A phase I/II dose-escalation multi-center study to evaluate the safety of infusion of natural killer cells or memory T cells as adoptive therapy in coronavirus pneumonia and/or lymphopenia: RELEASE study protocol코로나바이러스 폐렴 및/또는 림프구감소증에서 자연살해세포 또는 기억 T 세포 주입의 안전성을 평가하기 위한 1/2상 용량 증량 다기관 연구: RELEASE 연구 프로토콜Study Protocol Published on 2021-10-022022-09-10 Journal: Trials [Category] MERS, SARS, 임상, [키워드] 1:1 administration Allogeneic alloreactivity ARMS assigned Biology can be used Cell clinical trial convalescent Coronavirus pneumonia COVID-19 COVID-19 patient determine Donor dose dose-escalation dysregulated Efficacy evaluate facilitate HLA immune system Immunotherapy lymphopenia mechanical ventilation memory memory T memory T cell memory T cells nasal nasal cannula natural killer natural killer cell NK cell NK cells Open-label oxygen Oxygen requirement oxygen supplementation Patient patients Phase 2 Phase I Pneumonia protocol Randomized receive Safety SOC Standard of care Study protocol supplementary material T cell T cell lymphopenia T cells T-lymphocyte the patient therapeutic window therapy Tolerability treat Treatment Trial Trial registration Viral [DOI] 10.1186/s13063-021-05625-7 PMC 바로가기 [Article Type] Study Protocol
Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial청소년 및 노인의 SARS-COV-2 재조합 스파이크 단백질 백신 (NVX-COV2373)의 상이한 용량 요법 : 2 상 무작위 위약 대조 시험Clinical Trial Published on 2021-10-012022-08-13 Journal: PLoS Medicine [Category] Biochemistry, MERS, SARS, 임상, 진단, [키워드] 95% CI 95% confidence interval accumulate addition Administered Adults adverse events age Anti-spike Antibody Response assessments assigned composed conducted convalescent sera coronavirus Day dose dose regimen Efficacy Endpoint Enrollment exceeded Follow-up Formica Frequency full-length SARS-CoV-2 geometric mean geometric mean titer geometric mean titers GMTs group groups identify IgG immune persistence immune response immune responses immunogenic immunogenicity Immunoglobulin Immunoglobulin G include inhibitory concentration intensity intramuscular dose lack limitation Matrix-M1 adjuvant median Mild mild to moderate moderate neutralizing antibody Neutralizing antibody response neutralizing antibody responses NVX-CoV2373 occurred less Older Older adults participant Participants Phase 1 Phase 2 Placebo placebo-controlled placebo-controlled trial primary endpoints Protein Randomized randomized placebo-controlled trial Randomly reactogenicity receive Recombinant spike protein regimen researcher respiratory Respiratory Coronavirus robust safety follow-up SARS-CoV-2 second dose second vaccination secondary endpoint seroconversion rate seroconversion rates severity short duration spike glycoprotein spike glycoproteins Spike protein Support The United States These data Tolerability Treatment Trial Trial registration trimeric United States USA vaccination Vaccine vaccine group wild-type virus [DOI] 10.1371/journal.pmed.1003769 PMC 바로가기 [Article Type] Clinical Trial
The COVID-19 Outpatient Pragmatic Platform Study (COPPS): Study design of a multi-center pragmatic platform trialRandomized Controlled Trial Published on 2021-09-012022-10-05 Journal: Contemporary clinical trials [Category] SARS, 임상, [키워드] adaptive approach blinded clinical clinical trial collected competing controls COVID-19 COVID-19 treatment domain effective enrolled evaluate flexible improve clinical outcome inactive Inconclusive likelihood Master nasal swabs Outpatient overcome participant Patient patients phase Phase 2 platform Platform trial potential participant Pragmatic Probability public health Randomized receive recruit reduce Registered required risk SARS-CoV-2 Stanford University Statistical power therapeutic treating COVID-19 Treatment Trial trials viral shedding [DOI] 10.1016/j.cct.2021.106509 PMC 바로가기 [Article Type] Randomized Controlled Trial
