Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial계층적 복합 종점을 기반으로 한 연구의 설계 및 분석: DARE-19 시험의 통찰력Article Published on 2022-09-012022-09-11 Journal: Therapeutic innovation & regulatory science [Category] 임상, [키워드] accompanied Analysis analyzed cardiometabolic Cardiometabolic risk factors clinical endpoint Clinical endpoints Clinical outcome clinical outcomes clinically component components Composite composite endpoint COVID-19 COVID-19 pneumonia Dapagliflozin described detectable disease Effect Endpoint example flexible handling Hierarchical composite endpoints hospitalized patient hospitalized patients ICH include inhibitor insight Interpretation mechanism mechanism of action Missing data offered Pneumonia power primary endpoints randomized trial ranking Sample size SGLT2 inhibitors statistical suggested the primary endpoint therapeutic to define Treatment Trial Win odds. with COVID-19 [DOI] 10.1007/s43441-022-00420-1 PMC 바로가기 [Article Type] Article
Remdesivir Plus Dexamethasone Versus Dexamethasone Alone for the Treatment of Coronavirus Disease 2019 (COVID-19) Patients Requiring Supplemental O2 Therapy: A Prospective Controlled Nonrandomized Study코로나바이러스 질병 2019(COVID-19) 환자 치료를 위한 렘데시비르 플러스 덱사메타손 대 덱사메타손 단독 요법: 보충 O2 요법이 필요한 환자: 전향적 통제된 비무작위 연구Controlled Clinical Trial Published on 2022-08-242022-09-11 Journal: Clinical Infectious Diseases: An Official Publicat [Category] SARS, 임상, 치료제, [키워드] 30-Day mortality Antiviral baseline calculated clinical outcomes cohorts Combination Controlled coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patient CRP D-dimer Dexamethasone drug effective Endpoint enrolled evaluate evaluated faster fibrinogen FiO2 group groups Hospitalization IMPROVE independent Inflammatory inflammatory markers Kaplan-Meier Kaplan-Meier curve Kaplan-Meier curves laboratory characteristics log-rank test median Mortality neutrophil neutrophil/lymphocyte ratio no differences occurred primary endpoint primary endpoints Prospective reducing mortality reduction in reduction in mortality Remdesivir Respiratory failure Respiratory function Sample size SARS-CoV-2 clearance secondary Secondary endpoints shown significant difference significant differences survival the log-rank test therapy treat Treatment viral clearance Viral clearance. were used [DOI] 10.1093/cid/ciac014 PMC 바로가기 [Article Type] Controlled Clinical Trial
Screening and assessment for post-acute COVID-19 syndrome (PACS), guidance by personal pilots and support with individual digital trainings within intersectoral care: a study protocol of a randomized controlled trial급성 COVID-19 이후 증후군(PACS)에 대한 선별 및 평가, 개인 파일럿의 지도 및 부문 간 치료 내 개별 디지털 교육 지원: 무작위 대조 시험의 연구 프로토콜Article Published on 2022-08-152022-09-11 Journal: BMC Infectious Diseases [Category] SARS, 임상, [키워드] active control group activities activity applicability assigned both group both groups can be used Care chatbot comparability COVID-19 COVID-19 infection Cross-sectoral care Diagnosis Digital Digital therapy offers empowerment Endpoint evaluate evaluated example facilitate feasibility Guidance help helping Identifier IMPROVE Interdisciplinary diagnostic International Intervention intervention group long-COVID Low-threshold screening Medical rehabilitation outcome participant Participants Patient physiological platform Post-acute COVID-19 syndrome Post-COVID primary endpoints propensity score matching Psychological Randomized controlled trial Randomly receive recruited reduce reduction Registration Research return screened Screening secondary Secondary outcomes Study protocol Support supported Symptom Symptom assessment. Symptoms syndrome therapy Treatment Trial registration [DOI] 10.1186/s12879-022-07584-z PMC 바로가기 [Article Type] Article
Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial건강한 성인을 대상으로 한 단일 용량 V590(rVSV-SARS-CoV-2 Vaccine)의 근육 내 안전성 및 면역원성: 1상 무작위 배정, 이중 맹검, 위약 대조, 용량 범위 시험 결과Clinical Trial Published on 2022-08-012022-09-11 Journal: EBioMedicine [Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료법, [키워드] Administered administration Adults adverse event adverse events AEs anti-SARS-CoV-2 Antibody responses comparable COVID-19 COVID-19 vaccine Day dose double-blind Endpoint fatigue global pandemic headache healthy highest dose immunogenicity Inc. Injection-site pain intramuscular lower dose neutralisation neutralising antibody response Older overcome Part participant pfu Phase 1 phase 1 study Placebo placebo-controlled plaque plaque-forming unit plaque-forming units primary endpoints PRNT50 randomised receive reduction Registration reported Result Safety SARS-CoV-2 SARS-CoV-2 nucleocapsid seronegative seronegative participant seronegative participants seropositive serum Sharp spike-specific antibody response stomatitis subsidiary Trial USA V590 Vaccine vesicular stomatitis vesicular stomatitis virus Vesicular stomatitis virus (VSV). virus VSV [DOI] 10.1016/j.ebiom.2022.104138 PMC 바로가기 [Article Type] Clinical Trial
Low-Dose Whole Lung Irradiation for Treatment of COVID-19 Pneumonia: A Systematic Review and Meta-AnalysisReview article Published on 2022-08-012022-10-05 Journal: International journal of radiation oncology, biolo [Category] 임상, 치료법, [키워드] 95% confidence interval applicability Bacterial calculated clinical trial COVID-19 COVID-19 pandemic database Follow-up forest plot group had no hazard ratio high risk irradiation low-dose lung material mean difference Meta-analysis Mild moderate moderate-to-severe COVID-19 outcome Patient patients patients with COVID-19 performed Pneumonia primary endpoints produced radiation therapy random-effects model receiving reported Result review significant effect survival survival rate systematic review Treatment were assessed [DOI] 10.1016/j.ijrobp.2022.04.043 [Article Type] Review article
Clinical and laboratory predictors at ICU admission affecting course of illness and mortality rates in a tertiary COVID-19 center3차 COVID-19 센터의 질병 경과 및 사망률에 영향을 미치는 ICU 입원 시 임상 및 실험실 예측 변수Observational Study Published on 2022-05-012022-09-11 Journal: Heart & lung : the journal of critical care [Category] COVID19(2023년), SARS, 바이오마커, 신약개발, 임상, 치료기술, [키워드] Admission affected affecting age Analysis analyzed applied Arterial hypertension bacterial superinfections baseline clinical clinical feature Clinical features Cohort Comorbidities congestive heart failure Course COVID-19 COVID-19 patient COVID-19 patients Critical care Critically ill critically ill COVID-19 patients Croatia CRP determine Factor Features hospital hypertension ICU ICU admission IL-6 increase Inflammatory biomarker Invasive mechanical ventilation Laboratory laboratory parameter Laboratory parameters Length Mortality mortality rate mortality rates mortality risk multivariate adjustment outcome PaO predict predictor primary endpoint primary endpoints Regression model retrospective risk factor Risk factors Serum ferritin SOFA SOFA score survival survival analysis survival analysis. survival rates Survivors therapeutic intervention therapeutic interventions treated Trial utility [DOI] 10.1016/j.hrtlng.2022.01.013 PMC 바로가기 [Article Type] Observational Study
Immunogenicity of BNT162b2 vaccine against the Alpha and Delta variants in immunocompromised patients with systemic inflammatory diseases전신 염증성 질환이 있는 면역 저하 환자에서 알파 및 델타 변이체에 대한 BNT162b2 백신의 면역원성Article Published on 2022-05-012022-09-11 Journal: Annals of the rheumatic diseases [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] abrogated Alpha alpha and delta variants analysed anti-spike antibodies anti-spike antibody anti-Spike IgG B-cell B.1.617.2 BNT162b2 BNT162b2 vaccine Breakthrough infection breakthrough infections Control controls COVID-19 Delta delta variant Delta variants dose effort Endpoint evaluate exhibiting healthcare humoral Humoral response Immune escape immunocompromised individual immunocompromised individuals Immunocompromised patient Immunocompromised patients immunogenicity impairing IMPROVE individual infected with SARS-CoV-2 Inflammatory diseases Kinetics methotrexate mounted neutralisation neutralising Neutralising activity of BNT162b2 Other Patient primary endpoints Prospective raise regimen responses rituximab SARS-CoV-2 secondary Secondary endpoints sera Seroconversion Specific T-cell response strain Strains Support systemic inflammatory disease systemic inflammatory diseases T-cell T-cell Response T-cell responses therapeutic treated vaccination vaccination. Vaccine Viral viral fitness [DOI] 10.1136/annrheumdis-2021-221508 PMC 바로가기 [Article Type] Article
