Characterizing SARS-CoV-2 Viral Clearance Kinetics to Improve the Design of Antiviral Pharmacometric StudiesSARS-CoV-2 바이러스 제거 동역학 특성화를 통해 항바이러스 약리학적 연구 설계 개선Article Published on 2022-07-192022-09-11 Journal: Antimicrobial Agents and Chemotherapy [Category] COVID19(2023년), SARS, 임상, 치료기술, 치료제, [키워드] analyzed Antiviral antiviral drug antiviral drugs antiviral effects antiviral treatments assessment clearance clearance rate clinical trials conducted Consensus COVID-19 illness Effect estimate exponential decay model individuals Infection Kinetics methodology Metrics molnupiravir Nasopharyngeal swab Nasopharyngeal swab samples Nirmatrelvir Patient Pharmacodynamics Phase 2 profile provide qPCR randomized trial randomized trials reduced reported robust Sample size sample sizes SARS-CoV-2 splines Statistical power time to clearance. Trial viral clearance Viral load virological response [DOI] 10.1128/aac.00192-22 PMC 바로가기 [Article Type] Article
Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variants면역의 지속성과 새로운 변이체에 대한 비활성화된 COVID-19 백신 3차 접종의 영향Clinical Trial Published on 2022-07-142022-09-11 Journal: Scientific Reports [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, 치료기술, 치료법, [키워드] (alpha Alpha Antibody titers B cell memory Beta booster booster dose Breakthrough infection breakthrough infections Cell mediated immunity clinical concern Controlled trial COVID-19 COVID-19 vaccine COVID-19 vaccines D614G Delta dose double-blind Effectiveness Heterologous homologous humoral humoral and cell mediated immunity Immunity immunogenicity inactivated India injection injection site itching magnitude neutralization titer Neutralizing antibodies neutralizing antibody omicron Pain persistence Phase 2 question Randomized controlled trial recipient redness registry responses Safe Serious Adverse Event Serious Adverse Events slight increase strain Trial registration vaccination variant variants VOCs within 6 months [DOI] 10.1038/s41598-022-16097-3 PMC 바로가기 [Article Type] Clinical Trial
Impact of previous exposure to SARS-CoV-2 and of S-Trimer (SCB-2019) COVID-19 vaccination on the risk of reinfection: a randomised, double-blinded, placebo-controlled, phase 2 and 3 trialSARS-CoV-2 및 S-Trimer(SCB-2019) COVID-19 백신에 대한 이전 노출이 재감염 위험에 미치는 영향: 무작위 배정, 이중 맹검, 위약 대조, 2상 및 3상 시험Clinical Trial Published on 2022-07-012022-09-11 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), SARS, 변종, 임상, [키워드] 1:1 95% CI addition Alpha assigned attack rates B.1.1.7 B.1.351 B.1.617.2 B.1.621 baseline Beta calculate CEPI Clover Coalition confirmed case COVID-19 COVID-19 infection COVID-19 vaccination COVID-19 vaccine dose double-blind double-blinded Efficacy enrolled Evidence evidence of exposure to FIVE groups hospitalisation Impact injection site pain Innovation IQVIA Lambda Local lowest moderate-to-severe COVID-19 multicentre no evidence of P.1 participant Participants Phase 2 Placebo placebo-controlled placebo-controlled trial Primary outcome Primary outcomes protection Protective randomised Randomly Rate reactogenicity Real-time PCR receive recipients recombinant Reinfection reported response risk SARS-CoV-2 SARS-CoV-2-naïve participants SCB-2019 Secondary analyses secondary analysis Serious Adverse Event Serious Adverse Events severe adverse events severe COVID-19 severity subsequent subset symptomatic systemic adverse event systemic adverse events technology Trial USA vaccination Vaccine vaccine dose vaccine efficacy variant variants Viral variants with COVID-19 [DOI] 10.1016/S1473-3099(22)00144-X PMC 바로가기 [Article Type] Clinical Trial
Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial무작위 2상 시험에서 BBIBP-CorV 수용자에서 하이브리드형 백신 부스터의 안전성 및 면역원성Clinical Trial Published on 2022-06-272022-09-11 Journal: Nature Communications [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, 치료기술, 치료법, [키워드] 1:1 Administered Adverse reaction Adverse reactions age Antigen antigens BBIBP-CorV boost booster booster dose conducted dose double-blind elicited evaluate GMT greater group healthy Heterologous homologous IgG antibodies IgG antibody immunogenic immunogenicity incidence Neutralizing and IgG antibodies neutralizing antibody omicron Omicron variant participant Phase 2 phase 2 trial Randomized receive recipient recombinant COVID-19 vaccine regimens Safe Safety safety profile SARS-CoV-2 SARS-CoV-2 strain significantly higher three groups United Arab Emirate United Arab Emirates Vaccine variant variants of concern VOCs [DOI] 10.1038/s41467-022-31379-0 PMC 바로가기 [Article Type] Clinical Trial
Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial건강한 어린이에서 비활성화된 COVID-19 백신 WIBP-CorV의 안전성 및 면역원성: 무작위, 이중 맹검, 대조, 1/2상 시험의 중간 분석Clinical Trial Published on 2022-06-242022-09-11 Journal: Frontiers in Immunology [Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료기술, [키워드] adverse events Adverse reaction Adverse reactions age alum Antibody Response assigned children China clinical trial Cohort cohorts conducted Controlled COVID-19 COVID-19 vaccine detectable dose dose-escalation double-blind effective vaccine Effective vaccines elicited Escalation Fever followed by geometric mean geometric mean titer geometric mean titers grade 3 groups healthy children Humoral response immunogenicity inactivated Inactivated vaccine injection injection site pain Interim Intramuscular injection Mild neutralizing antibody participant phase Phase 1 phase 1 trial Phase 2 phase 2 trial Placebo placebo-controlled Randomized Randomly ranged Registered robust Safe Safety safety profile SARS-CoV-2 significantly higher tested three group three groups vaccination Vaccine [DOI] 10.3389/fimmu.2022.898151 PMC 바로가기 [Article Type] Clinical Trial
Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial6~17세 어린이 대상 ChAdOx1 nCoV-19(AZD1222) 백신의 안전성 및 면역원성: 2상 단일 맹검, 무작위, 대조 시험인 COV006의 예비 보고서Clinical Trial Published on 2022-06-112022-09-11 Journal: Lancet (London, England) [Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료법, [키워드] 95% CI administration Adults adverse event adverse events age All participants anti-SARS-CoV-2 IgG antibody Antibody titre antibody titres arbitrary unit assigned AstraZeneca AZD1222 baseline capsular Cellular responses ChAdOx1 ChAdOx1 nCoV-19 children chronic respiratory conditions Concentration Controlled trial COVID-19 COVID-19 vaccine COVID-19 vaccines Cutoff Department dose doses Efficacy enrolled Fever first dose first vaccination four group four groups geometric geometric mean geometric mean ratios Geometric means group half-maximal inhibitory concentration Humoral response humoral responses immune response immune responses immunogenic immunogenicity in some intramuscular dose introduced investigators ISRCTN Laboratory laboratory-confirmed Laboratory-confirmed COVID-19 Local nucleocapsid protein Pain and tenderness participant Participants peaked Phase 2 phase 3 study preliminary report Primary outcome prime and boost raised randomised Randomly receive receiving recruitment Registered remained reported resolved respiratory response Safety safety population SARS-CoV-2 second dose second vaccination secondary outcome Serious Adverse Event Serious Adverse Events seronegative seronegative participant seronegative participants seropositive serostatus single-blind stratified study drug study groups tenderness Tolerability treatment allocation Trial vaccination Vaccine Viral viral particle were recorded [DOI] 10.1016/S0140-6736(22)00770-X PMC 바로가기 [Article Type] Clinical Trial
Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV: a phase 2 trialBBIBP-CorV로 프라이밍한 후 이종 부스터로서의 NVSI-06-07의 면역원성과 안전성: 2상 시험Clinical Trial Published on 2022-06-062022-09-11 Journal: Signal Transduction and Targeted Therapy [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] 1:1 Adverse reactions Alpha assigned BBIBP-CorV Beta boost booster booster vaccination conducted control groups coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 vaccine Delta double-blinded elicited followed by geometric mean geometric mean titer GMT GMTs group groups healthy Heterologous heterologous prime-boost homologous immunogenic immunogenicity immunogenicity assays inactivated increase Increases indicated individual Mild moderate Neutralizing neutralizing antibody omicron Omicron variant Participants Phase 2 phase 2 trial priming prototype randomised Randomly receive recipient Recombinant protein Safe safety profile SARS-CoV-2 SARS-CoV-2 variant significantly higher systemic adverse reaction three groups vaccination Vaccine variant VOCs [DOI] 10.1038/s41392-022-00984-2 PMC 바로가기 [Article Type] Clinical Trial
Reply to Carlos G. Wambier and Gerard J. Nau’s Letter to the Editor re: Karin Welén, Ebba Rosendal, Magnus Gisslén, et al. A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data. Eur Urol. 2022;81:285–93. Positive Effects of Enzalutamide for Hospitalized COVID-19 Patients: Still No Positive Effect of Enzalutamide for Hospitalized COVID-19 PatientsCorrespondence Published on 2022-06-012022-10-05 Journal: European urology [Category] 임상, [키워드] antiandrogen COVID-19 Effect enzalutamide evidence of Magnus Phase 2 Reply Still [DOI] 10.1016/j.eururo.2022.02.016 [Article Type] Correspondence
Re: Karin Welén, Ebba Rosendal, Magnus Gisslén, et al. A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data. Eur Urol. 2022;81:285-93: Positive Effects of Enzalutamide for Hospitalized COVID-19 PatientsClinical Trial Published on 2022-06-012022-10-05 Journal: European urology [Category] Fulltext, MERS, 임상, [키워드] antiandrogen COVID-19 Effect enzalutamide evidence of Magnus Phase 2 [DOI] 10.1016/j.eururo.2022.01.049 PMC 바로가기 [Article Type] Clinical Trial
Persistence of immunogenicity after seven COVID-19 vaccines given as third dose boosters following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK: Three month analyses of the COV-BOOST trial영국에서 ChAdOx1 nCov-19 또는 BNT162b2 2회 접종 후 3차 추가 접종으로 7가지 COVID-19 백신을 투여한 후 면역원성의 지속성: COV-BOOST 시험의 3개월 분석Clinical Trial Published on 2022-06-012022-09-11 Journal: The Journal of Infection [Category] COVID19(2023년), MERS, SARS, 변종, 유전자 메커니즘, 임상, 진단, [키워드] Ad26 Ad26.COV2.S adenoviral vector adenoviral vector vaccine Analysis anti-Spike IgG antibody AstraZeneca BNT BNT162b2 booster booster dose cellular response Cellular responses ChAd ChAdOx1 ChAdOx1 nCoV-19 Concentration conducted COV-BOOST COVID-19 COVID-19 vaccine Critical death dose doses evaluate Fractional dose geometric mean geometric mean concentration geometric mean ratio GMR GMRs Heterologous boost highest Homologous boost humoral Humoral response immune response immune responses immunogenicity initial janssen long-lasting maintenance median age mRNA mRNA vaccine mRNA vaccines multicentre naïve no significant difference Oxford-AstraZeneca participant persistence Pfizer-BioNTech Phase 2 phase 2 trial randomised referred to response responses SARS-CoV-2 Seven severe disease significant difference significantly higher the vaccine third dose Transmission Trial Vaccine Vaccines variants of concern while [DOI] 10.1016/j.jinf.2022.04.018 PMC 바로가기 [Article Type] Clinical Trial