Validation and implementation of a direct RT-qPCR method for rapid screening of SARS-CoV-2 infection by using non-invasive saliva samples비침습적 타액 샘플을 사용하여 SARS-CoV-2 감염의 신속한 스크리닝을 위한 직접 RT-qPCR 방법의 검증 및 구현Article Published on 2021-09-012022-09-11 Journal: International Journal of Infectious Diseases [Category] SARS, 치료기술, [키워드] 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Asymptomatic Barcelona comparable conducted coronavirus COVID-19 diagnostic diagnostic sensitivity Direct health worker hospital implementation less nasopharyngeal specimen Non-invasive participant PCR Phase 1 Phase 2 Phase 3 pilot screening positive positive result processed RNA RNA extraction RT-qPCR Saliva saliva samples SARS-CoV-2 SARS-COV-2 infection scaled up Screening screening method Sensitivity and specificity severe acute respiratory syndrome Coronavirus Spain supervision Surveillance validation virus inactivation [DOI] 10.1016/j.ijid.2021.07.054 PMC 바로가기 [Article Type] Article
Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2SARS-COV-2에 대한 강력한 항 바이러스 활성을 갖는 리보 뉴 클레오 사이드 유사체 인 EIDD-2801/MK-4482 (Molnupiravir)의 최초 인간 임상 시험의 가속화 된 인간 임상 시험.Randomized Controlled Trial Published on 2021-08-232022-08-13 Journal: Trials [Category] MERS, 임상, 치료제, [키워드] accelerated Accelerated start-up acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 administration Antiviral antiviral activity antiviral agent approval causative agent Clinical data clinical trial Cohort cohorts collaboration Complete completion contract research organization coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 CRO daily dose described dose Dose escalation Dosing double-blind drug eight Escalation ethics committee fasted or fed state FDA FIH FIH study followed by food food-effect global pandemic healthy volunteer healthy volunteers initial initiated MAD MAD cohort MAD cohorts Medicine Medicines Medicines and Healthcare products Regulatory Agency MHRA molnupiravir multiple ascending dose Painter pharmacokinetic Phase 2 phase 2 dosing Phase 2 study phase 2/3 Phase I Placebo profile protocol Randomized REC receive receiving Regulatory Regulatory Authorities regulatory authority Research Ethics Research Ethics Committee respiratory Ribonucleoside analog SAD cohort Safe SARS-CoV-2 sequence Seven severe acute respiratory syndrome Coronavirus single ascending dose Sponsor subject submission supported timelines Tolerability United Kingdom US Food and Drug Administration were dosed working [DOI] 10.1186/s13063-021-05538-5 PMC 바로가기 [Article Type] Randomized Controlled Trial
Randomized, placebo controlled, double blinded pilot superiority phase 2 trial to evaluate the effect of curcumin in moderate to severe asthmatics중등도 내지 중증 천식에서 커큐민의 효과를 평가하기위한 무작위, 위약 제어, 이중 블라인드 파일럿 우월성 2 단계 시험Study Protocol Published on 2021-08-172022-09-01 Journal: BMC Pulmonary Medicine [Category] Fulltext, MERS, SARS, 비임상, 임상, 진단, [키워드] adjunct adopted anorexia Anti-inflammatory anti-inflammatory properties Anti-oxidant approved Arthritis Asthma baseline benefit blinded Blood breath by mouth can be used change clinic visit Clinic visits contribute control test COVID-19 COVID-19 pandemic Curcumin derivative determine Enzymes eosinophil Eosinophil count evaluate the effect finding Follow-up FVC IgE Inflammatory Inflammatory marker inflammatory markers institutional review board Intervention Lung diseases Lung inflammation matching placebo medical condition mice moderate Moderate asthma moderate to severe mouth pathway Patient patients with moderate Phase 2 phase 2 trial Placebo predicted Randomized receiving reducing reduction in screening visit Severe asthma shown Study design study period Study protocol therapeutic effect therapeutic effects therapy treat Treatment Trial registration university USA [DOI] 10.1186/s12890-021-01619-y PMC 바로가기 [Article Type] Study Protocol
Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 TrialArticle Published on 2021-08-122022-10-30 Journal: Journal of Clinical Medicine [Category] COVID-19, [키워드] 95% confidence interval acute respiratory syndrome adverse event Analysis antiviral agent Antiviral agents assigned Ciclesonide clinical clinical trial conducted coronavirus coronavirus disease COVID-19 Diagnosis drug effective Efficacy enrolled evaluate evaluated groups High-flow nasal oxygen inhalation inhaler inhibit intravenous mechanical ventilation Mild-to-moderate multicenter nasopharyngeal viral load Negative conversion Open-label Patient per day Phase 2 polymerase chain primary endpoint progression Quantitative Randomized Randomly receive Registration Respiratory failure reverse transcription SARS-CoV-2 SARS-CoV-2 viral shedding significantly higher significantly lower standard care study enrollment symptom onset therapy treat Treatment [DOI] 10.3390/jcm10163545 PMC 바로가기 [Article Type] Article
Impact of the COVID-19 pandemic on phase 2 cardiac rehabilitation patients in JapanObservational Study Published on 2021-08-012022-10-05 Journal: Heart and vessels [Category] SARS, 임상, [키워드] aerobic affected age Analysis body mass index Borg city COVID-19 COVID-19 pandemic criterion Dyspnea Effect enrolled fatigue Final frailty hemodynamic Hemodynamic response Impact Inclusion increased risk intensity Japan Outpatient outpatients Patient Phase 2 Phase 2 cardiac rehabilitation patient Rating of perceived exertion. rehabilitation rehabilitation patient RPE significantly was performed worsened [DOI] 10.1007/s00380-021-01783-5 PMC 바로가기 [Article Type] Observational Study
Nationwide Seroprevalence of SARS-CoV-2 IgG Antibodies among Four Groups of Primary Health-Care Workers and Their Household Contacts 6 Months after the Initiation of the COVID-19 Vaccination Campaign in France: SeroPRIM Study ProtocolStudy Protocol Published on 2021-07-202022-10-28 Journal: Pathogens [Category] COVID-19, [키워드] asked Blood COVID-19 dentist detect determine ELISA evaluate Evolution France group health-care household household contact household contacts humoral IgG antibody Immune status information Initiation Month participant Phase 1 Phase 2 Population practitioners primary health-care workers protocol questionnaire repeated risk factor SARS-CoV-2 SARS-CoV-2 IgG serological Seroprevalence specific IgG antibody Symptoms vaccination virus neutralization test worker [DOI] 10.3390/pathogens10070911 PMC 바로가기 [Article Type] Study Protocol
Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials18 세 이상의 건강한 인구에서 재조합 코비드 -19 백신 (SF9 세포)의 안전성 및 면역 원성 : 2 개의 단일 센터, 무작위, 이중 맹검, 위약 대조, 1 상 및 2 상 시험의 안전성 및 면역 원성Clinical Trial Published on 2021-07-152022-08-13 Journal: Signal Transduction and Targeted Therapy [Category] Fulltext, SARS, 임상, [키워드] (phase 1 (phase 2 (phase 2) 95% CI Adverse reaction Adverse reactions antibody assigned candidate vaccine China cough COVID-19 vaccine COVID-19 vaccines dose double-blind Eligible participants ELISA enrolled fatigue Fever GMT GMTs headache healthy High dose high dose vaccine highest immune response immune responses immunogenicity injection live SARS-CoV-2 low dose vaccine Neutralising Antibodies neutralising antibody Older Pain participant peaked Phase 1 phase 1 trial Phase 2 phase 2 trial Placebo placebo-controlled problem randomised Randomly receive recombinant COVID-19 vaccine Safe Safety schedule Sf9 cells single-center sore throat Specific Specific T-cell response T-cell Response Tolerability Trial trials vaccination Vaccine Vaccines [DOI] 10.1038/s41392-021-00692-3 PMC 바로가기 [Article Type] Clinical Trial