Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials성인에서 COVID-19에 대한 재조합 직렬 반복 이량체 RBD 기반 단백질 서브유닛 백신(ZF2001)의 안전성 및 면역원성: 2건의 무작위 배정, 이중 맹검, 위약 대조, 1상 및 2상 시험Clinical Trial Published on 2021-08-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] MERS, SARS, 임상, 진단, [키워드] 95% CI Abstract Academy adverse event age allergy antibodies Antigen appear assigned Beijing biopharmaceutical center China Chinese Chongqing Contact Control COVID-19 COVID-19 cases COVID-19 vaccine determine development dimeric dose double-blind drug Efficacy eligible enrolled enrolment FIVE Follow-up geometric mean titre GMT group help immunogenic immunogenicity data intention-to-treat intramuscularly Laboratory magnitude Major material mechanism Mild moderate neutralising antibody Occurrence participant Participants per-protocol Phase 1 phase 1 trial phase 2 trial phase 3 trial Placebo placebo group placebo-controlled prevention Primary outcome priority Program protein subunit vaccine randomised Randomly RBD RBD-based protein subunit receive Registered reported Safety SARS-CoV SARS-CoV-2 SARS-COV-2 infection Science second dose Serious Adverse Event Serious Adverse Events seroconversion rate Seven Spike protein Spread Support technology the placebo group the receptor-binding domain the SARS-CoV-2 the vaccine translation Trial trials university hospital vaccination Vaccine vaccine group Vaccines was done ZF2001 [DOI] 10.1016/S1473-3099(21)00127-4 PMC 바로가기 [Article Type] Clinical Trial
Cohort profile: A Prospective Household cohort study of Influenza, Respiratory syncytial virus and other respiratory pathogens community burden and Transmission dynamics in South Africa, 2016–2018Original Article Published on 2021-07-232022-10-30 Journal: Influenza and Other Respiratory Viruses [Category] Coronavirus, MERS, SARS, [키워드] Analysis asymptomatic infection burden Cohort Cohort profile cohort study collected Community Date eligible enrolled enrolment finding for inclusion fraction Frequency Future household household contact household transmission incidence include index case individual Infection Influenza Influenza virus initiated Nasopharyngeal swab nasopharyngeal swabs over participant PCR plan polymerase chain positive Prospective Randomly respiratory respiratory pathogen respiratory syncytial virus RSV SARS‐CoV‐2 SARS‐CoV‐2 infection selected serology South Africa symptomatic tested Transmission virus virus transmission [DOI] 10.1111/irv.12881 PMC 바로가기 [Article Type] Original Article
PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19PEP-CoV 프로토콜: 초기 COVID-19에서 호흡기 악화 및 입원을 예방하기 위한 PEP 플루트 자가 관리 무작위 대조 시험Article Published on 2021-06-302022-09-11 Journal: BMJ Open [Category] SARS, 임상, [키워드] activities activity assessment Chest chest tightness chronic pulmonary disease clinical trials cohort of patient collapse Contact control arm COPD cough Course COVID-19 COVID-19 symptoms daily living Deterioration disease Dyspnoea Effectiveness enrolment Ethical approval Ethics expiratory Expiratory Pressure Follow-up Health Healthcare systems high mortality rate hospital Hospital admission hospitalisation hypothesise individual Infectious diseases Intervention intervention group journal Local measure non-hospitalised Nurse offer pandemic participant Patient phlegm Pneumonia Prevent Preventive medicine Primary outcome Prognosis public health pulmonary disease randomised controlled trial Randomised trial receive recruit Registered registration number Research Ethics Research Ethics Committee respiratory medicine (see thoracic medicine) respiratory symptom respiratory symptoms Result Safe SARS-CoV-2 SARS-COV-2 infection secondary outcome self-care severe pulmonary disease shown sleep quality susceptibility symptom severity Symptoms Test Thoracic Treatment Trial usual care [DOI] 10.1136/bmjopen-2021-050582 PMC 바로가기 [Article Type] Article
Sleep Apnea and Fetal Growth Restriction (SAFER) study: protocol for a pragmatic randomised clinical trial of positive airway pressure as an antenatal therapy for fetal growth restriction in maternal obstructive sleep apnoea수면 무호흡증 및 태아 성장 제한(SAFER) 연구: 산모 폐쇄성 수면 무호흡증의 태아 성장 제한에 대한 산전 요법으로서 기도 양압에 대한 실용적인 무작위 임상 시험 프로토콜Article Published on 2021-06-292022-09-11 Journal: BMJ Open [Category] SARS, 임상, [키워드] Admission age Anomaly Antenatal APGAR score approved Birth weight Care cause center clinical trial complications Controlled trial COVID-19 Desaturation enrolment Ethics fetal FGR gestation gestational age growth hypothesise IMPROVE include institutional review board institutional review boards intensive care intention-to-treat analysis intrauterine infection Jerusalem maternal medicine morbidity and mortality mother multicentre Neonatal neonatal intensive care unit New York Obstructive obstructive sleep apnoea OSA outcome outcomes oxygen participant perinatology positive airway pressure Pragmatic pregnancies Pregnancy pregnant women Primary outcome proceed protocol questionnaire randomised registration number restriction risk risk factor screened second trimester secondary outcome Secondary outcomes Sleep sleep apnea sleep apnoea Sleep medicine Stage stage 2 standard care Stillbirth therapy Treatment Ultrasound undergo university Washington [DOI] 10.1136/bmjopen-2021-049120 PMC 바로가기 [Article Type] Article
