A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273)Research article Published on 2022-08-012022-10-05 Journal: Vaccine [Category] COVID19(2023년), SARS, 변종, 비임상, 임상, [키워드] acute respiratory syndrome assessment authorization Benefit/Risk caused collaboration coronavirus coronavirus disease COVID-19 develop DNA effective Efficacy Efficacy and safety Emergency FDA approval feature group interim analysis key consideration Moderna mRNA mRNA vaccine mRNA-1273 nucleic acid pandemic Phase 3 placebo-controlled platform Prevent RNA Safety SARS-CoV-2 Trial unblinding Vaccine vaccine platform Vaccines working [DOI] 10.1016/j.vaccine.2022.06.005 [Article Type] Research article
Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial코로나19의 바이오마커, 호흡기 중재 및 의료 서비스에 대한 몰누피라비르의 효과 : 무작위, 위약 대조 시험Randomized Controlled Trial Published on 2022-08-012022-09-11 Journal: Annals of internal medicine [Category] COVID19(2023년), MERS, SARS, 바이오마커, 임상, [키워드] 95% CI Analysis assigned baseline benefit C-reactive protein C-reactive protein (CRP Care change clinical benefit clinically Concentration COVID-19 CRP death discharge discharged double-blind Effect evaluated faster Hospitalization Hospitalized identify immunized improvement Improvements Inc Invasive mechanical ventilation less LLC median medical service medical services Mild mild to moderate Mild to moderate COVID-19 Moderate COVID-19 molnupiravir Older oxygen oxygen saturation participant performed Phase 3 Placebo placebo-controlled placebo-treated participant placebo-treated participants potential clinical benefit progression randomization Randomized Randomly receiving reduction in Relative risk respiratory respiratory intervention respiratory interventions risk risk factor Risk factors risk reduction SARS-CoV-2 secondary service severe disease Sharp subsidiary therapy Trial [DOI] 10.7326/M22-0729 PMC 바로가기 [Article Type] Randomized Controlled Trial
Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection: A Phase 2 Dose-Ranging Randomized Clinical TrialSARS-CoV-2 감염 외래 환자에서 Casirivimab과 Imdevimab COVID-19 항체 조합의 바이러스학적 효능: 2상 용량 범위 무작위 임상 시험Clinical Trial Published on 2022-08-012022-09-12 Journal: JAMA Network Open [Category] SARS, 임상, 진단, [키워드] 95% CI Administered age Asymptomatic average baseline Casirivimab clinical collected COVID-19 death dose double-blind Efficacy efficacy analysis greater Hispanic Hospitalization hypersensitivity reactions Imdevimab in viral intravenous mean difference monoclonal antibody combination outcome Outpatient parallel-group participant Participants Patient patients Phase 2 Phase 3 Placebo placebo-controlled primary end point Randomized randomized clinical trial ranged Reactions reduced reduction reported risk factor SARS-CoV-2 SARS-COV-2 infection Serious Adverse Event seronegative severe COVID-19 study drug Subcutaneous symptomatic symptomatic patient The United States Treatment Viral load were excluded white [DOI] 10.1001/jamanetworkopen.2022.25411 PMC 바로가기 [Article Type] Clinical Trial
Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trialClinical Trial Published on 2022-07-082022-10-05 Journal: The Lancet. Respiratory Medicine [Category] 임상, 진단, 치료법, [키워드] 1:1 addition adverse event Analysis assigned baseline Cohort Complete COVID-19 cumulative defined double-blind Europe extracorporeal membrane oxygenation finding Follow-up funding hazard ratio hospital discharge hospitalised hypothesised IMPROVE incidence infused intravenous Invasive mechanical ventilation investigators modified intention-to-treat monoclonal antibody combination Mortality neutralising NIH occurred operation Organ failure outcome participant Patient Phase 3 phase 3 trial Placebo placebo group placebo-controlled trial Primary outcome randomised Randomly receive receiving Registered Remdesivir renal replacement therapy Result Safe seronegative Singapore speed standard care study drug Study participants Support sustained Symptom the placebo group therapy Treatment Uganda USA were excluded with COVID-19 [DOI] 10.1016/S2213-2600(22)00215-6 [Article Type] Clinical Trial
The impact of COVID-19 vaccination program in the Republic of San Marino: focus on effectiveness of Gam-COVID-VacResearch article Published on 2022-07-012022-10-05 Journal: Clinical microbiology and infection : the official [Category] COVID19(2023년), SARS, 변종, 임상, [키워드] adenovirus-based adjusted bimester BNT162b2 calculated concerning conducted COVID-19 COVID-19 vaccination COVID-19-related death declining demonstrated dose Effectiveness Gam COVID-Vac Gam-COVID-Vac Hospitalization hospitalizations incidence rate multivariable objective peaked Phase 3 population level protection Rate Ratio Regression model reported Result retrospective SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 vaccination second dose Sputnik V study period subject the vaccine vaccination vaccination schedule Vaccine variant with COVID-19 [DOI] 10.1016/j.cmi.2022.06.026 [Article Type] Research article
Efficacy and safety of an inactivated whole-virion vaccine against COVID-19, QazCovid-in®, in healthy adults: A multicentre, randomised, single-blind, placebo-controlled phase 3 clinical trial with a 6-month follow-upResearch article Published on 2022-06-252022-10-05 Journal: EClinicalMedicine [Category] 변종, 임상, [키워드] 95% CI Administered adverse events assigned chronic heart failure clinical trial Committee concomitant disease conducted Coronavirus infection COVID-19 COVID-19 case diagnosed dose education effective Efficacy eligible participant finding first dose Follow-up follow-up period funding healthy hydroxide inactivated incidence Infection intramuscular intramuscularly Kazakhstan Local multicenter multicentre not affect observation period Older participant Participants Phase 3 Placebo placebo-controlled Prevent primary endpoint Program Protective randomised Randomly reached receive Registered RT-PCR Safe Science severe COVID-19 short-lived single-blind Spread state symptomatic case the SARS-CoV-2 the SARS-CoV-2 virus the vaccine Trial Vaccine Vaccines virus were recorded [DOI] 10.1016/j.eclinm.2022.101526 [Article Type] Research article
