Effects of temporarily suspending low-dose methotrexate treatment for 2 weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions: protocol for a multicentre randomised controlled trial and nested mechanistic substudy (Vaccine Response On/Off Methotrexate (VROOM) study)SARS-CoV-2 백신 부스터 후 2주간 저용량 메토트렉세이트 치료를 일시적으로 중단하는 것이 염증성 질환이 있는 면역억제 성인의 백신 반응에 미치는 영향: 다기관 무작위 대조 시험 및 중첩 기전 하위 연구 프로토콜(Vaccine Response On/Off Methotrexate(VROOM) ) 공부하다)Article Published on 2022-05-032022-09-11 Journal: BMJ Open [Category] COVID19(2023년), SARS, 임상, [키워드] 1:1 adjusted Analysis Anti-spike antibody approved Arm ARMS assessment Autoimmune B-cell baseline biochemical booster booster vaccination clinical trials clinics collected conducted conferences COVID-19 Dermatology disease Disease activity domain Effect ENhance Ethics ethics committee evaluate Factor feasibility group Health Research Authority immune response Immunosuppressed IMPROVE Inflammatory inflammatory conditions Intention intention to treat Intervention investigated IRAS low-dose main outcome measure memory methotrexate multicentre neutralising antibody titre Open-label Other parallel group participant Participants Patient peer review performed Pragmatic Primary outcome protocol randomisation randomised randomised controlled randomised controlled trial RBD REC registration number repeated measure repeated measures required Research Ethics response Result rheumatology Sample size SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 vaccine secondary outcome secondary outcome measure subject T-cell Response Treatment Trial UK hospitals usual care vaccination against COVID-19 vaccine response West written Informed Consent [DOI] 10.1136/bmjopen-2022-062599 PMC 바로가기 [Article Type] Article
Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trialCOVID-19(TICO)로 입원한 성인을 위한 두 가지 중화 단일클론항체 치료제인 소트로비맙과 BRII-196과 BRII-198의 효능 및 안전성: 무작위 대조 시험Randomized Controlled Trial Published on 2022-05-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), SARS, 임상, 진단, [키워드] addition adjusted adjusted odds ratio Administered analyses Analysis assigned Biotechnology Clinical outcome clinical recovery clinical trial Complication complications of COVID-19 COVID-19 COVID-19 symptom death defined Denmark died discharge double-blind Efficacy Efficacy and safety eligible enrolled enrolment female hospital hospitalised Inpatient Interim intravenously laboratory-confirmed SARS-CoV-2 infection male matching placebo median age modified intention-to-treat monoclonal antibody neutralising operation Organ failure outcome participant Patient Placebo placebo group placebo-controlled Poland Primary outcome randomisation randomised randomised controlled trial Randomly recruited Registered Serious Adverse Events significantly higher single dose speed Standard of care stratified study drug sustained Switzerland the placebo group Therapeutics Therapies therapy Treatment Trial USA were assessed with COVID-19 [DOI] 10.1016/S1473-3099(21)00751-9 PMC 바로가기 [Article Type] Randomized Controlled Trial
Pharmacological interventions to prevent Covid-19 disease: A rapid reviewCovid-19 질병을 예방하기 위한 약리학적 개입: 신속한 검토Review Published on 2022-05-012022-09-12 Journal: Reviews in Medical Virology [Category] COVID19(2023년), MERS, SARS, 진단, [키워드] article certainty of evidence Combination coronavirus coronavirus disease COVID-19 determine drug intervention Effectiveness high quality evidence high risk incidence Intervention Ivermectin monoclonal antibody peer-reviewed pharmacological intervention Placebo Prevent prevention Prophylaxis protective effect randomised controlled trial RCT RCTs reduce reduced reported risk of bia Risk of bias SARS-CoV-2 SARS-COV-2 infection Severity of disease significantly Support symptomatic and asymptomatic symptomatic disease tested Trial Vaccines Viral load while [DOI] 10.1002/rmv.2299 PMC 바로가기 [Article Type] Review
Antibody response to the COVID-19 ChAdOx1nCov-19 and BNT162b vaccines after temporary suspension of DMARD therapy in immune-mediated inflammatory disease (RESCUE)면역매개염증질환(RESCUE)에서 DMARD 치료를 일시적으로 중단한 후 COVID-19 ChAdOx1nCov-19 및 BNT162b 백신에 대한 항체 반응Randomized Controlled Trial Published on 2022-05-012022-09-11 Journal: RMD Open [Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료기술, 치료제, [키워드] Adult patients Antibody Response Antibody responses antirheumatic agents AstraZeneca AZ vaccine baseline biologic BNT162b Control control group control groups controls COVID-19 csDMARD dose Final first and second dose first dose first vaccination group groups IgG Immune-mediated immunogenicity inflammatory disease Messenger RNA multicentre not significantly different Patient Pfizer Protein randomised randomised controlled trial registration number response S1/S2 SARS-CoV-2 antibody SARS-CoV-2 IgG SARS-CoV2 second dose second vaccination Seroconversion seroconversion rate seroconversion rates significantly lower the antibody response the mean therapy titre titres U/mL vaccination Vaccine were measured [DOI] 10.1136/rmdopen-2022-002301 PMC 바로가기 [Article Type] Randomized Controlled Trial
COVID-19 Pandemic and Exercise (COPE) trial: a multigroup pragmatic randomised controlled trial examining effects of app-based at-home exercise programs on depressive symptomsRandomized Controlled Trial Published on 2022-05-012022-10-05 Journal: British journal of sports medicine [Category] 임상, [키워드] Analysis baseline Canadian COPE COVID-19 COVID-19 pandemic Depression depressive symptom Depressive symptoms Effect effect size exercise four groups General population global public health globe group growth implication IMPROVE intensity mental health not significantly different pandemic participant Participants populations Pragmatic promotion randomisation randomised randomised controlled trial reduce significantly Support Symptom treatment effect were measured yoga [DOI] 10.1136/bjsports-2021-104379 PMC 바로가기 [Article Type] Randomized Controlled Trial