Phase I interim results of a phase I/II study of the IgG-Fc fusion COVID-19 subunit vaccine, AKS-452IgG-Fc 융합 COVID-19 서브유닛 백신 AKS-452에 대한 I/II상 연구의 I상 중간 결과Clinical Trial Published on 2022-02-232022-09-11 Journal: Vaccine [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 AKS-452 Alpha alpha and delta variants anti-SARS-CoV-2 Antigen caused Cell Cohort cohorts cold chain complex conducted coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 Delta variants distribution dose Endpoint Fc-fusion fusion protein healthy human IgG1 Fc IgG titer IgG titers immunogenicity assessments Infection Infectious disease Live virus mutant neutralization potency occurred Open-label pandemic phase Phase I primary endpoints profile Prophylaxis reactogenicity receiving Receptor binding domain respiratory SAE SAEs SARS-CoV-2 SARS-CoV-2 variant SARS-CoV-2 viral infection secondary endpoint Secondary endpoints seroconversion rates severe acute respiratory syndrome Coronavirus single-center Single-dose skewed Spike protein subject subunit Subunit vaccine Support the SARS-CoV-2 vaccination Vaccine vaccine. Viral viral infections viral spike protein virus infection [DOI] 10.1016/j.vaccine.2022.01.043 PMC 바로가기 [Article Type] Clinical Trial
An Evaluation of Serum 25-Hydroxy Vitamin D Levels in Patients with COVID-19 in New York City뉴욕시에서 COVID-19 환자의 혈청 25-하이드록시 비타민 D 수치 평가Observational Study Published on 2022-02-012022-09-11 Journal: Journal of the American Nutrition Association [Category] COVID19(2023년), SARS, 임상, 치료기술, [키워드] 25-hydroxy vitamin D Adult patient Adult patients Affect Cohort cohort study Complication COVID-19 COVID-19 disease COVID-19 patient Cytokine release syndrome Cytokines Deficient Deterioration disease Elevation evaluated highest Hospitalization hydroxy vitamin D illnesses Inflammatory inflammatory. less Level likelihood Mortality mortality rate mortality rates need for oxygen New York City oxygen oxygen support Patient patients with COVID-19 plasma positive primary endpoint primary endpoints pro-inflammatory cytokines proinflammatory cytokines reduce reducing respiratory tract retrospective risk SARS-CoV-2 SARS-CoV-2 test serum Support System tested therapy Vitamin Vitamin D with COVID-19 [DOI] 10.1080/07315724.2020.1869626 PMC 바로가기 [Article Type] Observational Study
Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial보조제 서브유닛 단백질 COVID-19 백신, SCB-2019의 효능: 2상 및 3상 다기관, 이중 맹검, 무작위 배정, 위약 대조 시험Clinical Trial Published on 2022-01-292022-09-11 Journal: Lancet (London, England) [Category] 변종, 임상, [키워드] 1:1 95% CI alum assigned baseline Belgium biopharmaceutical Brazil caused chloride circulating Clover Coalition country COVID 19 COVID-19 COVID-19 case COVID-19 vaccine CpG Cutoff dose doses double-blind effective vaccine Effective vaccines Efficacy efficacy analysis elicited Endpoint enrolled EudraCT exclusion FIVE follow-up period groups Health health condition injection injection site pain intramuscular dose Local median Mild-to-moderate moderate-to-severe COVID-19 MOST multicentre notable Older pandemic participant per-protocol per-protocol population Phase 2 Placebo placebo recipients placebo-controlled trial predominant primary endpoints Protein provide randomisation randomised Randomly receive Registered RT-PCR Safe SAR-CoV-2 SARS CoV SARS-CoV-2 SCB-2019 second dose seronegative participant Seropositivity severe COVID-19 severity Sodium chloride South Africa subset subunit systemic adverse event systemic adverse events Vaccine vaccine efficacy vaccinee vaccinees variant virus virus variants viruses was done [DOI] 10.1016/S0140-6736(22)00055-1 PMC 바로가기 [Article Type] Clinical Trial