Evaluation of the safety and immunogenicity of different COVID-19 vaccine combinations in healthy individuals: study protocol for a randomized, subject-blinded, controlled phase 3 trial [PRIBIVAC]건강한 개인에서 다양한 COVID-19 백신 조합의 안전성 및 면역원성 평가: 무작위, 피험자 맹검, 대조 3상 시험을 위한 연구 프로토콜 [PRIBIVAC]Article Published on 2022-06-162022-09-11 Journal: Trials [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] adverse event adverse events anti-SARS-CoV-2 antibodies antibody approval best blood sample Blood samples BNT162b2 boost booster booster dose booster vaccinations cellular Cellular immune response collected Combination Comprehensive control arm Controlled clinical trial CoronaVac country COVID-19 COVID-19 vaccination COVID-19 vaccine COVID-19 vaccines demonstration different time point different time points dose Effectiveness Eligible participants Endpoint enrolment evade excluded group healthy Heterologous homologous host immunity humoral immune immune profiling immune response Immunity Immunocompromised immunogenicity Immunoglobulin immunoglobulins Inactivated vaccine Infection Intervention intervention arm Laboratory test Laboratory tests Local maintain mRNA mRNA vaccine mRNA-1273 omicron over parameters participant performed persistence phase Phase 3 phase 3 trial physical population immunity pregnant primary endpoint Probability quantity raising randomization Randomized Randomized controlled trial regimen Regulatory SARS-CoV-2 SARS-COV-2 infection Serious Adverse Event Serious Adverse Events Singapore Study protocol vaccination Vaccine vaccine availability vaccine booster vaccine candidate variants variants of concern volunteers wildtype [DOI] 10.1186/s13063-022-06345-2 PMC 바로가기 [Article Type] Article
Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trialClinical Trial Published on 2022-06-072022-10-05 Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 임상, 진단, 치료법, 치료제, [키워드] 1:1 95% CI administration Adverse age Antigen assigned AstraZeneca block sizes blocked clinical clinical evaluation clinically collected conducted Course COVID-19 COVID-19 vaccination death dose double-blind Efficacy enrolled enrolment Europe evaluate event Fever finding for inclusion funding individual intramuscular intramuscular injections investigators involved Japan laboratory-confirmed SARS-CoV-2 infection Latin America less Mild moderate Moderate COVID-19 monoclonal antibody combination non-hospitalised occurred Older outcomes participant Phase 3 Placebo placebo-controlled study placebo-controlled trial prevent disease progression primary endpoint progression provided randomisation randomised Randomly receive Registered required respiratory tract risk reduction RT-PCR scale severe COVID-19 severity specimen Sponsor statistically stratified study drug Symptom symptom onset the disease the placebo group treating Treatment treatment group USA WHO [DOI] 10.1016/S2213-2600(22)00180-1 [Article Type] Clinical Trial
Favipiravir, camostat, and ciclesonide combination therapy in patients with moderate COVID-19 pneumonia with/without oxygen therapy: An open-label, single-center phase 3 randomized clinical trialResearch article Published on 2022-06-032022-10-05 Journal: EClinicalMedicine [Category] 신약개발, 임상, 치료제, [키워드] 95% CI Admission Adverse AMED assigned calculated camostat Characteristics Ciclesonide clinical Clinical finding Clinical management Combination combination therapy comparable COVID-19 COVID-19 infection deaths decrease development discharge Effectiveness enrolled evaluated event Favipiravir finding funding group groups healthcare worker hospital discharge rate Hospital stay Hospitalization Hospitalized Japan Japanese lack less limitation median time Ministry of Health monotherapy no significant difference number Open-label oxygen participant Patient patients patients with moderate Phase 3 phase 3 study Pneumonia positive Primary outcome randomized clinical trial Randomized controlled trial Randomly Registered registry Research SARS-CoV-2 Severe COVID-19 Infection significantly higher significantly lower single-center statistically supported therapy Treatment vaccination Version Welfare [DOI] 10.1016/j.eclinm.2022.101484 [Article Type] Research article
Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine재조합 식물 기반 면역증강제 코로나19 백신의 효능 및 안전성Clinical Trial Published on 2022-06-022022-09-11 Journal: The New England Journal of Medicine [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, 치료기술, 치료법, 치료제, [키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adjuvant adverse event age Analysis AS03 assigned baseline candidate vaccine caused conducted coronavirus coronavirus disease Coronavirus disease 2019 CoVLP CoVLP+AS03 determine disease dose effective Efficacy Factor FIVE incidence injection intention-to-treat intention-to-treat population Intramuscular injection Local median age Median viral load Medicago Mild moderate occurred participant Participants participated Particle performed Phase 3 Placebo placebo group placebo-controlled trial plant plants polymerase post-hoc analysis prefusion produced Randomized receive recombinant respiratory Safety SARS-CoV-2 sequenced Sequencing seronegative severe acute respiratory syndrome Coronavirus Severe case Spectrum spike glycoprotein symptomatic symptomatic COVID-19 symptomatic infection System systemic adverse event systemic adverse events the median the placebo group the vaccine Trial two group two groups Vaccine vaccine efficacy vaccine group variant variants Viral Viral load viral sample Volunteer [DOI] 10.1056/NEJMoa2201300 PMC 바로가기 [Article Type] Clinical Trial