Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trialCOVID-19 전염병 동안 가정 감염 통제를 개선하기 위한 디지털 행동 변화 개입인 Germ Defence의 1차 진료 구현: 무작위 통제 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-04-092022-09-10 Journal: Trials [Category] MERS, 임상, [키워드] 1:1 antibiotic Behaviour change blinded Blinding block blocks Bristol Care clinical Cluster collaboration Commission comparator Contact Controlled trial coronavirus COVID-19 COVID-19 symptom detect diagnose Digital health Digital medicine dissemination Effect effect size Effectiveness element engage England enrolment Gastrointestinal infection gastrointestinal infections general practices Germ group hand washing help Hospital admission hygiene identity implementation IMPROVE incidence incidence of COVID-19 include independent individual Infection infection control Infectious disease Intervention intervention arm involved ISRCTN ISRCTN registry management measure number objective outcome overcome participant Patient personalised Prevalence primary care Primary outcome Principal Investigators problem problem solving protection protocol randomisation randomised randomised controlled trial Randomly receive reduce Registered respiratory respiratory tract infection Sample size secondary outcome Secondary outcomes Spread Stata Statistical Software statistical statistician Study protocol supplementary material Symptom Trial Trial registration Two-arm usual care website [DOI] 10.1186/s13063-021-05188-7 PMC 바로가기 [Article Type] Letter
CoCo20 protocol: a pilot longitudinal follow-up study about the psychiatric outcomes in a paediatric population and their families during and after the stay-at-home related to coronavirus pandemic (COVID-19)Article Published on 2021-04-082022-10-05 Journal: BMJ Open [Category] SARS, 임상, [키워드] adolescent psychiatry Anxiety anxiety disorders approved assessment baseline characterisation child & children coronavirus COVID-19 COVID-19 pandemic disorder enrolled enrolment Ethics ethics committee Evidence FIVE follow-up study hyperactivity Inclusion Infant International Measures mental health methodology multicentre National offer outcome Outpatient pandemic Patient Post-traumatic stress disorder Preschool protocol Psychiatric psychiatric assessment psychiatric disorder Psychiatric disorders Psychological distress PTSD public health reported risk schedule significant increase Stress Symptom university Version viral outbreak [DOI] 10.1136/bmjopen-2020-044667 PMC 바로가기 [Article Type] Article
Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trialCOVID-19(FLARE) 외래 환자의 조기 항바이러스 치료: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-03-082022-09-01 Journal: Trials [Category] SARS, 임상, 진단, 치료기술, 치료제, [키워드] 24 hours 48 hour 48 hours absence admitted to ICU aetiology age ALT Analysis Anosmia anticipated antiviral therapy Antiviral treatment antivirals Appendix Arm arrhythmia AST Asthma Asymptomatic Autoimmune blinded to treatment Blinding blood sample BMI Breastfeeding childbearing potential Cholangitis chronic chronic hepatitis Chronic kidney disease chronic liver disease chronic respiratory disease cirrhosis clinical condition collected combination therapy Comorbidity concealed Concomitant concomitant medications conducted COPD coryza cough COVID-19 COVID-19 disease COVID-19 vaccine criteria current Date Day decrease defined Deleterious detectable diabetes died disease dissemination dose double-blind Duration early treatment effective EGFR element enrolled enrolment Ethnicity examined exclusion criteria factorial design Favipiravir female female participant Fever followed by Free Gender headache heart disease Hepatitis hepatotoxicity HIV infection hospital hospitalisation hypersensitivity hypertension in viral include inclusion criteria ingredient investigator investigators Ischaemic heart disease Kidney disease liver Liver disease London Lopinavir Lopinavir/ritonavir malaise male participant male participants measure medication Mutation myalgia Myocardial infarction no symptom non-hospitalised not limited number obesity objective observational studies observational study oral outcome Outpatient outpatients participant Participants partner percentage pharmacokinetic phase IIa Placebo placebo-controlled placebo-controlled trial positive presence or absence Primary outcome Proportion of participant Protease inhibitor protocol randomised randomised controlled trial Rate Registered Registration respiratory Respiratory disease risk Ritonavir Safety Saliva saliva samples Sample size SARS-CoV-2 secondary Secondary outcomes Shortness of breath smoker smoking smoking status Stage status steatohepatitis Stool Study protocol supplementary material Symptom symptom onset symptomatic tested therapy Toxicity Treatment treatment allocation Trial trial medication Trial registration undetectable United Kingdom upper respiratory tract vaccine trial valvular valvular heart disease Viral Viral load website with COVID-19 [DOI] 10.1186/s13063-021-05139-2 PMC 바로가기 [Article Type] Letter
Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trialARDS 및 COVID-19 환자에서 덱사메타손의 효과 – 전향적, 다기관, 공개 라벨, 병렬 그룹, 무작위 대조 시험(REMED 시험): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-03-012022-09-10 Journal: Trials [Category] SARS, 임상, 치료기술, [키워드] (C-reactive protein 24 hour 24 hours administration adrenal gland Adult patients Adverse adverse events age alcohol allergy allocation Antigen ARDS ARDS patients ARMS assumed Barthel Index benzyl alcohol Berlin Berlin criteria Blinding Block randomisation Brazil Breastfeeding C-reactive protein calculated can be used Cardiac arrest Care carried case report form CCI Charlson Comorbidity Index Chemotherapy clinical Comorbidity comparator completion condition conducted consequence Contraception control group Corticosteroid Corticosteroids COVID-19 COVID-19 ARDS patient criteria CRP current Czech Republic Day decision defined detect Dexamethasone dexamethasone 6 mg diagnosed dissemination dose doses Dynamics eCRF Effect Effectiveness Efficacy and safety electronic case report form element eligible Endpoint enrolled enrolment EudraCT evaluate event expected exploratory Factor followed by French gastrointestinal bleeding HFNC hospital hospital discharge Hospital stay hypersensitivity Hypothesis ICU ICU admission ICUs Identifier Immunosuppression immunosuppressive drug immunosuppressive drugs Independence independent independent of Infection infections Inflammatory infusion intensive care unit intensive care units Intervention intervention group intractable intravenously intubate intubation investigational medicinal product investigator investigators Laboratory life malignancy marker mechanical ventilation medical history moderate moderate to severe Mortality nasal nasal cannula number objective observational study once daily Open-label open-label trial outcome oxygen Oxygen therapy PaO parallel-group participant Participation Patient patients with ARDS patients with moderate performed power power of 80% Pragmatic Pregnancy present primary efficacy endpoint primary endpoint protocol Quality of life randomisation randomised randomised controlled trial receive recruitment Registered routine clinical practice RT-PCR Sample size scale secondary Secondary endpoints Septic shock sequence severe ARDS sexual abstinence solution Standard deviation statistical analysis statistician status Stratification stratified Study protocol superinfection supplementary material systemic systemic corticosteroids thrombotic Thrombotic complications title Treatment treatment arm Trial Trial registration two-sided type I type I error university hospital Ventilation ventilator-free day Ventilator-free days Version VFD website WHO [DOI] 10.1186/s13063-021-05116-9 PMC 바로가기 [Article Type] Letter
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in RussiarAd26 및 rAd5 벡터 기반 이종 프라임-부스트 COVID-19 백신의 안전성 및 효능: 러시아의 무작위 대조 3상 시험 중간 분석Clinical Trial Published on 2021-02-202022-09-12 Journal: Lancet (London, England) [Category] Fulltext, MERS, 임상, 진단, [키워드] 95% CI Administered adverse event age Analysis assigned available data case report form Cellular immune response city clinical trials COVID-19 database death Department Direct dose double-blind Efficacy Efficacy and safety enrolment events excluded first dose full-length SARS-CoV-2 Gam-COVID-Vac glycoprotein Heterologous heterologous prime-boost hospital humoral IgG and IgM independent Infectious disease interim analysis intramuscularly Investment large cohort MOST participant Participants PCR-confirmed COVID-19 phase 3 trial Placebo placebo-controlled Primary outcome primary outcome analysis proportion protocol randomised randomised controlled Randomly receive receiving recombinant adenovirus Registered reported Russia Safety safety profile SARS-CoV-2 PCR second dose Serious Adverse Event Stratification the placebo group the vaccine Trial vaccination Vaccine vector were assessed [DOI] 10.1016/S0140-6736(21)00234-8 PMC 바로가기 [Article Type] Clinical Trial
Serum KL-6 Could Represent a Reliable Indicator of Unfavourable Outcome in Patients with COVID-19 Pneumonia혈청 KL-6은 COVID-19 폐렴 환자에서 불리한 결과의 신뢰할 수 있는 지표를 나타낼 수 있습니다Article Published on 2021-02-202022-08-31 Journal: International Journal of Environmental Research an [Category] MERS, 바이오마커, [키워드] Accuracy antibody Antigen blood sample Blood samples chemiluminescence collected Concentration COVID-19 COVID-19 pneumonia cut-off value death died elevated enrolled enrolment enzyme enzyme immunoassay evaluated Fujirebio IL-6 immunoassay Indicator Interstitial lung diseases interstitial pneumonia KL-6 Lung diseases median Mortality outcome P/F ratio parameter Patient patients with COVID-19 Pneumonia Positive predictive value Predictive value prognostic Pulmonary function Respiratory failure risk SARS-CoV-2 SARS-CoV2 infection serum severe respiratory failure significantly lower those who survived U/mL were measured with COVID-19 [DOI] 10.3390/ijerph18042078 PMC 바로가기 [Article Type] Article
