Phase 2 – Page 6 – Communicable Diseases Research

Levocetirizine and montelukast in the COVID-19 treatment paradigm

Research article

Published on 2022-02-012022-10-05
Journal: International immunopharmacology [Category] COVID19(2023년), SARS, 변종, 신약개발, 치료법,

Randomised controlled trial of intravenous nafamostat mesylate in COVID pneumonitis: Phase 1b/2a experimental study to investigate safety, Pharmacokinetics and Pharmacodynamics

COVID 폐렴에서 정맥내 나파모스타트 메실레이트의 무작위 대조 시험: 안전성, 약동학 및 약력학을 조사하기 위한 1b/2a상 실험 연구

Clinical Trial

Published on 2022-02-012022-09-11
Journal: EBioMedicine [Category] COVID19(2023년), MERS, SARS, 바이오마커, 신약개발, 임상, 치료제,

[키워드] 95% CI Administered adverse events Analysis Anti-inflammatory Anticoagulant anticoagulant effect anticoagulant effects antiviral activity assigned average characterisation Controlled trial COVID COVID-19 COVID19 creatinine credible interval demonstrated dose Edinburgh Endpoint endpoints Evidence evidence of Hospital stay hospitalised hospitalised patient Hospitalised patients inactive independent Infectious diseases intravenous intravenous infusion manuscript maximum mean difference mesylate metabolites nafamostat Nafamostat mesylate observé Odds ratio open open label Oxford oxygen Patient patients Pharmacodynamics pharmacokinetics phase Phase 2 PK data plasma platform Pneumonitis Primary outcome Primary outcomes progressed randomised randomised controlled trial Randomly rate ratio receive reported Repurposed drug Research respiratory Respiratory medicine response SARS-CoV-2/COVID-19 Seven significantly higher significantly more SOC Standard of care statistically significant difference therapy Tolerability Total Total manuscript word count. Trial university with COVID-19
[DOI] 10.1016/j.ebiom.2022.103856 PMC 바로가기 [Article Type] Clinical Trial

Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial

보조제 서브유닛 단백질 COVID-19 백신, SCB-2019의 효능: 2상 및 3상 다기관, 이중 맹검, 무작위 배정, 위약 대조 시험

Clinical Trial

Published on 2022-01-292022-09-11
Journal: Lancet (London, England) [Category] 변종, 임상,

[키워드] 1:1 95% CI alum assigned baseline Belgium biopharmaceutical Brazil caused chloride circulating Clover Coalition country COVID 19 COVID-19 COVID-19 case COVID-19 vaccine CpG Cutoff dose doses double-blind effective vaccine Effective vaccines Efficacy efficacy analysis elicited Endpoint enrolled EudraCT exclusion FIVE follow-up period groups Health health condition injection injection site pain intramuscular dose Local median Mild-to-moderate moderate-to-severe COVID-19 MOST multicentre notable Older pandemic participant per-protocol per-protocol population Phase 2 Placebo placebo recipients placebo-controlled trial predominant primary endpoints Protein provide randomisation randomised Randomly receive Registered RT-PCR Safe SAR-CoV-2 SARS CoV SARS-CoV-2 SCB-2019 second dose seronegative participant Seropositivity severe COVID-19 severity Sodium chloride South Africa subset subunit systemic adverse event systemic adverse events Vaccine vaccine efficacy vaccinee vaccinees variant virus virus variants viruses was done
[DOI] 10.1016/S0140-6736(22)00055-1 PMC 바로가기 [Article Type] Clinical Trial

University population-based prospective cohort study of SARS-CoV-2 infection and immunity (SARSSURV-ULiège): a study protocol

SARS-CoV-2 감염 및 면역에 대한 대학 인구 기반 전향적 코호트 연구(SARSSURV-ULiège): 연구 프로토콜

Article

Published on 2022-01-252022-09-11
Journal: BMJ Open [Category] SARS, 진단, 치료기술,

[키워드] activity All participant All participants Antibody Response Antibody responses Antibody testing approval blood sample Blood samples cohort study collected Complete COVID-19 COVID-19 pandemic detect determine Epidemiology Ethics ethics committee Evidence flexible higher education immune response Immunity immunology incidence Infection lack magnitude management medical histories MONITOR Neutralising Antibodies neutralising antibody participant Phase 1 Phase 2 population-based cohort positive Potential Prevalence profiles prospective cohort study protocol amendment public health questionnaire Rapid test rapid test result reference number Registered required Research Research Ethics Research Ethics Committee respond risk Risk assessment Risk management RT-qPCR Safe Saliva SARS-CoV-2 SARS-CoV-2 antibody testing SARS-COV-2 infection serological serological test Seroprevalence Stage student study period Study protocol submitted university university hospital vaccination Vaccine hesitancy Weekly
[DOI] 10.1136/bmjopen-2021-055721 PMC 바로가기 [Article Type] Article

How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials.gov

초기 SARS-COV-2 치료 및 예방 시험은 얼마나 유익 했습니까?ClinicalTrials.gov에 등록 된 시험의 종단 코호트 분석

Research Article

Published on 2022-01-212022-09-10
Journal: PLoS ONE [Category] SARS, 임상, 치료제,

[키워드] amplified Arm Behavioural intervention behavioural interventions Characteristics Clinical research ClinicalTrials Cohort cohort analysis confidence confidence interval COVID COVID-19 criteria drug Efficacy eligibility criteria eligible evaluated exceptional excluded FDA feasibility food Guidance initiated interval over pandemic phase Phase 2 Prevalence Primary outcome proportion recommendation recruitment redundancy Registered regulated reported Research Result SARS-CoV-2 SARS-CoV-2 pandemic SARS-CoV-2 treatment the SARS-CoV-2 Timeliness Treatment treatment regimen Trial trials U.S. Food and Drug Administration
[DOI] 10.1371/journal.pone.0262114 PMC 바로가기 [Article Type] Research Article

