treatment-emergent adverse event – Communicable Diseases Research

Preclinical assessment and randomized Phase I study of CT-P63, a broadly neutralizing antibody targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Article

Published on 2022-12-012022-11-15
Journal: Emerging Microbes & Infections
[Category] COVID19(2023년), SARS, 변종, 비임상, 진단, 치료기술, 치료제,

Comparative efficacy and safety of pharmacological interventions for severe COVID-19 patients: An updated network meta-analysis of 48 randomized controlled trials

Article

Published on 2022-10-142022-11-15
Journal: Medicine
[Category] meta-analysis, 진단,

Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

Article

Published on 2022-09-072022-10-06
Journal: The Lancet. Respiratory Medicine
[Category] COVID19(2023년), SARS, 진단,

[키워드] 1:1 95% CI Acute kidney injury acute respiratory distress addition all-cause mortality all-cause mortality rate Analysis antibody assigned Belgium Block randomisation Brazil C5a Critically ill defined determine died dose double-blind eligible excluded France Germany hazard ratio hospital hospital discharge IMPROVE intravenously intubation invasive Invasive mechanical ventilation ITT analysis Kaplan-Meier analysis matching placebo mechanically ventilated patient monoclonal antibody Mortality multicentre Netherlands Older one patient outcome PaO participant Patient patient population phase 2 trial phase 3 trial Placebo placebo-controlled Pneumonia primary analysis Primary outcome random assignment randomised Randomly receive receiving reduced Registered reported Research Russia Safe safety analysis Safety analysis SARS-COV-2 infection Septic shock shown significant decrease significantly South Africa Standard of care survival TEAE the placebo group therapy Treatment treatment-emergent adverse event variant vilobelimab viral infections was performed with COVID-19
[DOI] 10.1016/S2213-2600(22)00297-1 PMC 바로가기 [Article Type] Article

Repeat subcutaneous administration of casirivimab and imdevimab in adults is well-tolerated and prevents the occurrence of COVID-19

Randomized Controlled Trial

Published on 2022-09-012022-10-04
Journal: International Journal of Infectious Diseases
[Category] COVID19(2023년), SARS, 임상, 진단,

[키워드] administration adverse event antibody Casirivimab clinically conducted COVID-19 death defined demonstrated development dose doses double-blind Efficacy end point evaluate evaluated exploratory hypersensitivity reaction Imdevimab incidence of COVID-19 laboratory-confirmed monoclonal antibody occurred Occurrence occurrence of COVID-19 Odds ratio participant Placebo placebo-controlled trial Prevent proportion Randomized reaction reduction in Repeat reported risk reduction SARS-CoV-2 SARS-CoV-2. Seroconversion substantial risk Tolerability treatment period treatment-emergent adverse event uninfected volunteers
[DOI] 10.1016/j.ijid.2022.06.045 PMC 바로가기 [Article Type] Randomized Controlled Trial

Pepinemab antibody blockade of SEMA4D in early Huntington’s disease: a randomized, placebo-controlled, phase 2 trial

Research

Published on 2022-08-082022-10-05
Journal: Nature Medicine
[Category] 바이오마커, 변종, 임상, 치료법,

Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial

Randomized Controlled Trial

Published on 2022-07-052022-10-05
Journal: The Lancet. Infectious Diseases
[Category] COVID19(2023년), SARS, 변종, 임상, 진단,

[키워드] 1:1 active against addition age Analysis assigned B.1.1.529 baseline Community Complete COVID-19 COVID-19 symptom COVID-19 vaccination COVID-19 vaccine death diagnostic dose double-blind drugs Efficacy Endpoint expected finding follow-up period funding Health healthy Hoffmann-La Roche hospitalised household contact immune response incidence infected individuals Infectious diseases investigator Local monoclonal antibody combination mounted occurred participant patient population Placebo placebo-controlled trial post-hoc post-hoc analysis prespecified analysis prevented prevention of COVID-19 Prophylaxis proportion provided randomisation randomised Randomly receive receiving reduced Regeneron Pharmaceuticals Registered reported risk of COVID-19 risk reduction Romania RT-PCR testing SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2-infected individual Seroconversion seronegative seropositive shown single dose strain stratified subcutaneous injection susceptible symptomatic SARS-CoV-2 infection the placebo group timepoint treatment-emergent adverse event treatment-emergent adverse events uninfected unmet need USA variants waned
[DOI] 10.1016/S1473-3099(22)00416-9 [Article Type] Randomized Controlled Trial

