study drug – 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,

Dipeptidyl peptidase-1 inhibition in patients hospitalised with COVID-19: a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial

Article

Published on 2022-09-022022-10-06
Journal: The Lancet. Respiratory Medicine
[Category] 진단,

[키워드] 1:1 Activation adjusted odds ratio age analysis assigned block brensocatib clinical status common adverse event criteria death disorder dose double-blind enrolment enzyme hospital Hospital admission hospitalised IMPROVE in both group Infection infections inhibitor intention-to-treat population investigated investigator involved ISRCTN medication multicentre neutrophil Older outcome parallel-group participant pathogenesis of COVID-19 Patient patients Placebo placebo-controlled trial Primary outcome random random assignment randomised Randomly receive Registered reported required responsible risk factor safety population serine protease serine proteases severe disease stratified study drug supported the placebo group therapy Treatment Trial university web-based randomisation system were excluded WHO ordinal scale with COVID-19
[DOI] 10.1016/S2213-2600(22)00261-2 PMC 바로가기 [Article Type] Article

Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection: A Phase 2 Dose-Ranging Randomized Clinical Trial

SARS-CoV-2 감염 외래 환자에서 Casirivimab과 Imdevimab COVID-19 항체 조합의 바이러스학적 효능: 2상 용량 범위 무작위 임상 시험

Clinical 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

Network approaches for modeling the effect of drugs and diseases

약물 및 질병의 영향 모델링을 위한 네트워크 접근 방식

Review

Published on 2022-07-182022-09-11
Journal: Briefings in Bioinformatics
[Category] COVID19(2023년), SARS, 신약개발,

Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Clinical Trial

Published on 2022-07-082022-10-05
Journal: The Lancet. Respiratory Medicine
[Category] 임상, 진단, 치료법,

[키워드] 1:1 addition adverse event analysis assigned baseline Cohort Complete COVID-19 cumulative defined double-blind Europe extracorporeal membrane oxygenation finding Follow-up funding hazard ratio hospital discharge hospitalised hypothesised IMPROVE incidence infused intravenous Invasive mechanical ventilation investigators modified intention-to-treat monoclonal antibody combination Mortality neutralising NIH occurred operation Organ failure outcome participant Patient Phase 3 phase 3 trial Placebo placebo group placebo-controlled trial Primary outcome randomised Randomly receive receiving Registered Remdesivir renal replacement therapy Result Safe seronegative Singapore speed standard care study drug Study participants Support sustained Symptom the placebo group therapy Treatment Uganda USA were excluded with COVID-19
[DOI] 10.1016/S2213-2600(22)00215-6 [Article Type] Clinical Trial

Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial

6~17세 어린이 대상 ChAdOx1 nCoV-19(AZD1222) 백신의 안전성 및 면역원성: 2상 단일 맹검, 무작위, 대조 시험인 COV006의 예비 보고서

Clinical Trial

Published on 2022-06-112022-09-11
Journal: Lancet (London, England)
[Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료법,

[키워드] 95% CI administration Adults adverse event adverse events age All participants anti-SARS-CoV-2 IgG antibody Antibody titre antibody titres arbitrary unit assigned AstraZeneca AZD1222 baseline capsular Cellular responses ChAdOx1 ChAdOx1 nCoV-19 children chronic respiratory conditions Concentration Controlled trial COVID-19 COVID-19 vaccine COVID-19 vaccines Cutoff Department dose doses Efficacy enrolled Fever first dose first vaccination four group four groups geometric geometric mean geometric mean ratios Geometric means group half-maximal inhibitory concentration Humoral response humoral responses immune response immune responses immunogenic immunogenicity in some intramuscular dose introduced investigators ISRCTN Laboratory laboratory-confirmed Laboratory-confirmed COVID-19 Local nucleocapsid protein Pain and tenderness participant Participants peaked Phase 2 phase 3 study preliminary report Primary outcome prime and boost raised randomised Randomly receive receiving recruitment Registered remained reported resolved respiratory response Safety safety population SARS-CoV-2 second dose second vaccination secondary outcome Serious Adverse Event Serious Adverse Events seronegative seronegative participant seronegative participants seropositive serostatus single-blind stratified study drug study groups tenderness Tolerability treatment allocation Trial vaccination Vaccine Viral viral particle were recorded
[DOI] 10.1016/S0140-6736(22)00770-X PMC 바로가기 [Article Type] Clinical Trial

Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial

Clinical Trial

Published on 2022-06-072022-10-05
Journal: The Lancet. Respiratory Medicine
[Category] COVID19(2023년), SARS, 임상, 진단, 치료법, 치료제,

