safety profile – Page 14 – Communicable Diseases Research

Pentoxifylline effects on hospitalized patients with COVID19: A randomized, double-blind clinical trial

COVID19로 입원한 환자에 대한 Pentoxifylline 효과: 무작위, 이중 맹검 임상 시험

Randomized Controlled Trial

Published on 2021-12-012022-09-11
Journal: International immunopharmacology [Category] SARS, 임상, 치료제,

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial

건강한 소아 및 청소년을 대상으로 한 불활성화 SARS-CoV-2 백신(CoronaVac)의 안전성, 내약성 및 면역원성: 이중 맹검, 무작위, 대조, 1/2상 임상 시험

Clinical Trial

Published on 2021-12-012022-09-12
Journal: The Lancet. Infectious Diseases [Category] MERS, SARS, 임상, 진단, 치료기술,

[키워드] 95% CI Adverse reaction age All participants aluminum Antibody Response Antibody titre assigned Beijing block Block randomisation center children China Chinese clinical trial Control CoronaVac COVID-19 pandemic COVID-19 vaccine detectable development dose dose-escalation double-blind Endpoint enrolled geometric mean titre groups healthy children Humoral response hydroxide inactivated individual Infection injection injection site Intramuscular injection investigators Laboratory live SARS-CoV-2 Mild moderate MOST neutralising antibody occurred Pain participant Participants per-protocol population phase 1 trial Pneumonia prevention primary immunogenicity Program randomised Randomly receive Registered reported Safe Safety safety population safety profile SARS-CoV-2 SARS-CoV-2 vaccine Science second dose Serious Adverse Event Seroconversion seroconversion rate severity significant difference Support technology three group Tolerability vaccination Vaccine were excluded
[DOI] 10.1016/S1473-3099(21)00319-4 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

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

Efficacy, Safety and Future Perspectives of JAK Inhibitors in the IBD Treatment

Review

Published on 2021-11-302022-10-30
Journal: Journal of Clinical Medicine [Category] COVID-19,

Mild Adverse Events of Sputnik V Vaccine in Russia: Social Media Content Analysis of Telegram via Deep Learning

Original Paper

Published on 2021-11-292022-10-30
Journal: Journal of Medical Internet Research [Category] COVID-19, MERS, SARS,

[키워드] addition Administered Adverse adverse event adverse events AEs age analyzed applied average caused chills chose clinical trial co-occurrence collected comparable concerning conducted content corpus COVID-19 COVID-19 vaccines database dataset deep deep learning diarrhea doses drugs elderly Euclidean distance fatigue Fever first dose frequencies Gam-COVID-Vac Gender headache information Insomnia Lancet learning lymph node enlargement media men Messenger RNA Mild nausea/vomiting objective Pain Pearson correlation performed Phase 3 pruritus reported representation Result resulting Russian language safety profile SARS-CoV-2 second dose sequence significantly more social media Sputnik V Symptom systemic AE Telegram transformer Trial unique vaccination Vaccine vaccine safety Vaccines vector
[DOI] 10.2196/30529 PMC 바로가기 [Article Type] Original Paper

JAK-STAT Pathway: A Novel Target to Tackle Viral Infections

Review

Published on 2021-11-272022-10-28
Journal: Viruses [Category] COVID-19,

COVID-19 Vaccination in Patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: Safety Profile and Reasons for Opting against Vaccination

Article

Published on 2021-11-252022-10-28
Journal: Vaccines [Category] COVID-19,

[키워드] adverse event AEs age Anxiety approved arterial chronic chronic thromboembolic pulmonary hypertension COVID-19 COVID-19 vaccination COVID-19 vaccine cross-sectional disease examined Factor fatigue female Fever first dose General population headache identify impacted incidence of COVID-19 Infection injection median age mortality rate much higher myalgia older patient PAH Pain Patient patients post-vaccination symptoms profile pulmonary pulmonary arterial hypertension pulmonary hypertension reason regression analysis reported Safe Safety safety profile second dose thromboembolic Univariate analysis vaccinated against COVID-19 vaccination vaccination against COVID-19
[DOI] 10.3390/vaccines9121395 PMC 바로가기 [Article Type] Article

A Mycobacteriophage-Based Vaccine Platform: SARS-CoV-2 Antigen Expression and Display

Article

Published on 2021-11-232022-10-29
Journal: Microorganisms [Category] COVID-19,

A COVID-19 peptide vaccine for the induction of SARS-CoV-2 T cell immunity

SARS-COV-2 T 세포 면역의 유도를위한 COVID-19 펩티드 백신

Clinical Trial

Published on 2021-11-232022-08-13
Journal: Nature [Category] MERS, SARS, 변종, 임상, 치료기술, 치료법, 치료제,

[키워드] All study participants analysed Analysis approved B cell CD4 CD8 composed conducted CoVac-1 COVID-19 deficiency end point Epitopes event Follow-up granuloma IFNγ Immunity immunogencity immunogenicity induce Local Mild Montanide ISA51 multifunctional Open-label open-label trial participant Patient peptide Peptide vaccines peptide-based peptide-based vaccine peptides Phase I Phase I trials primary end point reactogenicity receptor safety profile SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 vaccine SARS-CoV-2 variant Serious Adverse Event Serious Adverse Events Study participants surpassed systemic reactogenicity T cell T cell epitope T cell epitopes T cell response T cell responses T cells T helper Toll-like receptor Trial vaccination Vaccine Vaccines variant Viral viral infection viral infections Viral protein Viral proteins
[DOI] 10.1038/s41586-021-04232-5 PMC 바로가기 [Article Type] Clinical Trial