A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes

Research

Published on 2022-06-242022-10-05
Journal: Nature Communications
[Category] 임상, 진단,

Safety of DW-MSC infusion in patients with low clinical risk COVID-19 infection: a randomized, double-blind, placebo-controlled trial

Clinical Trial

Published on 2022-04-012022-10-05
Journal: Stem Cell Research & Therapy
[Category] 임상,

[키워드] Adverse adverse events baseline Biomarker Cell cells change Clinical characteristics Clinical course clinical risk clinical trial complications Course COVID-19 COVID-19 infection Cytokines discharged dose dose-dependent double-blind Efficacy enrolled exhibited feasibility follow-up period group groups High-dose hospital immunomodulatory properties improve clinical outcome Inflammatory marker Liver function low-dose Mesenchymal stem cells MSC MSCs observation period Occurrence outcome Patient Placebo placebo-controlled placebo-controlled trial profile progression provided Randomized randomized clinical trial Randomized controlled trial Safety Safety. SARS-CoV-2 severity single intravenous infusion stem cell study group study groups study period subject TEAE therapeutic efficacy therapeutic potential therapy Tolerability treated treatment-emergent adverse event vital sign
[DOI] 10.1186/s13287-022-02812-4 PMC 바로가기 [Article Type] Clinical Trial

Efficacy and safety of current treatment interventions for patients with severe COVID-19 infection: A network meta-analysis of randomized controlled trials

심각한 CovID-19 감염 환자에 대한 현재 치료 중재의 효능 및 안전성 : 무작위 대조 시험의 네트워크 메타 분석

Article

Published on 2022-04-012022-08-31
Journal: Journal of medical virology
[Category] COVID19(2023년), meta-analysis, SARS,

[키워드] 95% CI 95% confidence interval Abstract ACM all-cause mortality Auxora Azithromycin Characteristics Chinese controlled trials convalescent plasma coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 infection CP group database databases demonstrated dosage Efficacy Efficacy and safety English language Infection interferon beta Lopinavir Lopinavir-ritonavir medication medications Methylprednisolone Network meta-analysis Odds ratio Older participant Patient Placebo placebo group Randomized Randomized controlled trial Randomized controlled trials RCT RCTs Remdesivir Ritonavir Safety sarilumab searched severe coronavirus disease severe COVID-19 Severe COVID-19 Infection severe COVID-19 patients severe COVID-19. significant decrease Standard of care TEAE TEAEs therapy Tocilizumab treatment intervention treatment-emergent adverse event treatment-emergent adverse events Trial α-lipoic acid
[DOI] 10.1002/jmv.27512 PMC 바로가기 [Article Type] Article

Safety and immunogenicity of two recombinant DNA COVID-19 vaccines containing the coding regions of the spike or spike and nucleocapsid proteins: an interim analysis of two open-label, non-randomised, phase 1 trials in healthy adults

스파이크 또는 스파이크 및 뉴클레오캡시드 단백질의 코딩 영역을 포함하는 2개의 재조합 DNA COVID-19 백신의 안전성 및 면역원성: 건강한 성인을 대상으로 한 2개의 공개 라벨, 비무작위, 1상 시험에 대한 중간 분석

Clinical Trial

Published on 2022-03-012022-09-11
Journal: The Lancet. Microbe
[Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료기술, 치료법,

[키워드] adverse event adverse events analysed Antibody Response blood sample Blood samples coding region collected COVID-19 vaccine development DNA DNA vaccine domain dose of vaccination doses drug energy ENhance enrolled fatigue first vaccination group healthy hospital humoral immunogenicity individuals induce intention-to-treat population interim analysis intervals intramuscularly Mild Ministry of Health moderate neutralising antibody response nucleocapsid nucleocapsid protein Open-label participant Participants Phase 1 phase 1 trial Plasmid plasmid DNA positive Primary outcome RBD recombinant DNA Registered reported Safe Safety SARS-CoV-2 SARS-CoV-2 spike protein SARS-CoV-2-specific T-cell responses Science screened second dose secondary outcome Serological testing South Korea Spike protein T-cell responses tested the RBD the SARS-CoV-2 the spike protein the vaccines Trade treatment-emergent adverse event Trial trial participant trials vaccination Vaccine vaccine dose vaccine immunogenicity Welfare were excluded
[DOI] 10.1016/S2666-5247(21)00358-X PMC 바로가기 [Article Type] Clinical Trial