Effect of Tenofovir Disoproxil Fumarate and Emtricitabine on nasopharyngeal SARS-CoV-2 viral load burden amongst outpatients with COVID-19: A pilot, randomized, open-label phase 2 trialResearch Paper Published on 2021-06-272022-10-04 Journal: EClinicalMedicine [Category] 신약개발, 임상, [키워드] 1:1 95% CI 95% confidence interval accelerate Adverse adverse events assigned baseline clearance Cohort collected conducted COVID-19 COVID-related symptoms cycle threshold develop died drug discontinuation early treatment Effect emtricitabine Endpoint enrolled enrolment event finding France fumarate funding gastrointestinal side effect hospital hospitalisation in both groups Inclusion increase in Infection interfere IQR less median nasopharyngeal Nasopharyngeal swab Open-label Other Outpatient Patient per day phase 2 trial pilot study Randomized Randomly RdRP receive Registered reported RNA polymerase RT-PCR SARS CoV-2 SARS-COV-2 infection SARS-CoV-2 viral SARS-CoV-2 viral load secondary endpoint severe COVID-19 Standard of care Support symptom onset tenofovir therapy Time to recovery treated treatment group Trial viral burden [DOI] 10.1016/j.eclinm.2021.100993 PMC 바로가기 [Article Type] Research Paper
A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trialSARS-COV-2 감염 (COVID-RED)의 원격 조기 발견을위한 일일 증상 일기 외에 웨어러블 장치의 효과를 조사하기위한 전향 적, 무작위, 단일 맹장, 크로스 오버 시험 : 연구의 구조적 요약.무작위 제어 시험을위한 프로토콜Letter Published on 2021-06-222022-09-01 Journal: Trials [Category] MERS, SARS, 임상, 진단, 치료기술, 치료제, [키워드] 1:1 24 hours addition adhere Algorithm Algorithms all subject all subjects analysed antibody Antibody testing antibody tests Antigen antigen tests Appointment approach asked assigned Asymptomatic asymptomatic individual asymptomatic infection average baseline blinded Blinding Bracelet can not capillary blood Chain Reaction changes in Characteristics cholinergic urticaria Cohort collected Complete conditions conducted consent form contribute control condition COVID-19 COVID-19 infection COVID-19 vaccination current Daily demographics described detect determine develop deviation diary dissemination Early detection element eligibility criteria eligible End enrolled enrolment evaluate exclusion criteria feedback Follow-up followed by gold gold standard Health health resource heart rate incidence rates Inclusion inclusion criteria individual individuals infected individual infected individuals infected with SARS-CoV-2 Infection information Informed consent informed consent form initial involved Laboratory laboratory-confirmed SARS-CoV-2 infection learning machine learning management media medical history Mobile application Month must nasal swab National natural infection Negative predictive value Netherland Netherlands notification NPV number objective occur outcome pacemaker parameter participant Participants PCR PCR test PCR tests Period phase physiological physiological parameters polymerase chain polymerase chain reaction populations portal positive Positive predictive value possession PPV pre-symptomatic Predictive value primary analysis profession proportion Prospective protocol provided Pulse rate questionnaire randomisation randomised randomised controlled trial randomization sequence Randomized Randomized controlled trial Randomly receive recommendation recruited recruitment reduce Registered reported resident resource responsible resulting risk Sample size SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 infections SARS-CoV-2 test SARS-CoV-2 virus secondary outcome sensitivity sequence sequences serology serology test serology tests significantly skin temperature Smartphone social media specificity staff status stratified stratified block randomization study participation Study protocol subject suffering supplementary material Symptom Symptom diary Symptoms target temperature test result tested the SARS-CoV-2 thought Transmission transmissions Trial Trial registration undergo urticaria used to evaluate user vaccinated against COVID-19 vaccination Vaccine Variability wearable device website Well-being [DOI] 10.1186/s13063-021-05241-5 PMC 바로가기 [Article Type] Letter
TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in BrazilTELE-critical Care 대 일반 Care On ICU 성과(TELESCOPE): 브라질의 성인 일반 ICU에 대한 클러스터 무작위 임상 시험 프로토콜Article Published on 2021-06-212022-09-11 Journal: BMJ Open [Category] 임상, [키워드] 24 hour 24 hours Analysis approved Brazil Care carried classification clinical trial composed conferences control group coordinator criteria Critical Critical care Daily defined dissemination enrolled enrolment enteral feeding Ethics evaluate exclusion criteria Health Health care hospital Hospital mortality ICU ICUs incidence include inclusion criteria infections institutional review board Intensive intensive & intensive care intensive care unit Intervention IRB IRBs joint Local minimum Mortality mortality rate multicentre outcome Patient peer-reviewed Primary outcome profile profiles protocol quality in health care randomised receiving reduce registration number resource Result secondary Secondary outcomes Sedation Study protocol submission supported Telemedicine therapeutic Trial unit usual care ventilator-free day Ventilator-free days [DOI] 10.1136/bmjopen-2020-042302 PMC 바로가기 [Article Type] Article
Assessing the efficacy and safety of hydroxychloroquine as outpatient treatment of COVID-19: a randomized controlled trialCOVID-19의 외래 환자 치료로서 하이드록시클로로퀸의 효능 및 안전성 평가: 무작위 대조 시험Randomized Controlled Trial Published on 2021-06-182022-09-11 Journal: CMAJ open [Category] SARS, 임상, 치료제, [키워드] 95% confidence interval Assessing assigned Chain Reaction Community Composite conducted Contact contact with Controlled trial COVID-19 COVID-19 pandemic death determine determined by did not reduce direct contact disposition effect of treatment Efficacy and safety eligible enrolment Evidence expected First wave Follow-up hazard ratio Hospitalization hospitalizations hospitalized patient hospitalized patients Hydroxychloroquine hydroxychloroquine group hydroxychloroquine treatment identification individual Invasive mechanical ventilation matching placebo mechanical ventilation Mortality outcome outcomes Outpatient outpatients participant Participants patients PCR test Placebo placebo group polymerase chain polymerase chain reaction positive RT-PCR Prevent prevented Primary outcome priority raised Randomized controlled trial Randomly reduced resulting reverse transcription reverse transcription polymerase chain reaction Ribonucleic acid RT-PCR Safety SARS-COV-2 infection secondary Secondary outcomes Serious Adverse Event Serious Adverse Events severe COVID-19 study drug survived symptom duration symptom onset the placebo group therapy Treatment Trial viral ribonucleic acid with COVID-19 [DOI] 10.9778/cmajo.20210069 PMC 바로가기 [Article Type] Randomized Controlled Trial
Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trialHIV 감염에서 SARS-COV-2에 대한 Chadox1 NCOV-19 (AZD1222) 백신의 안전성 및 면역 원성 : 2/3 상 임상 시험의 단일 암 보체.Clinical Trial Published on 2021-06-182022-08-13 Journal: The Lancet. HIV [Category] MERS, SARS, 임상, 진단, [키워드] ACHE age All participants analysed analyses anti-Spike IgG anti-spike IgG response Anti-spike IgG responses antibody Antiretroviral therapy ART AstraZeneca available data AZD1222 CD4 CD4 cell CD4 count CD4 counts Cell cell-mediated immune response Cell-mediated immune responses cellular response Cellular responses ChAdOx1 ChAdOx1 nCoV-19 chill chills Clinical research clinical trial Coalition Comorbidity determined by dose Eligible participants ELISA ELISPOT enrolled enrolment enzyme enzyme-linked immunospot assay fatigue finding FIVE frequencies Frequency functional funding General population headache HIV HIV clinics HIV-negative HIV-uninfected humoral Humoral response humoral responses IFN-γ IgG response IgG responses immune responses Immunity immunogenic immunogenicity injection injection site Innovation IQR joint joint pain less Live virus Local London magnitude malaise male median median age muscle ache nausea network neutralisation NIHR NIHR Oxford Biomedical Research Centre no correlation no difference occurred Open-label outcome Oxford Pain participant Participants peaked people with HIV persistence phase 2/3 phase 2/3 trial plasma Primary outcome Primary outcomes prime-boost regimen proliferation proliferative protocol reactogenicity Registered reported required response Safe Safety SARS-CoV-2 SARS-CoV-2 spike-specific Serious Adverse Event Serious Adverse Events single-arm South sustained systemic reaction systemic reactions T-cell the vaccine undetectable vaccination Vaccine vaccine immunogenicity Valley Viral Viral load were measured with HIV [DOI] 10.1016/S2352-3018(21)00103-X PMC 바로가기 [Article Type] Clinical Trial
Early COVID-19 pandemic’s toll on tuberculosis services, WHO European Region, January to June 20202020년 1월부터 6월까지 WHO 유럽 지역 결핵 서비스에 대한 초기 COVID-19 대유행의 피해Research Published on 2021-06-172022-09-10 Journal: Eurosurveillance [Category] MERS, SARS, 치료기술, 치료제, [키워드] affected asked average country COVID-19 COVID-19 pandemic decrease Diagnosis drug-resistant tuberculosis enrolled enrolment equipment Essential European Health Organization Health services highest implementation Increases increases in introduced measure member pandemic Patient public health public health and social measures Quantitative data quarter Region reported resources Result rifampicin SARS-CoV-2 severity Severity Score state Sustainable Development Goals target targeted intervention targeted interventions Treatment Tuberculosis WHO World Health Organization [DOI] 10.2807/1560-7917.ES.2021.26.24.2100231 PMC 바로가기 [Article Type] Research