Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial2019년 코로나바이러스 질환 입원 환자에서 사릴루맙의 효능 및 안전성: 무작위 임상 시험Randomized Controlled Trial Published on 2022-08-242022-09-11 Journal: Clinical Infectious Diseases: An Official Publicat [Category] 임상, 진단, [키워드] 95% CI 95% confidence interval adaptive adults hospitalized Analysis anti-IL-6R monoclonal antibody baseline benefit clinical clinical status coronavirus disease Coronavirus disease 2019 Corticosteroid Corticosteroids corticosteroids) COVID-19 Critical death double-blind Efficacy Efficacy and safety evaluated hazard ratio Hospitalized hospitalized patient hospitalized patients interleukin interleukin-6 interleukin-6 receptor intravenous mechanical ventilation Meta-analysis monoclonal antibodies Patient patients randomized Phase 2 phase 2/3 Phase 3 Placebo placebo-controlled trial Platform trial Post hoc analyses post-hoc analysis primary analysis population Primary outcome proportion Randomized receiving Relative risk risk risk difference Safety sarilumab therapy treated Treatment Trial with COVID-19 [DOI] 10.1093/cid/ciac153 PMC 바로가기 [Article Type] Randomized Controlled Trial
A randomised, double-blind, placebo-controlled, multicentre clinical trial of AZD1656 in diabetic patients hospitalised with COVID-19: The ARCADIA Trial – implications for therapeutic immune modulationResearch article Published on 2022-08-182022-10-05 Journal: EClinicalMedicine [Category] 바이오마커, 변종, 임상, [키워드] 1:1 Activation Adaptive immune response addition adverse event ARCADIA assigned AZD1656 Clinical improvement clinical trial Complete COVID-19 cytokine Czech Republic Day death decrease diabetes diabetic patient diabetic patients dose double-blind duration of hospitalisation Efficacy Excalibur False positive finding Full Analysis Set funding Glucokinase activator group homeostatic hospital hospital discharge hospitalised identify immune Immune cell immune modulation immune response Immunochemistry immunomodulatory effect Immunophenotyping implication indicated Innovation investigated involved less Medicine multicentre nine no difference Patient phase Phase 2 Placebo placebo-controlled placebo-controlled clinical trial primary analysis primary endpoint pro-inflammatory randomised Randomly receive recruited reduction in Registered regulatory T cells required risk Romania SARS-CoV-2 screened statistically significant difference suggested Tablet the placebo group therapeutic therapeutic effect treated Treatment treatment allocation Tregs Trial usual care with COVID-19 [DOI] 10.1016/j.eclinm.2022.101604 [Article Type] Research article
Clinical grade ACE2 as a universal agent to block SARS-CoV-2 variantsSARS-CoV-2 변종을 차단하는 범용 약제로서의 임상 등급 ACE2Article Published on 2022-08-082022-09-11 Journal: EMBO Molecular Medicine [Category] COVID19(2023년), SARS, 변종, 진단, [키워드] ACE2 Alpha analyzed Beta binding affinity caused clinical clinical trial COVID-19 Delta develop Efficacy epithelial cell epithelial cells Gamma human lung human lung epithelial cells independent Infection inhibit inhibited neutralized neutralizing antibody omicron Phase 2 principle proof reduced SARS-CoV-2 isolates SARS-CoV-2 variant SARS-CoV-2 variants several variant several variants soluble ACE2 strain tested therapeutic Therapeutic strategies therapeutic strategy These data Treatment Vaccine variants variants of concern VeroE6 cell VeroE6 cells VoC [DOI] 10.15252/emmm.202115230 PMC 바로가기 [Article Type] Article