[키워드] 1:1 95% CI administration Adverse age Antigen assigned AstraZeneca block sizes blocked clinical clinical evaluation clinically collected conducted Course COVID-19 COVID-19 vaccination death dose double-blind Efficacy enrolled enrolment Europe evaluate event Fever finding for inclusion funding individual intramuscular intramuscular injections investigators involved Japan laboratory-confirmed SARS-CoV-2 infection Latin America less Mild moderate Moderate COVID-19 monoclonal antibody combination non-hospitalised occurred Older outcomes participant Phase 3 Placebo placebo-controlled study placebo-controlled trial prevent disease progression primary endpoint progression provided randomisation randomised Randomly receive Registered required respiratory tract risk reduction RT-PCR scale severe COVID-19 severity specimen Sponsor statistically stratified study drug Symptom symptom onset the disease the placebo group treating Treatment treatment group USA WHO
[DOI] 10.1016/S2213-2600(22)00180-1 [Article Type] Clinical Trial

Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses

코로나19 입원 환자를 위한 렘데시비르 및 기타 3가지 약물: WHO 연대 무작위 시험의 최종 결과 및 업데이트된 메타 분석

Meta-Analysis

Published on 2022-05-212022-09-11
Journal: Lancet (London, England)
[Category] 신약개발, 임상, 치료제,

[키워드] 1:1 allocation analysis antiviral drugs assigned average both groups Characteristics Compliance controls country COVID-19 COVID-19 diagnosis database death died discharge discharged disease severity drug drugs eligible patient Endpoint enrolled exclusion Final futility hospital Hospital mortality hospitalised hospitalised patient Hospitalised patients Hydroxychloroquine in both groups in-hospital mortality Inpatient Inpatients interferon ISRCTN Kaplan-Meier Local Lopinavir meta-analyses meta-analysis Meta-analysis Mortality mortality analysis mortality rate ratio no significant effect occurred Open-label outcome oxygen participant Patient patients patients with COVID-19 Placebo placebos primary endpoint progressed progression proportion randomisation Randomised trial Randomly rate ratio receive recruited regions Registered Remdesivir reported secondary Secondary endpoints solidarity Solidarity trial Standard of care study drug the WHO treatment period Trial Ventilated Ventilation were given WHO
[DOI] 10.1016/S0140-6736(22)00519-0 PMC 바로가기 [Article Type] Meta-Analysis

Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

COVID-19(TICO)로 입원한 성인을 위한 두 가지 중화 단일클론항체 치료제인 소트로비맙과 BRII-196과 BRII-198의 효능 및 안전성: 무작위 대조 시험

Randomized Controlled Trial

Published on 2022-05-012022-09-12
Journal: The Lancet. Infectious Diseases
[Category] COVID19(2023년), SARS, 임상, 진단,

[키워드] addition adjusted adjusted odds ratio Administered analyses analysis Analysis assigned Biotechnology Clinical outcome clinical recovery clinical trial Complication complications of COVID-19 COVID-19 COVID-19 symptom death defined Denmark died discharge double-blind Efficacy Efficacy and safety eligible enrolled enrolment female hospital hospitalised Inpatient Interim intravenously laboratory-confirmed SARS-CoV-2 infection male matching placebo median age modified intention-to-treat monoclonal antibody neutralising operation Organ failure outcome participant Patient Placebo placebo group placebo-controlled Poland Primary outcome randomisation randomised randomised controlled trial Randomly recruited Registered Serious Adverse Events significantly higher single dose speed Standard of care stratified study drug sustained Switzerland the placebo group Therapeutics Therapies therapy Treatment Trial USA were assessed with COVID-19
[DOI] 10.1016/S1473-3099(21)00751-9 PMC 바로가기 [Article Type] Randomized Controlled Trial

Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19: a summary of the protocol and analysis plan for a decentralized randomized controlled trial

COVID-19에 대한 비입원 외래 환자 창(TREAT NOW) 중 조기 항바이러스 요법의 시험: 분산형 무작위 대조 시험에 대한 프로토콜 및 분석 계획 요약

Article

Published on 2022-04-082022-09-11
Journal: Trials
[Category] COVID19(2023년), SARS, 임상, 치료제,

[키워드] adaptive analysis plan Antiviral approach assigned Asymptomatic blinded clinical trial collected coronavirus disease Coronavirus disease 2019 COVID-19 Data collection death dropped drug duration of symptoms effective Efficacy enrolled Enrollment evaluate Evidence heterogeneous outcome Hospitalization Hydroxychloroquine individual interactions Lopinavir Lopinavir/ritonavir majority Mild symptom mild symptoms novel occur outcome Outpatient outpatients participant Placebo placebo-controlled platform Population Pragmatic Prevent progression protocol Randomized randomized clinical trial Randomized controlled trial Randomly receive reduce remote Remote. Ritonavir severe disease study drug Study participants Symptom telephone therapy treat treated treatments for COVID-19 Trial window
[DOI] 10.1186/s13063-022-06213-z PMC 바로가기 [Article Type] Article