the placebo group – Page 11 – Communicable Diseases Research

Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials

성인에서 COVID-19에 대한 재조합 직렬 반복 이량체 RBD 기반 단백질 서브유닛 백신(ZF2001)의 안전성 및 면역원성: 2건의 무작위 배정, 이중 맹검, 위약 대조, 1상 및 2상 시험

Clinical Trial

Published on 2021-08-012022-09-12
Journal: The Lancet. Infectious Diseases [Category] MERS, SARS, 임상, 진단,

Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial

Randomized Controlled Trial

Published on 2021-08-012022-10-05
Journal: Clinical microbiology and infection : the official [Category] SARS, 임상,

[키워드] 1:1 95% CI acute respiratory syndrome adverse outcome age clinical evolution co-morbidity conducted coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patient death decrease determine disease double blind double-blind placebo-controlled trial end point End points France groups high risk Hydroxychloroquine hydroxychloroquine group ill patient intensive care intention-to-treat population interquartile range Invasive mechanical ventilation median age Mild Mild-to-moderate moderate Moderate COVID-19 Mortality multicentre occurred older patient Oxygen therapy pandemic Patient patients treated per day Placebo placebo-controlled positive primary end point randomization Randomized Randomized controlled trial receive receiving required risk risk factor SARS-CoV-2 RT-PCR test secondary severe acute respiratory syndrome coronavirus 2 supplemental oxygen the placebo group Trial two group viral shedding virological outcome were excluded worsening
[DOI] 10.1016/j.cmi.2021.03.005 PMC 바로가기 [Article Type] Randomized Controlled Trial

A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated

위약 그룹 백신 접종 후 COVID-19 백신 효과의 지속성을 평가하기 위한 지연 백신 접종 설계

Article

Published on 2021-08-012022-09-11
Journal: Annals of internal medicine [Category] SARS, 임상,

Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial

Covid-19 (Colcorona)를 가진 지역 사회 치료 환자를위한 콜히친 : 3 단계, 무작위, 이중 맹검, 적응 형, 위약 대조, 다중 센터 시험

Clinical Trial

Published on 2021-08-012022-08-13
Journal: The Lancet. Respiratory Medicine [Category] MERS, SARS, 임상,

[키워드] 1:1 absence adaptive adverse event allocation sequence Analysis anti-inflammatory agent assigned automated automated interactive web-response system benefit block size block sizes blocking schema Brazil Canada clinical criteria Colchicine colchicine group COLCORONA trial community-treated patient community-treated patients complications Composite computer-generated coronary disease COVID-19 COVID-19 complication COVID-19 complications COVID-19-related clinical event COVID-19-related clinical events COVID-19-related death death diagnosed diagnostic test diarrhoea double-blind double-blinded eligible enrolled excessive inflammation family finding foundation funding Gout Government Greece heart high-risk characteristic hospital Hospital admission intention-to-treat principle interactive web-response system IQR mandatory diagnostic test masked randomisation matching placebo median age Medicine Melinda Gate Melinda Gates Montreal Heart Institute multicentre occurred Odds ratio oral anti-inflammatory medication orally administered colchicine orally administered therapies orally administered therapy Participants Patient patients PCR testing PCR-confirmed PCR-confirmed COVID-19 PCR-positive community-treated patient PCR-positive community-treated patients per day Pericarditis Phase 3 Placebo placebo group placebo-controlled Pneumonia Prevent primary efficacy endpoint primary endpoint randomisation list randomised Randomly receive Registered Replication reported risk Safe School Serious Adverse Events Sophie South Africa Spain statistically significant the placebo group the primary endpoint treated Trial trial enrolment unmasked biostatistician USA Vital vital status was done with COVID-19
[DOI] 10.1016/S2213-2600(21)00222-8 PMC 바로가기 [Article Type] Clinical Trial

Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia

코로나19 폐렴으로 입원한 환자의 토파시티닙

Randomized Controlled Trial

Published on 2021-07-292022-09-11
Journal: The New England Journal of Medicine [Category] Fulltext, MERS, 임상, 치료제,

[키워드] 1:1 95% CI 95% confidence interval adverse event all-cause mortality assigned Brazil coronavirus disease Coronavirus disease 2019 COVID-19 pneumonia cumulative cumulative incidence death dose Efficacy and safety glucocorticoid Glucocorticoids hazard ratio hospital discharge Hospitalization Hospitalized incidence inhibitor Janus kinase Kinase inhibitor lower risk Mortality occurred Occurrence Ordinal Scale Patient patients hospitalized Pfizer Placebo placebo group Pneumonia Primary outcome randomization Randomly receive Respiratory failure risk risk ratio Serious Adverse Events STOP-COVID the patient the placebo group Tofacitinib
[DOI] 10.1056/NEJMoa2101643 PMC 바로가기 [Article Type] Randomized Controlled Trial