rVSV-ΔG-SARS-CoV-2-S vaccine: repeated intramuscular (IM) toxicity, local tolerance, immunogenicity and biodistribution study in NZW rabbitsrVSV-ΔG-SARS-CoV-2-S 백신: NZW 토끼에서 반복되는 근육내(IM) 독성, 국소 내성, 면역원성 및 생체 분포 연구Article Published on 2022-08-012022-09-11 Journal: Archives of Toxicology [Category] COVID19(2023년), MERS, SARS, 비임상, 진단, 치료기술, [키워드] Administered animals antibody antibody levels Antibody titers Antigen assigned binding biodistribution biodistribution study body temperature body weight breath C-reactive protein change Clinical pathology Clinical signs clinical trial clinical trials correlated COVID-19 detection elicited evaluate Express followed by Gross High-dose high-dose group histopathological iliac lymph node immunogenicity inflammatory reaction injection intervals intramuscular intramuscularly Local local reactions Lymph node mesenteric lymph nodes Necrosis Neutralizing antibodies Neutralizing antibody titer neutralizing antibody titers New Nonclinical ophthalmology pathology Phase 2 platform Reactions repeated RNA Safe Safety SARS-CoV-2 SARS-CoV-2-S significant increase spleen stomatitis supported systemic the vaccine Tolerance Toxicity two group two groups Urinalysis vaccination Vaccine vaccine doses Vector-based vaccine vesicular stomatitis vesicular stomatitis virus Viremia VSV was performed [DOI] 10.1007/s00204-022-03302-5 PMC 바로가기 [Article Type] Article
Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trialChAdOx1 nCoV-19 또는 BNT162b2 2회 접종 및 BNT162b2(COV-BOOST) 3차 접종 후 4차 접종으로 제공된 BNT162b2 및 mRNA-1273 COVID-19 백신의 안전성, 면역원성 및 반응성: 다기관, 맹검, 단계 2, 무작위 시험Clinical Trial Published on 2022-08-012022-09-11 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] 1:1 95% CI adverse event All participants analysed anti-spike protein IgG assigned blinded block size BNT162b2 boost booster Booster vaccine cellular Cellular and humoral immunity Cellular immune response ChAdOx1 nCoV-19 computer-generated Concentration Controlled trial country COV-BOOST COVID-19 COVID-19 vaccine COVID-19 vaccines dose doses Effectiveness ELISA ELISPOT Endpoint enrolled fatigue female Fold change Fold changes force geometric geometric mean groups Humoral immunity immunogenicity Intramuscular injection IQR ISRCTN Laboratory Local male median age median interval Moderna modified intention-to-treat mRNA mRNA-1273 mRNA-1273 booster mRNA-1273 COVID-19 vaccine multicentre of BNT162b2 outcome participant peak per-protocol population Pfizer-BioNTech Phase 2 random randomisation list randomised controlled trial Randomised trial Randomly reactogenicity receive Registered reported representing response Safety SARS-CoV-2 screened Serious Adverse Event seronegative participant seronegative participants serostatus Seven significant increase statistician T-cell Response T-cell responses Task Force the vaccine the vaccines titre treatment allocation Trial upper arm Vaccine variant were assessed wild-type [DOI] 10.1016/S1473-3099(22)00271-7 PMC 바로가기 [Article Type] Clinical Trial
Safety and immunogenicity of the FINLAY-FR-1A vaccine in COVID-19 convalescent participants: an open-label phase 2a and double-blind, randomised, placebo-controlled, phase 2b, seamless, clinical trialCOVID-19 회복기 참가자에 대한 FINLAY-FR-1A 백신의 안전성 및 면역원성: 공개 라벨 2a상 및 이중 맹검, 무작위 배정, 위약 대조, 2b상, 심리스, 임상 시험Clinical Trial Published on 2022-08-012022-09-11 Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 변종, 임상, [키워드] 95% CI adverse event All participants Alpha anti-RBD antibody assigned Asymptomatic Beta clinical clinical trial clinical trials Complete control group control groups convalescent convalescent individual convalescent individuals COVID-19 criteria Cuba defined delta variant Delta variants dimeric double-blind education elicited ELISA Endpoint enrolled Environment evaluate evaluated experimental group first stage geometric mean geometric mean titre geometric mean titres greater hematology ICTRP IgG antibodies immune response immunogenicity immunology increase in injected injection injection site Intervention intervention group Mild minor Moderate COVID-19 natural immunity Negative PCR neutralisation test neutralising antibody Occurrence Open-label Pain participant Participants PCR test per-protocol population Phase 1 Phase 2 Placebo placebo group placebo-controlled prevaccination Primary outcome Primary outcomes Public randomised Randomly Receptor binding domain recruited Registered registry reported Safety safety analysis safety population safety profile SARS-CoV-2 Science seamless secondary Secondary endpoints Serious Adverse Event Serious Adverse Events seroconversion rate sexual single dose stages study population technology the placebo group titre Trial two groups vaccination Vaccine vaccine immunogenicity Virus neutralisation Volunteer was done WHO-ICTRP [DOI] 10.1016/S2213-2600(22)00100-X PMC 바로가기 [Article Type] Clinical Trial
