Serious Adverse Events – Page 8 – Communicable Diseases Research

Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019

2019년 중증 코로나바이러스 질환을 앓고 있는 임산부에게 렘데시비르의 자비로운 사용

Article

Published on 2021-12-062022-09-11
Journal: Clinical Infectious Diseases: An Official Publicat [Category] SARS, 신약개발,

Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults

건강한 성인을 대상으로 한 비활성화된 중증 급성 호흡기 증후군 코로나바이러스 2 백신에 대한 무작위, 이중 맹검, 위약 대조 2상 시험

Clinical Trial

Published on 2021-12-062022-09-11
Journal: Clinical Infectious Diseases: An Official Publicat [Category] SARS, 임상, 진단, 치료기술,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Adverse reaction Adverse reactions anti-N antibodies anti-N antibody anti-S antibody clinical Controlled trial coronavirus coronavirus 2 dose double-blinded enrolled evaluated geometric mean geometric mean titer geometric mean titers GMT GMTs groups HD group healthy High dose immunization immunogenicity inactivated Inactivated SARS-CoV-2 vaccine medium dose neutralizing antibody Phase 2 phase 2 trial Randomized respiratory Safety safety analysis SARS-CoV-2 SARS-CoV-2 vaccine Serious Adverse Event Serious Adverse Events seroconversion rate seroconversion rates study period subject the vaccine Trial Vaccine
[DOI] 10.1093/cid/ciaa1703 PMC 바로가기 [Article Type] Clinical Trial

Antibody Response and Safety After mRNA-1273 SARS-CoV-2 Vaccination in Peritoneal Dialysis Patients – the Vienna Cohort

복막 투석 환자에서 mRNA-1273 SARS-CoV-2 백신 접종 후 항체 반응 및 안전성 – 비엔나 코호트

Immunology

Published on 2021-12-022022-09-12
Journal: Frontiers in Immunology [Category] SARS, 진단,

[키워드] acute respiratory syndrome adverse event analyzed anti-SARS-CoV-2 Anti-SARS-CoV-2 S antibody Antibody Response Antibody titer Antibody titers Clinical course Cohort coronavirus COVID-19 dialysis dose early immune response examined Factor fatigue Fever first dose headache Hemodialysis high risk incidence Infection injection IQR joint Local Lower median Moderna mRNA-1273 mRNA-1273 vaccine mRNA-based myalgia occurred Pain Patient patients Peritoneal dialysis Regression model reported response Result retrospective Safety SARS-CoV-2 SARS-CoV-2 S score second dose Serious Adverse Events seroconversion rate seroconverted severity significantly spike systemic systemic AE systemic side effect vaccination Vaccine Vienna
[DOI] 10.3389/fimmu.2021.780594 PMC 바로가기 [Article Type] Immunology

REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19

COVID-19 외래 환자의 REGEN-COV 항체 조합 및 결과

Clinical Trial

Published on 2021-12-022022-09-11
Journal: The New England Journal of Medicine [Category] 변종, 임상, 진단, 치료제,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adaptive adverse event Analysis assigned baseline Casirivimab Combination Comparisons coronavirus coronavirus disease Coronavirus disease 2019 death dose end point End points evaluated faster GRADE groups Hierarchical Hospitalization Imdevimab in viral in vitro infusion intravenous less log mean difference median time monoclonal antibodies monoclonal antibody occurred outcome Outpatient outpatients Patient Phase 3 Placebo placebo group portion randomization Randomly reaction receive reduced REGEN-COV Regeneron Pharmaceutical Regeneron Pharmaceuticals Relative risk resolution of symptom resolution of symptoms resolved respiratory risk risk factor Risk factors risk reduction Safety SARS-CoV-2 SARS-CoV-2 viral load Serious Adverse Events serum serum antibody severe disease subgroups Symptom the patient the placebo group the SARS-CoV-2 Trial variants of concern Viral Viral load was used
[DOI] 10.1056/NEJMoa2108163 PMC 바로가기 [Article Type] Clinical Trial

Impact of prior infection status on antibody response to the BNT162b2 mRNA COVID-19 vaccine in healthcare workers at a COVID-19 referral hospital in Milan, Italy

이탈리아 밀라노의 COVID-19 위탁 병원에서 의료 종사자의 BNT162b2 mRNA COVID-19 백신에 대한 항체 반응에 대한 이전 감염 상태의 영향

Article

Published on 2021-12-022022-09-11
Journal: Human vaccines & immunotherapeutics [Category] SARS, 진단, 치료기술,

[키워드] 95% CI adjusted odds ratio anti-S IgG anti-SARS-CoV-2 Antibody Response BNT162b2 BNT162b2 mRNA BNT162b2 vaccine COVID-19 COVID-19 vaccine detectable dose effective elapsed enrolled Fever first dose HCW HCWs healthcare healthcare worker Healthcare workers hospital humoral Humoral response IgG levels Impact Infection Italy Mild mild to moderate moderate mRNA vaccine naïve subjects occurred of BNT162b2 reactogenicity receive reported risk SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 vaccination Serious Adverse Event Serious Adverse Events serological serological response Side effect single dose spike IgG subject subjects the median the vaccine Vaccine
[DOI] 10.1080/21645515.2021.2002639 PMC 바로가기 [Article Type] Article

Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial

입원한 성인 COVID-19(COV-BARRIER) 치료를 위한 바리시티닙의 효능 및 안전성: 무작위, 이중 맹검, 병행군, 위약 대조 3상 시험

Clinical Trial

Published on 2021-12-012022-09-11
Journal: The Lancet. Respiratory Medicine [Category] Fulltext, SARS, 임상, 치료법, 치료제,

[키워드] 1:1 95% CI Abstract addition all-cause mortality anti-inflammatory properties antivirals Asia assigned available data Baricitinib baseline Care Combination company Corticosteroids country death defined Dexamethasone Disease progression dose double-blind Efficacy and safety enrolled Europe evaluate event exploratory Follow-up French frequencies Frequency hazard ratio High-flow oxygen hospitalised inhibitor intention-to-treat population Invasive mechanical ventilation Janus kinase Japanese Lilly material Mortality non-invasive ventilation North America Odds ratio oxygen parallel-group participant Participants Phase 3 phase 3 trial Placebo placebo group placebo-controlled placebo-controlled trial prevented primary endpoint progressed proportion randomised Randomly receive receiving reduced reduction in Registered Remdesivir risk risk difference safety analyses safety analysis safety population safety profile secondary endpoint selective Serious Adverse Event Serious Adverse Events serious infection serious infections South America Spanish Standard Standard of care study drug systemic corticosteroid systemic corticosteroids the placebo group the primary endpoint thromboembolic translation Treatment two groups venous thromboembolic were assessed with COVID-19
[DOI] 10.1016/S2213-2600(21)00331-3 PMC 바로가기 [Article Type] Clinical Trial

An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19

코로나19로 입원한 환자를 대상으로 한 로피나비르/리토나비르, 로피나비르/리토나비르 + IFN-β-1a 및 히드록시클로로퀸의 효과에 대한 공개 무작위 대조 시험

Clinical Trial

Published on 2021-12-012022-09-11
Journal: Clinical microbiology and infection : the official [Category] 임상, 치료제,

[키워드] 95% confidence interval 95%CI acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adaptive adjusted odds ratio adults hospitalized age analyses Arm ARMS clinical status conducted Controlled trial coronavirus coronavirus 2019 disease COVID-19 evaluated expected hospitalized patient Hydroxychloroquine Inpatient intention-to-treat population Interferon β-1a IQR Lopinavir LOPINAVIR AND RITONAVIR Lopinavir/ritonavir male median age multicentre no significant effect not improved Occurrence Open-label Ordinal Scale outcome oxygen participant pharmacokinetic plasma concentration Primary outcome quantification Randomized Randomized controlled trial regimen Remdesivir respiratory specimen respiratory specimens respiratory tract specimens Ritonavir SARS-CoV-2 SARS-CoV-2 clearance secondary Secondary outcomes Serious Adverse Event Serious Adverse Events seven-point ordinal scale severe acute respiratory syndrome Coronavirus severe disease significant effect significantly higher solidarity Solidarity trial Standard of care the median the WHO treat Treatment Trial trough ventilatory support Virological with COVID-19
[DOI] 10.1016/j.cmi.2021.05.020 PMC 바로가기 [Article Type] Clinical Trial

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

Single-dose oral ivermectin in mild and moderate COVID-19 (RIVET-COV): A single-centre randomized, placebo-controlled trial

Randomized Controlled Trial

Published on 2021-12-012022-10-05
Journal: Journal of infection and chemotherapy : official j [Category] SARS, 신약개발, 임상,

[키워드] acute respiratory syndrome administration Analysis antiparasitic drug Arm assigned Coronavirus-2 COVID-19 dose double blind Efficacy enrolment hospitalized patient in viral In-vitro intention-to-treat population Intervention Ivermectin Mild Mild-to-moderate Moderate COVID-19 modified intention-to-treat negativity occurred outcome Patient patients randomized Placebo placebo-controlled trial positive RT-PCR Primary outcome Randomized Randomized controlled trial reducing RT-PCR Safety SARS-CoV-2 Serious Adverse Event Serious Adverse Events significantly Single-dose statistical significance treating COVID-19 Viral load were assessed
[DOI] 10.1016/j.jiac.2021.08.021 PMC 바로가기 [Article Type] Randomized Controlled Trial

Analysis of antibody responses after COVID-19 vaccination in liver transplant recipients and those with chronic liver diseases

간 이식 환자 및 만성 간 질환 환자의 코로나19 백신 접종 후 항체 반응 분석

Article

Published on 2021-12-012022-09-12
Journal: Journal of hepatology [Category] MERS, SARS, 진단,

[키워드] adjusted antibody Antibody Response chronic liver disease cirrhosis CLD Clinical efficacy COVID-19 vaccination COVID-19 vaccine defined dose Efficacy enrolled evaluate Factors immune response Immunocompromised Immunocompromised patient Immunosuppression Immunosuppressive medication Johnson & Johnson liver liver transplant median titer medication Moderna mRNA vaccine multivariable analysis Patient patient population patients performed Pfizer Poor Prospective Study recipient recipients responses SARS-CoV-2 SARS-CoV-2 vaccination Serious Adverse Events single dose Spike protein Trial U/mL undetectable vaccination Vaccine
[DOI] 10.1016/j.jhep.2021.08.008 PMC 바로가기 [Article Type] Article