [Article Type] Infectious Diseases

AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial

AGILE-ACCORD: COVID-19 치료를 위한 여러 후보 약제의 최적 용량, 안전성 및 효능을 결정하기 위한 무작위, 다기관, 원활한, 적응 I/II상 플랫폼 연구: 무작위 플랫폼에 대한 연구 프로토콜의 구조화된 요약 재판

Letter

Published on 2020-06-192022-08-13
Journal: Trials [Category] SARS, 임상,

[키워드] 9-point ordinal scale acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adaptive added Adult patients Adverse adverse events agent Anti-viral treatment approval Bayesian Blinding candidate Candidates clinical Clinical improvement cloud Cohort cohorts Combination Common Terminology Criteria Community community setting comparator contributing to coronavirus COVID-19 COVID-19 infection CST cytokine cytokine release death defined determine disease dissemination dose EDC Efficacy Efficacy and safety element eligibility criteria eligible England EudraCT evaluated expected for inclusion futility GRADE group hospitalised hospitalised patient Hospitalization in some include Infection intubation Ireland laboratory-confirmed later phase limit Mask Master protocol mechanical ventilation mechanism mechanism of action multi-arm multicentre Multiple nasal prongs non-invasive ventilation North number objective open Open-label opens optimal dose Ordinal Scale organ Other outcome oxygen oxygen saturation oxygen) participant Patient patient population patients peripheral capillary Peripheral capillary oxygen saturation phase Phase I/II Placebo platform Platform study Platform trial Population Prevent progression of disease promise protocol randomisation randomised Rave recruited recruitment Regulatory required respiratory Safety Sample size SARS-CoV-2 SARS-COV-2 infection seamless setup severe acute respiratory syndrome Coronavirus severe disease shown SOC Specific Stage Standard Standard of care status Study protocol the WHO toxicities Toxicity Treatment treatment of COVID-19 Trial Trial registration Ventilation Viral Viral load viral replication website WHO working
[DOI] 10.1186/s13063-020-04473-1 PMC 바로가기 [Article Type] Letter

A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol

Letter

Published on 2020-06-082022-10-29
Journal: Trials [Category] COVID-19, SARS,

[키워드] 1:1 24 hour 28-day mortality activated acute respiratory distress syndrome Administered Admission adverse effect age albumin allergic allocation concealment Anticoagulant apheresis approval approved assessment Basel block size C-reactive protein category changes in city Coagulopathy Control COVID-19 COVID-19 disease criteria Cytokine release syndrome D-dimer defined disease dissemination drug eight element Enrollment evaluate evaluated ferritin fibrinogen first dose FIVE food function group ICU ICU admission ill patient Improving Inc. Inflammatory ingredient intensive care intensive care unit International Intervention intervention group intubation IRB ISRCTN KDIGO King Kingdom Laboratory lack lactate dehydrogenase life threatening life-threatening Life-threatening COVID-19 marker measure Mild Ministry of Health Multicenter trial Multisystem organ failure National negative RT-PCR normalized number objective occur on mechanical ventilation Open-label outcome Palliative care participant Participants Patient patients performed pilot study plasma primary site Prothrombin time protocol Qiagen randomization randomize Randomized Randomized controlled trial randomized trial Real-time PCR receive receiving recommendations recruit reduce replaced Roche RT-PCR RT-PCR kit Safety Sample size SARS CoV-2 SARS-CoV-2 SARS-COV-2 infection Saudi Arabia secondary serum Seven sodium SOFA status Stratification Study protocol supportive care Switzerland System Therapeutic plasma exchange therapy TPE treatment for COVID-19 tumor necrosis factor-alpha USA Volume website
[DOI] 10.1186/s13063-020-04454-4 PMC 바로가기 [Article Type] Letter

Physicochemical properties of SARS‐CoV‐2 for drug targeting, virus inactivation and attenuation, vaccine formulation and quality control

Review

Published on 2020-06-082022-10-31
Journal: Electrophoresis [Category] COVID-19, SARS,

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

Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: 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 allocation analyzed anticipated approval blinded clinical symptom clinical trial Complete conducted Confirmed Contact Control control group COVID COVID-19 COVID-19 virus criteria dissemination dosage dose double-blind drug Dyspnea Effect element enzyme deficiency Epidemic Fever G6PD healthcare Healthcare professional healthcare professionals history hospital Hydroxychloroquine hypersensitivity independent Infection intervention group Iran Medical Sciences myalgia nausea number objective outcome participant Patient PCR pharmaceutical Pharmacy Placebo placebo-controlled trial polymerase chain reaction Prevent prevention prevention of COVID-19 Primary outcome protocol random randomised randomised controlled trial randomization randomization list Randomized recruitment researcher Sample size statistical status Study protocol Tablet Tehran treatment allocation treatment group Trial Trial registration underlying disease university virus virus infection website
[DOI] 10.1186/s13063-020-04439-3 PMC 바로가기 [Article Type] Letter