enrolment – Page 11 – Communicable Diseases Research

Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol

노출된 가구 접촉에서 COVID-19 전파를 제거하기 위한 프로바이오틱스의 무작위, 이중 맹검, 위약 대조 시험(PROTECT-EHC): 임상 시험 프로토콜

Article

Published on 2021-05-052022-09-11
Journal: BMJ Open [Category] SARS, 임상,

Seroprevalence of SARS-CoV2 in IBD Patients Treated with Biologic Therapy

생물학적 치료를 받은 IBD 환자에서 SARS-CoV2의 혈청유병률

Observational Study

Published on 2021-05-042022-09-12
Journal: Journal of Crohn's & colitis [Category] SARS, 임상, 진단,

A call to caution when hydroxychloroquine is given to elderly patients with COVID-19

Randomized Controlled Trial

Published on 2021-05-012022-10-05
Journal: International Journal of Infectious Diseases [Category] SARS, 신약개발, 임상,

[키워드] addition Administered administration of hydroxychloroquine Adverse adverse effects age caused clinical trial clinical trials co-medication co-morbidity contraindications contributing to coronavirus disease COVID-19 detrimental diabete disease double-blind drug Elderly patient eligible enrolment extreme for inclusion health condition heart failure hospitalized patient Hydroxychloroquine Interaction interquartile range involved majority Patient patients with COVID-19 placebo-controlled Randomized renal retrospective risk Safe SARS-CoV-2 severe COVID-19 Treatment treatment effects Trial use of hydroxychloroquine widespread with COVID-19
[DOI] 10.1016/j.ijid.2021.04.009 PMC 바로가기 [Article Type] Randomized Controlled Trial

Clinical research activities during COVID-19: the point of view of a promoter of academic clinical trials

Commentary

Published on 2021-04-302022-10-28
Journal: BMC Medical Research Methodology [Category] Coronavirus, Fulltext, MERS, SARS,

Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial

COVID-19 환자를 위한 천연 탄닌 추출물 보충제(TanCOVID): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-282022-09-10
Journal: Trials [Category] MERS, SARS, 임상,

[키워드] 1:1 24 hour 24 hours addition Administered administration affected age All trial participants all-cause mortality Alpha alpha error Antibiotic therapy antipyretics assigned assisted ventilation Azithromycin B12 blinded Blinding branch Buenos Aire Buenos Aires can not Chestnut tannins Clinical symptoms clinical trial closure cognitive computer-generated random numbering conditions Consent control group COVID-19 COVID-19 patient criteria cytokine Cytokines Day Decline decrease defined Definition Department described diagnosis of SARS-CoV-2 dietary supplement difference disease dissemination dose double-blind Efficacy element eligibility eligible enrolled Enrollment enrolment epidemiological evaluate excluded fecal Final first dose first visit Gender gut microbiota Hospital de Clínica Hospital de Clínicas Hospital de Clinicas Jose de San Martin hospital discharge Hydroxychloroquine hypersensitivity ICU impaired consciousness increase in indicated Infection Infectious disease Infectious diseases Inflammation inflammatory mediator Inflammatory mediators Informed consent intestinal intestinal permeability invasive ventilation lactating Level Lopinavir mean difference measure mechanical ventilation mediators microbiota modifications molecular natural non-invasive ventilation number objective Older outcome parallel-group parameter participant Participation Patient patients per day Placebo placebo-controlled platform Potential power power of 80% protocol Quebracho tannins randomization Randomized Randomized controlled trial Randomly Real-time PCR receive recruited recruitment Registered Research Ritonavir Sample size SARS-COV-2 infection SARS-CoV2 screened secondary secondary outcome measures severity Standard therapy standard treatment status study participant Study protocol study randomization submitted supplementary material supply tannin tannins therapy time Time frame took place Treatment treatment allocation Trial trial participant Trial registration undergo university Ventilation website
[DOI] 10.1186/s13063-021-05281-x PMC 바로가기 [Article Type] Letter

Efficacy and safety of nelfinavir in asymptomatic and mild COVID-19 patients: a structured summary of a study protocol for a multicenter, randomized controlled trial

무증상 및 경증 COVID-19 환자에 대한 nelfinavir의 효능 및 안전성: 다기관, 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-282022-09-10
Journal: Trials [Category] SARS, 임상, 치료기술,

