Ordinal Scale – Page 5 – Communicable Diseases Research

Complement Overactivation and Consumption Predicts In-Hospital Mortality in SARS-CoV-2 Infection

보완 과잉 활성화 및 소비는 SARS-CoV-2 감염의 병원 내 사망률을 예측합니다

Clinical Trial

Published on 2021-03-252022-08-13
Journal: Frontiers in Immunology [Category] SARS, 임상,

Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

우리 국가를 위한 수동 면역 시험(PassITON): 입원한 성인에서 COVID-19 회복기 혈장을 평가하는 무작위 위약 대조 임상 시험을 위한 연구 프로토콜

Study Protocol

Published on 2021-03-202022-09-10
Journal: Trials [Category] SARS, 임상, 치료기술,

[키워드] 1:1 7-category ordinal scale activity Administered adults hospitalized blinded chimeric Clinical efficacy clinical status clinical trial clinical trials conducted convalescent plasma coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 convalescent plasma COVID-19 patient daily living demonstrated detect Efficacy eligible Evidence Hospitalized include indicated less moderate moderate to severe Mortality multicenter nation Neutralizing antibodies neutralizing function normal activities Odds ratio Ordinal Scale oxygen oxygen-free days pandemic Pandemics Pass Passive passive immunity Patient placebo-controlled plasma Primary outcome Randomized randomized clinical trial Randomized controlled trial respiratory Respiratory Support respiratory symptom respiratory symptoms robust SARS-CoV-2 SARS-CoV-2: convalescent plasma secondary outcome severe COVID-19 Study protocol supplementary material symptomatic disease These data Treatment treatment of COVID-19 patients Trial Trial registration USA Viral Virus neutralization with COVID-19
[DOI] 10.1186/s13063-021-05171-2 PMC 바로가기 [Article Type] Study Protocol

Itraconazole for COVID-19: preclinical studies and a proof-of-concept randomized clinical trial

COVID-19에 대한 이트라코나졸: 전임상 연구 및 개념 증명 무작위 임상 시험

Randomized Controlled Trial

Published on 2021-03-192022-08-13
Journal: EBioMedicine [Category] MERS, SARS, 비임상, 신약개발, 임상, 진단, 치료제,

[키워드] 7-point ordinal scale 95% CI absence acute infection acute SARS-CoV-2 infection adequate plasma antifungal drug itraconazole antivirals assigned breath Caco-2 clinical status Clinical studies clinical study clinical trial COVID-19 cumulative score did not reduce drug concentrations Drug repurposing effective evaluated finding foundation funding geometric Geometric means Health Organization Horizon hospitalized COVID-19 patient hospitalized COVID-19 patients human Caco-2 cells ileum in vitro activity initial interim analysis itraconazole Leuven lung Lungs Melinda Gate Melinda Gates not effective Open-label Ordinal Scale outcome Preclinical preclinical studies preclinical study premature termination Prevent prevention of COVID-19 Primary outcome proof-of-concept clinical study randomized clinical trial Randomly required SARS-CoV-2 SARS-COV-2 infection showed no signal single-center study Standard of care Stool stools Transmission Transmission model Treatment Vero Viral Viral load viral load in lungs Viral transmission World Health Organization
[DOI] 10.1016/j.ebiom.2021.103288 PMC 바로가기 [Article Type] Randomized Controlled Trial

COVIDENZA – A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial

COVIDENZA - 코로나 바이러스 질병 2019(COVID-19) 환자의 이환율을 감소시키기 위한 엔잘루타미드 치료의 전향적, 다기관, 무작위 PHASE II 임상 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-03-162022-09-10
Journal: Trials [Category] SARS, 임상, 치료제,

[키워드] 7-point ordinal scale age androgen Androgen receptor androgen signalling antiandrogen anticipated approved Blinding Breast cancer breast-feeding cardiovascular disease center clinical trial comparator comparator Patients Complete connection Corona virus COVID-19 COVID-19 patient COVID-19 symptom COVID-19 symptoms decrease discharge disease dissemination element enzalutamide enzyme evaluate exclusion criteria expression FIVE focus followed by for inclusion hospital hospitalised host cell Hypothesis Identifier identify immunosuppressive drugs IMPROVE include Inclusion independent intensive care interim analysis Laboratory Major majority male mechanical ventilation men morbidity multicenter multicentre North number objective observation Open-label open-label trial Ordinal Scale outcome participant Participants Patient PCR Placebo power pregnant women primary endpoint primary endpoints PROC Prostate protocol randomisation list randomised randomised controlled trial Randomized receptor Region Registered Sample size SARS-CoV-2 host cell SAS Institute SAS version 9.4 Sex Standard of care status stratified Study protocol subject supplementary material symptomatic Testosterone TMPRSS2 to define treated Treatment treatment arm Trial university Västerbotten website with COVID-19 women
[DOI] 10.1186/s13063-021-05137-4 PMC 바로가기 [Article Type] Letter