Long-COVID: Phase 2 of the COVID-19 PandemicEditorial Published on 2022-08-012022-10-05 Journal: The American journal of medicine [Category] SARS, 변종, [키워드] COVID-19 Phase 2 [DOI] 10.1016/j.amjmed.2022.07.017 [Article Type] Editorial
Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection: A Phase 2 Dose-Ranging Randomized Clinical TrialSARS-CoV-2 감염 외래 환자에서 Casirivimab과 Imdevimab COVID-19 항체 조합의 바이러스학적 효능: 2상 용량 범위 무작위 임상 시험Clinical Trial Published on 2022-08-012022-09-12 Journal: JAMA Network Open [Category] SARS, 임상, 진단, [키워드] 95% CI Administered age Asymptomatic average baseline Casirivimab clinical collected COVID-19 death dose double-blind Efficacy efficacy analysis greater Hispanic Hospitalization hypersensitivity reactions Imdevimab in viral intravenous mean difference monoclonal antibody combination outcome Outpatient parallel-group participant Participants Patient patients Phase 2 Phase 3 Placebo placebo-controlled primary end point Randomized randomized clinical trial ranged Reactions reduced reduction reported risk factor SARS-CoV-2 SARS-COV-2 infection Serious Adverse Event seronegative severe COVID-19 study drug Subcutaneous symptomatic symptomatic patient The United States Treatment Viral load were excluded white [DOI] 10.1001/jamanetworkopen.2022.25411 PMC 바로가기 [Article Type] Clinical Trial
Plant formulation ATRICOV 452 in improving the level of COVID-19 specific inflammatory markers in patientsResearch article Published on 2022-08-012022-10-05 Journal: Contemporary Clinical Trials Communications [Category] 바이오마커, 신약개발, 임상, [키워드] adverse event assigned Care clinical trial conducted COVID-19 COVID-19 patient CTRI determine dose dropped effective Efficacy evaluate faster Frequency healthcare healthy healthy volunteer hospital Human Importance IMPROVE Inflammatory marker inflammatory markers objective organ system oxygen Patient phase Phase 1 Phase 2 phase 2 trial Placebo plant Plant formulation (ATRICOV 452) primary analysis population randomization receive reduce Registration Result Safe setting Standard of care Support therapeutic intervention Tolerability treatment group Trial Volunteer [DOI] 10.1016/j.conctc.2022.100961 [Article Type] Research article
Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trialsAd26.COV2.S의 1회 투여에 의해 유도된 지속적인 항체 반응 및 부스팅 후 상당한 증가: 2건의 무작위 임상 시험Article Published on 2022-07-302022-09-11 Journal: Vaccine [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] Ad26 Ad26.COV2.S age analyzed anti-SARS-CoV-2 antibodies anti-SARS-CoV-2 antibody antibody Antibody Response Beta Beta variant binding binding antibodies binding antibody boost booster booster dose booster doses Cohort COV2.S COVID-19 determined by dose double-blind effective elicited enrolled enzyme enzyme-linked immunosorbent enzyme-linked immunosorbent assay evaluated followed by groups Identifier immune memory immunization immunosorbent increase in initial magnitude Neutralization assay Neutralizing antibodies neutralizing antibody Neutralizing antibody response neutralizing antibody responses participant Phase 2 Placebo placebo-controlled pseudotyped Randomized randomized clinical trial response robust Single-dose trials vaccination Vaccine vaccine dose variant Viral viral particle Virus neutralization virus neutralization assay [DOI] 10.1016/j.vaccine.2022.05.047 PMC 바로가기 [Article Type] Article