[키워드] 1:1 Administered administration adverse event adverse events age all-cause mortality ALT Analysis anticipated Antigen antiviral efficacy AST Asymptomatic asymptomatic patients blinded blinded outcome assessment Blinding blood glucose body temperature both group both groups capture caused childbearing potential clearance clinical Clinical efficacy clinical examinations Clinical symptoms clinical trial clinical trials comparator Patients condition Consent contraceptive method Controlled clinical trial cough COVID-19 creatinine creatinine clearance dataset Day defervescence diabete diabetes diarrhea discretion dissemination distribution drug element enrolled enrolment evaluate event exclusion criteria exploratory Factor female patient Fever Frequency Glucose group hazard ratio Hemophiliac Hemorrhagic history HIV infection hospital hypersensitivity incidence incidence rate Inclusion inclusion and exclusion criteria inclusion criteria Infection Informed consent initial investigator investigator-initiated investigators Japan Japanese LAMP limit log-rank test male Mild mild COVID-19 patient Mild disease mixed-effects model multicenter Nasopharyngeal swab Negative conversion Negative PCR nelfinavir null hypothesis number objective Open-label outcome oxygen Oxygen administration p value parallel group parameter participant Patient patients with asymptomatic PCR PCR test Pneumonia power Pregnancy primary endpoint Primary outcome principal investigator Probability probability distribution protocol random randomization Randomized Randomized controlled trial Registered registry reported required respiratory tract rifampicin room air safety endpoint Saliva saliva samples Sample size SARS-CoV-2 SARS-CoV-2 vaccination secondary efficacy endpoint serious complication serum creatinine severity specimen Standard status study period Study protocol supplementary material survival survival function Symptom symptomatic symptomatic COVID-19 Symptomatic treatment the log-rank test Three times daily Treatment treatment for HIV treatment period Trial Trial registration two-sided Unsuitable Viral viral dynamics Viral load virus was determined website Withdrawal withdrawal of consent
[DOI] 10.1186/s13063-021-05282-w PMC 바로가기 [Article Type] Letter

Disparities of SARS-CoV-2 Nucleoprotein-Specific IgG in Healthcare Workers in East London, UK

Medicine

Published on 2021-04-272022-10-31
Journal: Frontiers in Medicine [Category] COVID-19,

[키워드] Abbott anti-Nucleocapsid IgG antibody Antibody detection Architect Asian black category central London Concordance conducted COVID-19 COVID-19 symptom declining demonstrated determine diagnostic disparity East Effects enrolled enrolment Ethnicity evaluate evaluated Follow-up greater HCW healthcare healthcare worker Healthcare workers hospital hypertension IgG independent predictor Laboratory tests London marker MONITOR NHS Older age participant Participants persistence plasma sample point-of-care positive Prevalence Rapid test Reinfection representing retained risk factor Risk factors SARS-CoV-2 SARS-CoV-2 antibody SARS-CoV-2 IgG SARS-CoV-2 IgG antibody SARS-COV-2 infection Sero-surveillance seroconverted severe COVID-19 illness spread of COVID-19 Trust worker
[DOI] 10.3389/fmed.2021.642723 PMC 바로가기 [Article Type] Medicine

SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN)

영국에서 항체 음성 의료 종사자와 비교한 항체 양성 환자의 SARS-CoV-2 감염률: 대규모, 다기관, 전향적 코호트 연구(SIREN)

Multicenter Study

Published on 2021-04-172022-09-11
Journal: Lancet (London, England) [Category] MERS, SARS, 진단, 치료기술,

[키워드] 95% CI adjusted Analysis antibody Antibody test antibody test) Antibody testing assigned baseline clinically Cohort cohorts COVID-19 defined Department determined by effective eligible England enrolled enrolment Evidence first positive Follow-up frailty future infection had no hazard health-care hierarchy hospital Immunity incidence incidence density incidence rate include Increased individual individuals induce Infection infection rate infection rates infection with SARS-CoV-2 infections Linked data lower risk median median interval multicentre participant Participants PCR PCR positive PCR test PCR testing PCR tests PCR-confirmed Poisson distribution positive positive PCR positive PCR test Potential Primary infection Primary outcome prospective cohort study protective effect Public Health England questionnaire Questionnaires rate ratios recruited Region Reinfection risk SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 PCR Scottish Seroconversion Support Symptom symptomatic and asymptomatic UK Government was done was used were excluded
[DOI] 10.1016/S0140-6736(21)00675-9 PMC 바로가기 [Article Type] Multicenter Study

A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial

SARS-CoV-2 백신(비활성화, Vero 세포)의 효능과 안전성을 평가하기 위한 무작위 이중 맹검 위약 대조 임상 3상 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-132022-09-10
Journal: Trials [Category] MERS, SARS, 비임상, 임상, 치료기술,