COVID-19 mortality in the UK Biobank cohort: revisiting and evaluating risk factorsCovid-19 Published on 2021-02-152022-10-31 Journal: European Journal of Epidemiology [Category] COVID-19, MERS, SARS, [키워드] association Autoimmune disease black body mass index cardiovascular disease characterisation characteristic Cohort Comorbidities Comorbidity contributed contributing to covariates COVID-19 COVID-19 mortality death diabetes employment enrolment explained Factors healthcare worker hypertension increased risk inhibitor investigated lipids Male sex medications Mortality MOST multivariable Non-COVID-19 oral steroid prospective cohort Regression model regression models reported risk risk factor SARS-CoV-2 selected smoker smoking supplementary material UK biobank white with COVID-19 [DOI] 10.1007/s10654-021-00722-y PMC 바로가기 [Article Type] Covid-19
A double blinded placebo controlled comparative clinical trial to evaluate the effectiveness of Siddha medicines, Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy treatment in the management of symptomatic COVID 19 patients – a structured summary of a study protocol for a randomized controlled trial증상이 있는 COVID 19 환자의 관리에서 표준 동종 요법 치료와 함께 Siddha 의약품, Kaba Sura Kudineer(KSK) 및 Nilavembu Kudineer(NVK)의 효과를 평가하기 위한 이중 맹검 위약 대조 비교 임상 시험 - 에 대한 연구 프로토콜의 구조화된 요약 무작위 대조 시험Letter Published on 2021-02-112022-09-10 Journal: Trials [Category] MERS, 임상, [키워드] acute respiratory distress syndrome addition Adverse adverse events age age and sex appearance Arm Asymptomatic Bacterial biochemical markers blinded block calculated CAM change Chemical clinical clinical symptom Clinical symptoms clinical trial Complication complications Controlled count COVID COVID 19 COVID 19 patient CRP Ct value CTRI D-dimer Data analysis Date determine diagnose dimer dissemination drug Effect Effectiveness element eligibility eliminated enrolment evaluate exploratory ferritin food GMP group Herbal Hospital stay IL 6 IL6 incidence India Infection infiltration Inflammatory marker inflammatory markers Informed consent investigators involved Laboratory LDH literature management marker Medical Sciences Medicine Medicines Microsoft Excel moderate symptom moderate symptoms morning Night number objective outcome participant Patient patients PCR Placebo Pneumonia profile protocol randomised controlled trial randomization Randomized Randomized controlled trial Ratio recruited recruitment reduce reduction Registered Registration registry reported respiratory respiratory distress Respiratory distress syndrome risk Sample Sample size SARS-CoV-2 secondary Secondary objectives Secondary outcomes severe COVID-19 symptoms Siddha Siddha Medicine smoking SPIRIT guidelines statistician status Study protocol submission Sura symptomatic Taste tea the disease time Total Treatment Trial trial protocol Trial registration value Viral Viral load Viral pneumonia website were blinded [DOI] 10.1186/s13063-021-05041-x PMC 바로가기 [Article Type] Letter
Adjunctive IgM-enriched immunoglobulin therapy with a personalised dose based on serum IgM-titres versus standard dose in the treatment of septic shock: a randomised controlled trial (IgM-fat trial)패혈성 쇼크 치료에서 혈청 IgM 역가 대 표준 용량을 기반으로 한 개인 맞춤 용량을 사용한 보조 IgM 강화 면역글로불린 요법: 무작위 대조 시험(IgM 지방 시험)Randomized Controlled Trial Published on 2021-02-112022-09-12 Journal: BMJ Open [Category] MERS, 임상, 진단, [키워드] 1:1 all-cause mortality approved Area assigned Biomarkers circulating Clinical outcome Clinical severity Committee Critical care daily dose dosage dose effective enrolled enrolment Ethics EudraCT Host immune response hypothesised IgM Immunoglobulin immunology Infection Infectious diseases information Intensive intensive & intensive care unit Intravenous immunoglobulin investigator Italian Mortality multicentre Patient per day personalised polyclonal primary endpoint randomised randomised controlled trial Randomly receive Registered Sepsis Septic shock serum Standard dose standard treatment Study protocol the ethics committee therapy threshold titre Treatment Trial trial protocol vasoactive drug [DOI] 10.1136/bmjopen-2019-036616 PMC 바로가기 [Article Type] Randomized Controlled Trial
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 trial코로나바이러스 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 요약Study 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