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

코로나19 입원 환자를 위한 중화 단일클론항체

Randomized Controlled Trial

Published on 2021-03-112022-09-11
Journal: The New England Journal of Medicine [Category] Fulltext, MERS, 임상, 진단, 치료제,

[키워드] 1:1 95% CI 95% confidence interval addition Administered adverse event all the patients antibody antiviral drug assigned categories category Composite coronavirus disease Coronavirus disease 2019 Data and Safety Monitoring Board death decrease dose Efficacy emergency department end-organ Enrollment Frequency futility Glucocorticoids grade 3 Hospitalization hospitalizations Hospitalized hospitalized patient hospitalized patients in viral indicated infusion interquartile range intravenous infusion LY-CoV555 matching placebo median interval monitoring board monoclonal antibody Neutralizing Odds ratio onset of symptom operation Ordinal Scale outcome Outpatient outpatients oxygen Patient Placebo placebo group Platform trial Primary outcome Pulmonary function randomization Randomly rate ratio receive Remdesivir Serious Adverse Events Seven seven-category ordinal scale single intravenous infusion speed supplemental oxygen supportive care sustained the patient the placebo group therapeutic agents therapy time-to-event analysis Viral Viral load was performed
[DOI] 10.1056/NEJMoa2033130 PMC 바로가기 [Article Type] Randomized Controlled Trial

Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

신종 코로나바이러스에 대항하는 직접 항바이러스제: 아지스로마이신(DAWn-AZITHRO), 무작위, 다기관, 공개 라벨, 적응형, SARS-CoV-2에 대해 작용하는 새로운 항바이러스제의 개념 증명 임상 시험 - 아지스로마이신 시험

Study Protocol

Published on 2021-02-092022-09-10
Journal: Trials [Category] MERS, 임상, 치료제,

[키워드] 7-category ordinal scale adaptive Admission amplify antibiotic Antiviral Antiviral effect Azithromycin Belgium blunt Bronchoalveolar lavage Care chance chest CT scan clinical Clinical improvement clinical trial coronavirus SARS-CoV-2 Course COVID COVID-19 COVID-19 disease cytokine cytokine signaling decrease defined diagnosed with COVID-19 Diagnosis Direct discharge disease disease course drug Efficacy eligible EudraCT feature health regulations Hospitalized hospitalized patient hospitalized patients Hydroxychloroquine hyperinflammatory state immunomodulatory properties implicated in vitro include Inclusion Intervention life Local Macrolide medical need multicenter name Nasopharyngeal swab National Novel coronavirus novel coronavirus SARS-CoV-2 Open-label Ordinal Scale pathway Pathways Patient patients patients with COVID-19 PCR Phase 2 Primary outcome proof-of-concept clinical trial radiological Randomized Randomized controlled trial receive recruit SARS-CoV-2 severe COVID-19 disease shown Standard Standard of care study inclusion supplementary material Support sustained symptomatic the disease the WHO treatment effect treatment effects treatment group treatment strategy Trial Viral viral replication widespread with COVID-19
[DOI] 10.1186/s13063-021-05033-x PMC 바로가기 [Article Type] Study Protocol

Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial

코로나바이러스 감염증(COVID-19) 감염이 확인된 병원에 입원한 환자의 레닌-안지오텐신-알도스테론 시스템 차단 관리(The McGill RAAS-COVID-19): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Study Protocol

Published on 2021-02-052022-09-10
Journal: Trials [Category] MERS, 임상,

[키워드] 1:1 48 hour 48 hours ACE inhibitor ACE2 Acute kidney injury Admission age aldosterone All participants Amendment Analysis Anticoagulants approach assigned baseline Biomarker Biomarkers blinded Blinding blockade blood pressure BNP C-reactive protein C-reactive protein (CRP calculated calibrated cardiovascular disease change Clinical improvement clinical trials collected comparator component Consent coronavirus disease COVID-19 COVID-19 diagnosis COVID-19 infection COVID-19 patient creatinine creatinine) CRP database death diagnosis of COVID-19 died discharge dissemination domains doubling Effect EGFR Ejection fraction element eligible Endpoint enrolment Estimated Ethnicity evaluate event exclusion criteria feasibility Follow-up followed by General Hospital greater groups Health Health Organization heart failure high blood pressure highest hospital ICU ICU admission immunopathology include Inclusion inclusion and exclusion criteria increase increase in Increases indicate Infection inhibitor inhibitors initial initiated intervention arm intravenous invasive ventilation list Lower lowest lymphocyte Lymphocyte count lymphocyte counts mathematical mathematical model McGill University mean rank mechanical ventilation medical history medication medications meet Montreal Mortality number objective Older open open label Ordinal Scale outcome outcomes participant Participants past medical history Patient patient cohort PCR performed Prevent primary end point primary endpoint Protein protocol provided RAAS RAAS inhibitor random number generator randomised randomised controlled trial randomization Randomized Randomized controlled trial recruitment reduced Registration Renin required Sample Sample size SARS- CoV2 secondary secondary endpoint sensitivity sensitivity analysis serum creatinine Sex short term stability statistical power calculations status stroke study participant Study protocol subsequent supplementary material System table team the patient the primary endpoint therapy transfer transferred Treatment Trial troponin Version Victoria ward website were excluded WHO withdrawn World Health Organization
[DOI] 10.1186/s13063-021-05080-4 PMC 바로가기 [Article Type] Study Protocol

Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial

SARS-CoV-2 감염 치료를 위한 흡입 분무 인터페론 베타-1a(SNG001)의 안전성 및 효능: 무작위 배정, 이중 맹검, 위약 대조, 2상 시험

Clinical Trial

Published on 2021-02-012022-09-11
Journal: The Lancet. Respiratory Medicine [Category] 임상, 치료제,

[키워드] 1:1 activities acute respiratory syndrome acute respiratory syndrome coronavirus adverse event adverse events Analysis assigned clinical clinical condition Clinical improvement clinical trials coronavirus COVID-19 symptoms death dose double-blind during treatment Efficacy Efficacy and safety FIVE greater hazard ratio headache hospital identify improvement Infection inhalation Inhaled Inpatient Inpatients intention-to-treat population interferon Interferon beta-1a MIU Multiple nine no infection Odds ratio Older Ordinal Scale oxygen oxygen supplementation Patient Phase 2 phase 2 trial Placebo placebo group placebo-controlled point-of-care positive RT-PCR Primary outcome randomised Randomly receive receiving Registered reported required respiratory Safety SARS-CoV-2 SARS-COV-2 infection scale Seven severe acute respiratory syndrome Coronavirus severe acute respiratory syndrome coronavirus 2 statistical study drug substantial risk Symptoms the placebo group the WHO those receiving placebo Treatment treatment-emergent adverse event Trial trials WHO ordinal scale with COVID-19
[DOI] 10.1016/S2213-2600(20)30511-7 PMC 바로가기 [Article Type] Clinical Trial

Tocilizumab for the treatment of adult patients with severe COVID-19 pneumonia: A single-center cohort study

중증 COVID-19 폐렴 성인 환자의 치료를 위한 Tocilizumab: 단일 센터 코호트 연구

Article

Published on 2021-02-012022-09-11
Journal: Journal of medical virology [Category] MERS, SARS, 진단, 치료제,

[키워드] 6-point ordinal scale 95% confidence interval adjusted odds ratio adverse events all-cause mortality analyzed Body body temperature C-reactive protein cardiac rate cardiac rates clinical Clinical improvement clinical status cohort study consecutive patient coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 pneumonia cytokine release decrease dose dropped Evidence hospital discharge hyperinflammatory phase immunomodulation immunomodulatory therapy interferon intravenous Laboratory Lactate lactate dehydrogenase lead lymphocyte Lymphocyte count monoclonal antibody Mortality Ordinal Scale outcome oxygen oxygen saturation Patient Pneumonia Primary outcome pulse oximetry Rate receptor respiratory Safe SARS-CoV-2 secondary Secondary outcomes serum lactate severe COVID-19 Severe COVID-19 pneumonia significantly single-center single-center study TCZ temperature Tocilizumab Treatment vital sign vital signs with COVID-19
[DOI] 10.1002/jmv.26308 PMC 바로가기 [Article Type] Article

Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

입원 환자의 COVID-19 치료에 대한 회복기 혈장 대 치료 표준 평가: 2상 무작위, 공개, 대조, 다기관 시험을 위한 연구 프로토콜

Study Protocol

Published on 2021-01-202022-09-10
Journal: Trials [Category] MERS, 임상,

[키워드] 1:1 7-point ordinal scale Acute respiratory infection acute respiratory infections Administered Adult patients Analysis antibodies assigned cause caused center clinical trial Complete conducted contribute Controlled trial convalescent plasma Convalescent plasma (CP) COVID-19 COVID-19 infection COVID-19 pneumonia effective Efficacy Efficacy and safety enrolled etiology evaluate expected futility Hospitalized hospitalized patients immune response Immunotherapy include infected patient infected patients Interim Interim analyses intravenously invasive mechanical ventilation morbidity and mortality multicenter Multicenter trial Neutralizing antibodies Non-invasive Novel coronavirus Open-label option Ordinal Scale Patient patients hospitalized pharmacological primary endpoint proportion protocol Randomized Randomly receive respiratory Respiratory disease Sample size SARI SARS-CoV-2 Severe COVID-19 Infection Severe COVID-19 pneumonia severity Standard of care stratified Study protocol supplementary material the WHO therapeutic agent therapeutic agents Therapeutics Treatment treatment arm Trial registration Vaccine variety Viral viral disease with COVID-19
[DOI] 10.1186/s13063-020-05011-9 PMC 바로가기 [Article Type] Study Protocol