[키워드] 1:1 24 hour 24 hours 95% confidence interval Activation Active surveillance administration Administrative Personnel Adverse adverse event adverse events Adverse reaction Adverse reactions African green monkey age Algorithm Aluminium aluminium hydroxide anaphylaxis Antibody test Antibody titer Antigen Arm asplenia assigned assumed assumption Autoimmune baseline bleeding disorders Blinding blood product blood products blood sample Blood samples breastfeeding women breath carried Cell culture China chloride Clinical efficacy clinical trial code Cohort cohorts comparator consent form cooperation Corticosteroid Corticosteroids COVID-19 COVID-19 cases COVID-19 disease COVID-19 symptoms COVID-19 test criteria Critical CRO Data and Safety Monitoring Board Day development diary dihydrogen DIHYDROGEN PHOSPHATE disease disodium disodium hydrogen phosphate dissemination dose dose of vaccination double blind double-blind double-blind study Efficacy Efficacy and safety element eligible Endpoint enrolled enrolment ethics committee evaluate event excluded exclusion criteria expected Follow-up follow-up period Frequency Gender genders green monkey group groups healthcare Healthcare professional healthcare professionals higher risk HIV infection hospital Hospitalization hydrogen Hydrogen phosphate hydroxide hypersensitivity identity IgG level IgG levels IgG test immunogenicity Immunoglobulin immunoglobulins immunosuppressive immunosuppressive therapy inactivated Inactivated Vaccines incidence incidence rate include Inclusion individual information informed consent form initiated Interactive Web Response System intramuscular dose investigator IWRS IWRS system kidney knowledge Local local reactions management medical doctors medical emergency Ministry of Health mortality rates neutralizing antibody Neutralizing antibody titer Novel coronavirus number Nurses objective Omega Other participant PCR PCR positivity performed Phase III Clinical Trial phosphate Placebo placebo group placebo-controlled positive pregnancy test pregnant preparation primary efficacy endpoint professional proportion protocol randomised randomised controlled trial randomised placebo controlled trial randomization Randomized Randomly Reactions receive recorded regimens Registration reported response risk risk of infection RT-PCR RT-PCR test RT-PCR tests Safety Monitoring Board Sample size SARS-CoV-2 vaccine SARS-CoV-2 virus screened second dose secondary Secondary objectives Serious Adverse Event Serious Adverse Events seroconversion rate Seropositivity severity severity of COVID-19 shown Sinovac sodium Sodium chloride sodium dihydrogen phosphate Sponsor status study group Study protocol subject subject’ supplementary material Symptom symptomatic symptomatic case symptomatic cases System systemic adverse reaction the ethics committee the timing the vaccine therapy Treatment treatment arm Trial Turkey two-sided vaccinated groups vaccination Vaccine Vero Vero Cell Web website width with COVID-19 within 6 months
[DOI] 10.1186/s13063-021-05180-1 PMC 바로가기 [Article Type] Letter

Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial

경증 또는 중등도의 COVID-19 폐렴으로 입원한 환자를 위한 염증 신호 억제제(MATIS)의 다군 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-122022-09-10
Journal: Trials [Category] 임상,

[키워드] 24 hours accounted Administered age agreement All participants Allergic reactions approved baseline blind blinded Blinding block Breastfeeding Caregivers cell proliferation childbearing potential clinical clinical outcomes clinically suspected college comparator completion Compliance Concomitant medication Contraception Controlled trial coronavirus COVID-19 COVID-19 disease COVID-19 pneumonia CPAP CRP Data monitoring committee Day death defined Desaturation determine diagnosed disease disease severity dissemination dose drug ECMO effective Efficacy element English enrolment exclusion experimental arm experimental intervention facemask FOS fostamatinib generate GRADE grade 3 Graft graft-versus-host-disease hepatic dysfunction hospital Hospital admission Hospital stay hospitalisation hospitalised patient Hospitalised patients Immune thrombocytopenia Imperial College Healthcare NHS Trust incidence information Informed consent inhibitor Inpatient Inpatients Intervention invasive Invasive mechanical ventilation invasive ventilation investigational agent investigator JAK1 JAK2 janus kinase Kinase inhibitor kinases Laboratory male participants MATIS Mild minimum moderate Moderate COVID-19 moderate to severe Modification multi-arm myelofibrosis nasal oxygen NHS Non-invasive non-invasive ventilation number objective Obstructive obstructive sleep apnoea opinion Ordinal Scale outcome oxygen Pairwise comparison pandemic parallel-group participant Patient Pneumonia polycythaemia vera principal investigator product progression promise proportion protocol random randomisation randomised randomised controlled trial receiving recruit recruited reduce reduce mortality reducing renal impairment renal replacement therapy replacement therapy required Requirement ruxolitinib Sample size sample size calculation Sample size calculations SARS-CoV2 infection scale Secondary objectives selective sequence severe allergic reaction Severe COVID-19 pneumonia severity severity of COVID-19 sexual intercourse signal sleep apnoea Sperm sperm donation spleen Splenomegaly Stage stage 2 Standard Standard of care statistical analysis status Stratification study drug Study protocol supplementary material Symptom systemic inflammation the WHO therapy thrombocytopenia translation Treatment Trial Trial registration Trust tyrosine tyrosine kinase inhibitor Venous Thromboembolism verbal website WHO with COVID-19
[DOI] 10.1186/s13063-021-05190-z PMC 바로가기 [Article Type] Letter