Ordinal Scale – Page 7 – Communicable Diseases Research

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,

Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

중증 코로나19 환자에게 5일 또는 10일 동안 렘데시비르 투여

Clinical Trial

Published on 2020-11-052022-09-11
Journal: The New England Journal of Medicine [Category] SARS, 비임상,

[키워드] 1:1 7-point ordinal scale Alanine alanine aminotransferase animal model animal models antiviral activity assigned baseline benefit breath breathing ambient air can not Clinical improvement clinical status common adverse event conducted constipation coronavirus disease Coronavirus disease 2019 Course Day distribution duration of treatment Efficacy elevated Evidence evidence of hospitalized patient hospitalized patients in vitro interquartile range Intravenous remdesivir less magnitude mechanical ventilation median nausea occurred once daily Open-label Ordinal Scale oxygen oxygen saturation Patient patients phase 3 trial Placebo Pneumonia primary end point radiologic randomization Randomized Randomly receive Remdesivir Respiratory failure RNA polymerase inhibitor SARS-COV-2 infection severe COVID-19 significant difference significantly subsequent Treatment Trial worsening respiratory failure
[DOI] 10.1056/NEJMoa2015301 PMC 바로가기 [Article Type] Clinical Trial

Development of a multivariate prediction model of intensive care unit transfer or death: A French prospective cohort study of hospitalized COVID-19 patients

중환자실 이송 또는 사망의 다변수 예측 모델 개발: 입원한 COVID-19 환자에 대한 프랑스 전향 코호트 연구

Research Article

Published on 2020-10-192022-08-13
Journal: PLoS ONE [Category] Biochemistry, COVID-19, MERS, SARS,

[키워드] 9-point ordinal scale 95% CI acute respiratory syndrome Admission age C-index calibration calibration curve Care Chain Reaction clinical clinical scale cohort study coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patient death defined Department development discharge discrimination European population evaluated Factor France French Health Organization hospital Hospitalized hospitalized COVID-19 patient ICU identify increased risk intensive care intensive care unit internal internal medicine laboratory-confirmed lymphocyte Lymphocytes management Medicine moderate multivariable logistic regression multivariable logistic regression models Older age Ordinal Scale outcome Paris Patient patients patients hospitalized positive predicted Probability Prognostic factor Prognostic factors prospective cohort study R 2 respiratory reverse transcriptase risk scoring system single-center transfer university hospital Ventilation was performed were assessed WHO World Health Organization
[DOI] 10.1371/journal.pone.0240711 PMC 바로가기 [Article Type] Research Article

Canakinumab to reduce deterioration of cardiac and respiratory function in SARS‐CoV‐2 associated myocardial injury with heightened inflammation (canakinumab in Covid‐19 cardiac injury: The three C study)

염증이 고조된 SARS-CoV-2 관련 심근 손상에서 심장 및 호흡 기능의 악화를 감소시키는 카나키누맙(Covid-19 심장 손상에서의 카나키누맙: 3개의 C 연구)

Trial Designs

Published on 2020-08-242022-09-10
Journal: Clinical Cardiology [Category] MERS, SARS, 바이오마커, 임상, 진단,

[키워드] anticipated baseline characteristics C‐reactive protein canakinumab cardiac cardiac injury Characteristics Controlled trial COVID‐19 CRP defined Deterioration discharge dysfunction elevated Elevation elevations enrolled evaluate hospital Hospitalized hospitalized COVID‐19 patients hyperlipidemia hypertension Hypothesis IMPROVE Inflammation male median morbidity morbidity and mortality Mortality myocardial injury occur Ordinal Scale outcome Patient Placebo Prevalence Prevent primary endpoint progressive respiratory failure randomization Randomized controlled trial randomized patient reduce Respiratory failure Respiratory function Result SARS‐CoV‐2 SARS‑CoV2 SARS‐CoV2 infection SARS‐CoV‐2 secondary endpoint Seven Time to recovery Treatment troponin troponin T worsening
[DOI] 10.1002/clc.23451 PMC 바로가기 [Article Type] Trial Designs

Compassionate use of JAK1/2 inhibitor ruxolitinib for severe COVID-19: a prospective observational study

중증 COVID-19에 대한 JAK1/2 억제제 룩소리티닙의 동정적 사용: 전향적 관찰 연구

Clinical Trial

Published on 2020-08-192022-08-13
Journal: Leukemia [Category] MERS, SARS, 바이오마커, 신약개발, 임상, 치료제,

[키워드] 95% confidence interval activated adverse event age Anemia anti-inflammatory properties clinical Clinical improvement Comorbidities Comorbidity compassionate-use compassionate-use protocol contribute Controlled clinical trial controlled clinical trials COVID-19 cumulative incidence cytokine defined discharge home distress Efficacy exposure time FiO2 high-flow oxygen support improvement Infectious diseases Inflammatory cytokine inflammatory cytokine profile inflammatory reaction inhibitor JAK1 JAK1/JAK2 inhibitor JAK2 less lymphocyte Lymphocyte subset median age median dose intensity not affected observational study Ordinal Scale overall survival oxygen oxygen saturation PaO2 paO2/fiO2 PaO2/FiO2 ratio Patient patients with COVID-19 prospective cohort prospective observational study pulmonary disease Pulmonary function pulmonary infiltrate pulmonary infiltrates respiratory distress ruxolitinib Safe severe COVID-19 severe pulmonary disease Therapeutics thrombocytopenia urinary tract infections
[DOI] 10.1038/s41375-020-01018-y PMC 바로가기 [Article Type] Clinical Trial

