TEAE – 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

Astodrimer sodium antiviral nasal spray for reducing respiratory infections is safe and well tolerated in a randomized controlled trial

호흡기 감염 감소를 위한 아스토드리머 나트륨 항바이러스 비강 스프레이는 무작위 대조 시험에서 안전하고 내약성이 우수합니다.

Randomized Controlled Trial

Published on 2022-06-172022-09-11
Journal: Scientific Reports
[Category] COVID19(2023년), SARS, 임상, 치료기술, 치료제,

[키워드] absorbed Absorption Administered administration adverse event All participants Antiviral applied clinical clinical investigation clinical trial clinically Cohort Community community acquired dendrimer double-blinded Effects examination finding examination findings exploratory exposure to followed by four times daily Frequency healthy volunteer help in vitro Infection initial intensity Intensive Mild nasal Nasal cavity nasal mucosa Nasal spray New nostril occurred other respiratory virus Other respiratory viruses participant Placebo placebo-controlled primary endpoint product Randomized Randomized controlled trial receiving reduce reducing Registered registry respiratory infection respiratory virus Respiratory virus infections respiratory viruses Safe safety population SARS-CoV-2 serious AEs severity shown sodium spray Spread systemically TEAE TEAEs Tolerability Treatment Trial registration utility vaginal mucosa Viral load virucidal Withdrawal
[DOI] 10.1038/s41598-022-14601-3 PMC 바로가기 [Article Type] Randomized Controlled 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 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

A phase I, first-in-human, randomized dose-escalation study of anti-activated factor XII monoclonal antibody garadacimab

항 활성화 인자 XII 단일 클론 항체 garadacimab의 I 상, 최초 인간, 무작위 용량 증량 연구

Clinical Trial

Published on 2022-03-012022-09-12
Journal: Clinical and translational science
[Category] MERS, 임상, 진단,

First-in-Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID-19

COVID-19로 입원한 환자의 무작위 시험에서 밤라니비맙에 대한 인간 최초 연구

Randomized Controlled Trial

Published on 2021-12-012022-09-11
Journal: Clinical Pharmacology and Therapeutics
[Category] MERS, 신약개발, 임상, 진단, 치료제,

[키워드] administration adverse event adverse events analyses attachment bamlanivimab block clinical trials coronavirus disease Coronavirus disease 2019 COVID-19 Critical death dose double-blind group half-life hospitalized patient hospitalized patients human cells increases in initial lead linear monoclonal antibody Neutralizing pandemic Patient patients hospitalized pharmacokinetic Placebo placebo-controlled provided Randomized respiratory safety profile SARS-CoV-2 Secondary objectives Serious Adverse Event Serious Adverse Events Severe acute respiratory syndrome severity single ascending dose single dose Sponsor Support TEAE TEAEs Therapeutic benefit Therapeutics Tolerability treatment-emergent adverse event Trial with COVID-19
[DOI] 10.1002/cpt.2405 PMC 바로가기 [Article Type] Randomized Controlled Trial

Phase I study in healthy participants to evaluate safety, tolerability, and pharmacokinetics of inhaled nezulcitinib, a potential treatment for COVID-19

Clinical Trial

Published on 2021-11-012022-10-05
Journal: Clinical and translational science
[Category] 임상,

Tolerability, Safety, Pharmacokinetics, and Immunogenicity of a Novel SARS-CoV-2 Neutralizing Antibody, Etesevimab, in Chinese Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study

중국의 건강한 성인을 대상으로 한 새로운 SARS-CoV-2 중화 항체인 Etesevimab의 내약성, 안전성, 약동학 및 면역원성: 무작위, 이중 맹검, 위약 대조, 인간 최초의 1상 연구

Clinical Trial

Published on 2021-07-162022-09-12
Journal: Antimicrobial Agents and Chemotherapy
[Category] SARS, 임상, 진단,

[키워드] acute respiratory syndrome administration Adults adverse event anti-SARS-CoV-2 Anti-spike anti-spike neutralizing antibodies Characteristics Chinese Cohort cohorts comparable coronavirus COVID-19 distribution dose double-blind elimination half-life enrolled etesevimab healthy healthy volunteer immunogenicity intravenous dose JS016 LY3832479 monoclonal antibody Neutralizing Neutralizing antibodies not differ novel participant pharmacokinetics pharmacokinetics. Phase 1 phase 1 study Placebo placebo-controlled profile Randomized receive Registered Safety SARS-CoV-2 single dose Spread TEAE TEAEs the placebo group Tolerability Treatment
[DOI] 10.1128/AAC.00350-21 PMC 바로가기 [Article Type] Clinical Trial