Effect of Canakinumab vs Placebo on Survival Without Invasive Mechanical Ventilation in Patients Hospitalized With Severe COVID-19: A Randomized Clinical Trial

심각한 COVID-19로 입원한 환자에서 침습적 기계 환기 없이 생존에 대한 카나키누맙 대 위약의 효과: 무작위 임상 시험

Clinical Trial

Published on 2021-07-202022-09-12
Journal: JAMA [Category] 임상, 진단, 치료제,

[키워드] 1:1 95% CI adverse event antibody assigned Biomarker Blood C-reactive protein canakinumab clinical Concentration conducted defined double-blind Effect Efficacy enrolled Europe evaluate ferritin hospital hospitalized patient hypoxia IMV Invasive mechanical ventilation likelihood Mechanical median age Mortality occurred Odds ratio outcome Patient patients hospitalized phase 3 trial Placebo placebo-controlled Pneumonia primary end point Primary outcome Randomized Randomly receive secondary severe COVID-19 significantly single intravenous infusion survival survived systemic hyperinflammation the placebo group The United States treated Treatment Trial with COVID-19 women
[DOI] 10.1001/jama.2021.9508 PMC 바로가기 [Article Type] Clinical Trial

Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey

비활성화된 전체 비리온 SARS-CoV-2 백신(CoronaVac)의 효능 및 안전성: 터키에서 이중 맹검, 무작위, 위약 대조, 3상 시험의 중간 결과

Clinical Trial

Published on 2021-07-172022-09-12
Journal: Lancet (London, England) [Category] Fulltext, SARS, 임상, 진단,

[키워드] 1:1 95% CI adverse event adverse events antibody test result bleeding disorders blood product clinical trial Cohort component CoronaVac COVID-19 criteria dose double-blind Efficacy Efficacy and safety enrolled exclusion fatality fatigue follow-up period Frequency health-care humoral hydroxide Immunoglobulin immunosuppressive inactivated individual intention-to-treat intention-to-treat population intramuscularly IQR Local median Negative PCR nine Older outcome Pain participant PCR-confirmed per 1000 person-years per protocol Phase 3 phase 3 trial Placebo placebo-controlled protocol provided randomised Randomly recruited Registered reported safety analysis safety profile SARS-CoV-2 screened second dose shown Steroids symptomatic the placebo group the vaccine therapy Tolerability trials Turkey Vaccine virion virus Volunteer whole-virion SARS-CoV-2 vaccine yielding
[DOI] 10.1016/S0140-6736(21)01429-X PMC 바로가기 [Article Type] Clinical Trial

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 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

Clofazimine for Treatment of Cryptosporidiosis in Human Immunodeficiency Virus Infected Adults: An Experimental Medicine, Randomized, Double-blind, Placebo-controlled Phase 2a Trial

인간 면역 결핍 바이러스 감염된 성인에서 cryptosporidiosis의 치료를위한 clofazimine : 실험 의학, 무작위, 이중 맹검, 위약 대조 2A 시험

Major Articles and Commentaries

Published on 2021-07-152022-09-06
Journal: Clinical Infectious Diseases: An Official Publicat [Category] Communicable Disease,

[키워드] abdominal pain according to protocol adverse effect Analysis antiretroviral ARV ARV therapy ATP blueprint CD4 counts CFZ clinical Clofazimine controls cryptosporidiosis cryptosporidium diarrhea diarrheal did not reduce died double-blind drug Efficacy evaluated failure form HIV HIV population Human Human immunodeficiency virus identify Immunocompromised immunodeficiency virus individual Infection limit malaise Medicine outcome over Part participant pathway Patient performed pharmacokinetics phase Placebo placebo group placebo-controlled study Plasma level Plasma levels primary analysis Primary outcomes Randomized randomized, double-blind, placebo-controlled study reduction in Registration Result Screening Stool Support the placebo group therapeutic therapeutic potential therapy treated Treatment Trial trials Viral Viral load with HIV
[DOI] 10.1093/cid/ciaa421 PMC 바로가기 [Article Type] Major Articles and Commentaries

Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial

Research

Published on 2021-07-082022-10-05
Journal: Nature Medicine [Category] 바이오마커, 임상,