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

Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial

당뇨병과 같은 동반 질환이 없는 새로 진단된 COVID-19 감염 환자를 치료하기 위한 Hydroxychloroquine, Oseltamivir 및 Azithromycin의 코로나바이러스 치료(PROTECT) 평가를 위한 파키스탄 무작위 및 관찰 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

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

[키워드] 1:1 adaptive age allocation sequence approval authority Azithromycin baseline bioethics blinded Blinding board clinical Clinical improvement clinical status Cohort cohort study Combination combinations Committee Comorbidity comparator computer-generated Controlled trial coronavirus COVID-19 diabete diabetes Diabetes Mellitus diagnosed disease dissemination distress drug dyspneic Effectiveness eight element evaluate excluded expected Final flexibility Follow-up followed by Formal Gender groups Hospitalized Hydroxychloroquine hypertension Infection intervention group kidney Kidney failure lactating liver medical condition monotherapy multi-center multicenter nasal swab nucleic acid number objective observation open open label Ordinal Scale oseltamivir parameter participant patients patients with COVID-19 PCR positive pregnant Primary outcome Primary outcomes protocol public health qRT-PCR random randomization Randomized Randomized controlled trial randomized study recruited recruitment regimen Registered Registration reported respiratory distress Safety Sample size Self-isolation Seven seven-category ordinal scale Standard status Study protocol subject subsequent sulfate test negative tested three groups treat Treatment Trial twice a day Version virus website
[DOI] 10.1186/s13063-020-04616-4 PMC 바로가기 [Article Type] Letter

ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trial

ACCORD: 입원 환자의 COVID-19 치료를 위한 여러 후보 약제의 효능과 안전성을 평가하기 위한 다기관, 원활한, 2상 적응형 무작위화 플랫폼 연구: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2020-07-312022-08-13
Journal: Trials [Category] SARS, 임상,

[키워드] 1:1 a BTK inhibitor Acalabrutinib adaptive added adjusted agent Amendment analyses Analysis Anti-viral approval Arm baseline bemcentinib Blinding block BTK inhibitor candidate Candidates cause caused changed clinical Clinical characteristics Clinical improvement clinically comparator complement COVID COVID-19 current Day discharge disease dissemination dropped Efficacy element Endpoint England estimation EudraCT evaluate Evidence evidence of experimental arm GRADE group help heparin hospital hospitalised include Inflammatory response inhibitor Ireland IRT Mask Master protocol Mild Mild disease monoclonal antibody Multiple nasal prongs National non-invasive ventilation number objective open open label Ordinal Scale outcome oxygen Oxygen therapy oxygen therapy) participant Patient performed Phase 2 phase II platform proceed protocol protocols provide randomisation randomised randomised controlled randomised controlled trial randomization recruited recruitment reduce Registered Regulatory reported Respiratory failure response response rate Safety Sample size SARS-COV-2 infection SARS-CoV-2 spike SARS-CoV-2 spike protein seamless selected severity shown SOC Spike protein Stage stage 2 stages Standard of care status stratified Study protocol sustained Task Force technology the spike protein the WHO therapy time treat Treatment treatment of COVID-19 Trial Trial registration Viral viral infection virus website with COVID-19 working zilucoplan
[DOI] 10.1186/s13063-020-04584-9 PMC 바로가기 [Article Type] Letter

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

Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial

중증 COVID-19 성인 환자에 대한 정맥 주사 렘데시비르의 효능 및 안전성 평가: 무작위 배정, 이중 맹검, 위약 대조, 다기관 임상 3상 연구 프로토콜

Study Protocol

Published on 2020-05-242022-09-10
Journal: Trials [Category] MERS, SARS, 비임상,

[키워드] Administered Administrative information Adult patients Antiviral assigned asymptomatic infection breath category caused China Clinical efficacy Clinical improvement clinical manifestation clinical manifestations clinical status clinical trial concern conducted coronavirus disease Coronavirus disease 2019 Coronavirus infections Coronaviruses COVID-19 COVID-19 virus death defined discharge double-blind Efficacy Efficacy and safety Emergency enrolment event futility GS-5734 Health Organization highly pathogenic hospital in vitro in vivo experiments include Infection inhibitory inhibitory effect Inhibitory effects interim analysis Intravenous remdesivir intravenously laboratory-confirmed MERS-CoV Mild multicentre nucleoside Ordinal Scale Patient Phase 3 Placebo placebo-controlled placebo-controlled trial Pneumonia primary endpoint protocol Public public health emergency randomization Randomized Randomly Remdesivir reported required Respiratory failure SARS-CoV SARS-CoV-2 virus severe COVID-19 severe pneumonia severe viral pneumonia Spread Standard Study protocol Symptoms Treatment Trial Trial registration upper respiratory symptoms Viral Viral pneumonia virus infection World Health Organization Wuhan
[DOI] 10.1186/s13063-020-04352-9 PMC 바로가기 [Article Type] Study Protocol