Effects of COVID-19 Mental Health Interventions Among Children, Adolescents, and Adults Not Quarantined or Undergoing Treatment Due to COVID-19 Infection: A Systematic Review of Randomised Controlled TrialsCOVID-19 감염으로 인해 격리되지 않았거나 치료를 받고 있지 않은 아동, 청소년 및 성인 사이의 COVID-19 정신 건강 개입의 영향: 무작위 대조 시험의 체계적인 검토Article Published on 2022-05-012022-09-11 Journal: Canadian journal of psychiatry. Revue canadienne d [Category] 임상, [키워드] 95% CI 95% confidence interval Anxiety Autoimmune base children Controlled controlled trials coronavirus country COVID-19 COVID-19 infection database Depression depressive symptom Depressive symptoms Effect effective eligible English expressive feasible French General population group therapy heterogeneity high risk hospitalised Infection Internet Intervention Living systematic review mental health mental health interventions not significant nous Older participant Participants Population post-intervention Psychological outcomes psychological outcomes. randomised controlled trial reduced reported review risk of bia searched significantly SMD standardized mean difference Support Swedish Symptom tested the United State therapy Treatment Trial trials United States Worry [DOI] 10.1177/07067437211070648 PMC 바로가기 [Article Type] Article
A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc) Research Published on 2022-04-282022-10-05 Journal: Nature Communications [Category] 임상, [키워드] Analysis Anxiety Attitude avoidance Awareness baseline blinded changes in cognitive conducted Depression diabete difference distress effective emotional Estimated Health Hypothesis Impaired insulin Measures outcome positive Primary outcome randomised randomised controlled trial rate ratio recall reduced reducing restoration risk secondary self-care significantly T1D Treatment Trial Two-arm [DOI] 10.1038/s41467-022-29488-x [Article Type] Research
Conducting a randomised controlled trial of a psychosocial intervention for adolescents with type 1 diabetes during COVID-19: recommendations to overcome the challenges complicated by inconsistent public health guidelines on researchRandomized Controlled Trial Published on 2022-04-272022-10-05 Journal: Trials [Category] 임상, [키워드] amplified approach clinics Conducting COVID-19 COVID-19 pandemic diabete effective Guidance hospital management hospitals include Interpretation Intervention Ireland management mechanism overcome pandemic patients physical contact Psychosocial Psychosocial intervention public health Randomised control trial randomised controlled trial RCT RCTs recommendation recruitment Research researcher Trial Trial management [DOI] 10.1186/s13063-022-06314-9 PMC 바로가기 [Article Type] Randomized Controlled Trial
Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trialRandomized Controlled Trial Published on 2022-04-272022-10-04 Journal: Trials [Category] 임상, [키워드] 7-point ordinal scale adaptive Adaptive sample size addition Analysis analysis plan angiotensin angiotensin receptor blocker Angiotensin receptor blockers Bayesian Bayesian design benefit blocker CLARITY clinical clinical status clinical trial Controlled coronavirus COVID-19 determine disease Effectiveness Evidence India intention-to-treat principle lung failure patients with COVID-19 Placebo primary analysis Primary outcome protocol randomised controlled randomised controlled trial receptor reducing registry Sample size severity standard care Statistical analysis plan Statistical analysis plan. the WHO Treatment effectiveness Trial Two-arm was selected [DOI] 10.1186/s13063-022-06167-2 PMC 바로가기 [Article Type] Randomized Controlled Trial
Comparison of standard prophylactic, intermediate prophylactic and therapeutic anticoagulation in patients with severe COVID-19: protocol for the ANTICOVID multicentre, parallel-group, open-label, randomised controlled trial중증 COVID-19 환자에 대한 표준 예방, 중간 예방 및 치료 항응고 요법의 비교: ANTICOVID 다기관, 병렬 그룹, 공개 라벨, 무작위 대조 시험에 대한 프로토콜Article Published on 2022-04-262022-09-11 Journal: BMJ Open [Category] 임상, [키워드] absence all-cause mortality anticoagulation approved bleeding body mass body mass index Clinical improvement Clinical practice clinical scale Coagulopathy component Computed tomography COVID-19 criterion D-dimer D-dimer level D-dimer levels death defined dysfunction Efficacy and safety ethical committee Ethics ethics committee Evolution extension extreme followed by France French Hierarchical High-dose Hospital stay Ile include induce intensive care intensive care unit Invasive mechanical ventilation life low-dose lung major bleeding event Microvascular thrombosis multicentre Multiorgan Open-label outcome oxygen parallel-group Paris pathophysiological Patient patients patients with COVID-19 peer-reviewed primary endpoint Prophylactic protocol pulmonary artery Quality of life randomisation randomised randomised controlled randomised controlled trial randomised trials receive recruit registration number renal renal failure respiratory respiratory infections secondary Secondary outcomes Sepsis sepsis-induced coagulopathy severe COVID-19 stratified submitted the primary endpoint therapeutic anticoagulation Thromboembolism thrombosis thrombotic Trial trials Vasopressor venous ventilator weight [DOI] 10.1136/bmjopen-2021-059383 PMC 바로가기 [Article Type] Article