A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19

중증 COVID-19 환자의 회복기 혈장 치료를 위한 2상 단일 센터 공개 라벨 무작위 대조 시험

Clinical Trial

Published on 2022-01-192022-09-12
Journal: Nature Communications [Category] SARS, 임상, 진단, 치료기술, 치료법,

[키워드] 95% confidence interval adverse effect Adverse reaction all-cause mortality ARDS benefit characterized clinical clinical benefit clinical trial clinical trials Controlled trial convalescent plasma Convalescent plasma therapy COVID-19 disease cytokine Cytokines enrolment Evidence FiO2 General Hospital hazard hyper-inflammation immunization immunological inclusion criteria India Infectious disease Infectious diseases Intervention Kolkata log-rank log-rank test Mantel-Haenszel mechanical ventilation Mild Mild ARDS moderate moderate ARDS Mortality neutralizing antibody not affect not significantly different on mechanical ventilation open label outcome Outcomes research p value PaO2 paO2/fiO2 passive immunization Patient patients patients hospitalized PCR Phase 2 plasma plasma therapy prespecified outcomes Primary outcome Primary outcomes proteome randomised randomised controlled trial Randomized Ratio recruited Registered registry reported response to therapy secondary outcome Secondary outcomes severe COVID-19 severe COVID-19 disease severe COVID-19 patient severe COVID-19 patients single center Standard of care systemic hyper-inflammation the systemic hyper-inflammation therapy treat Treatment treatment arm Trial viral infection Viral RNA was done
[DOI] 10.1038/s41467-022-28064-7 PMC 바로가기 [Article Type] Clinical Trial

Preclinical evaluation of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B

SARS-COV-2 mRNA 백신 PTX-Covid19-B의 전임상 평가

Research Article

Published on 2022-01-192022-09-10
Journal: Science Advances [Category] 변종, 비임상, 신약개발, 진단,

Determining the Prevalence and Incidence of SARS-CoV-2 Infection in Prisons in England: Protocol for a Repeated Panel Survey and Enhanced Outbreak Study

Protocol

Published on 2022-01-122022-10-29
Journal: JMIR Research Protocols [Category] COVID-19,

[키워드] Analysis antibody calculated Characteristics collected Community condition COVID-19 COVID-19 pandemic Data collection Department Determining Diseases eligible England enhanced enrolled Epidemiology facilitate Factor Factors for inclusion Health Health inequalities Identifier incidence rate include Inclusion individual initial Lateral flow device management nasal swab Nasopharyngeal swab objective outbreak Outbreaks pandemic Panel participant Participants Phase 1 Phase 2 polymerase chain positive Positive test Practitioner prison proportion public health Public Health England repeated report Result SARS-CoV-2 SARS-CoV-2 antigen SARS-COV-2 infection selected Spread staff survey tested Testing unique university Ventilated
[DOI] 10.2196/30749 PMC 바로가기 [Article Type] Protocol

Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial

영국에서 2 가지 용량의 Chadox1 NCOV-19 또는 BNT162B2에 따른 3 가지 용량 (부스터)으로서 7 개의 코비드 -19 백신의 안전성 및 면역 원성

Clinical Trial

Published on 2021-12-182022-08-13
Journal: Lancet (London, England) [Category] Fulltext, SARS, 임상,

[키워드] 95% CI Ad26 Ad26.COV2.S adverse event age anti-Spike IgG antibody assigned blinded BNT BNT162b2 booster booster vaccination booster vaccines cellular response Cellular responses ChAd ChAdOx1 ChAdOx1 nCoV-19 Control control group control groups Course COV-BOOST COVID-19 COVID-19 vaccine CureVac CVn CVnCoV dose eligibility criteria ELISA female finding FIVE funding generate geometric mean geometric mean ratio geometric mean ratios GMR GMRs group humoral Humoral and cellular responses immunogenicity individuals initial intention-to-treat population investigated IQR ISRCTN janssen laboratory-confirmed SARS-CoV-2 infection Local m1273 median age MenACWY meningococcal conjugate vaccine Moderna modified intention-to-treat mRNA1273 multicentre neutralising response neutralising responses Novavax NVX NVX-CoV2373 Older Older age outcome Pain participant Participants Pfizer Phase 2 phase 2 trial primary analysis quadrivalent meningococcal conjugate vaccine randomised Randomly ranged reactogenicity referred to Registered Safety SARS-COV-2 infection screened secondary Secondary outcomes Serious Adverse Events Seven spike IgG systemic adverse events the median three group three groups treat treatment allocation Trial Vaccine vaccine availability Valneva Viral viral neutralisation VLA2001 were assessed were blinded white wild-type
[DOI] 10.1016/S0140-6736(21)02717-3 PMC 바로가기 [Article Type] Clinical Trial

Achievements of the COVID-19 Turkey Platform in vaccine and drug development with an approach of “co-creation and succeeding together”

“공동 창조와 성공”의 접근 방식으로 백신 및 약물 개발에서 Covid-19 칠면조 플랫폼의 업적

Review

Published on 2021-12-172022-08-31
Journal: Turkish Journal of Medical Sciences [Category] SARS, 신약개발,