Informed consent – Page 6 – Communicable Diseases Research

COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union

COVID-19 및 유럽 연합에서 진행 중인 임상 시험에 대한 새로운 규제 지침

Article

Published on 2021-06-012022-09-11
Journal: Clinical Pharmacology and Therapeutics [Category] MERS, SARS, 신약개발, 임상,

Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial

입원 중인 COVID-19 환자의 회복기 혈장 사용의 안전성과 효능을 평가하기 위한 무작위 임상 시험(PERUCONPLASMA): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-05-172022-09-01
Journal: Trials [Category] SARS, 임상, 진단, 치료기술,

[키워드] 1:1 ABO blood type Acute coronary syndrome administration Adverse reaction Adverse reactions aliquot Aliquots All participants allocation anaphylaxis antibody Antigen assessment Bilirubin Blinding block blocks blood gas blood gas analysis blood type C-reactive protein calculated Capacity carried case report form clinical clinical trial clinical trials Coagulation Coma completion confidence level congestive heart failure contraindication control group convalescent plasma coronary syndrome COVID-19 COVID-19 disease COVID-19 pneumonia creatinine Critical Critical disease CRP current D-dimer decrease defined detect Diagnosis dialysis disease Disseminated intravascular coagulation dissemination Donor donors drop Duration Dynamics eCRF Efficacy electronic case report form element eligible enrolled enrolment etiology evaluate evaluated events Evolution exclusion criteria expected experimental group exploratory failure following gas analysis hemodynamic instability hemorrhage hospital hospital discharge Hospitalization Hospitalized hospitalized patient hospitalized patients Hypothesis Hypoxemia ICU IIb in-hospital mortality Inclusion Infarction Inflammatory information Informed consent intensive care intensive care unit Intervention intracranial hemorrhage intravascular coagulation Invasive mechanical ventilation investigator investigators jaundice Laboratory laboratory confirmation Laboratory test Lactate lactate dehydrogenase Length less Local lymphocyte male marker Mechanical mechanical ventilation mmHg molecular Mortality multi-organ failure Myocardial infarction Neutralizing antibodies number objective occur Older open open label outcome oxygen Oxygen requirement oxygen saturation PaO participant Patient performed plasma Platelets Pneumonia power power of 80% previous diagnosis Probability protocol Public Hospital public hospitals quantification randomization Randomized Randomized controlled trial rationale receive reduce reducing reduction Registered resolution of symptom respiratory respiratory rate routine clinical practice Safe Safety Sample size SARS-COV-2 infection score Secondary objectives serious adverse reaction Serious adverse reactions serologic serum serum creatinine severe COVID-19 Severe COVID-19 pneumonia severe disease SOFA specific type standard treatment standard treatment alone statistical analysis Study protocol Stupor subject supplementary material Total total bilirubin transfusion treatment arm Trial uncontrolled vasopressors Ventilation website with COVID-19
[DOI] 10.1186/s13063-021-05189-6 PMC 바로가기 [Article Type] Letter

Reconvalescent plasma/camostat mesylate in early SARS-CoV-2 Q-PCR positive high-risk individuals (RES-Q-HR): a structured summary of a study protocol for a randomized controlled trial

초기 SARS-CoV-2 Q-PCR 양성 고위험 개인(RES-Q-HR)의 회복기 혈장/카모스타트 메실레이트: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-05-172022-08-31
Journal: Trials [Category] SARS, 임상, 치료기술, 치료제,

[키워드] accommodation acts Administered administration Adult patients Adverse adverse events alcohol Alcohol Abuse ALT anti-SARS-CoV-2 antibodies anti-SARS-CoV-2 antibody anticancer Antiviral antiviral therapy appearance approved AST blinded Blinding BMI body weight Bone marrow Breastfeeding CAD camostat Camostat mesylate Capsule Care Caregivers Cell Child chronic Chronic kidney disease chronic obstructive pulmonary disease chronic obstructive pulmonary disease (COPD) cirrhosis CKD clinical clinical condition Compliance Concomitant concurrent conducted control group Controlled trial convalescent plasma COPD Coronary artery Coronary artery disease cough COVID-19 COVID-19 pneumonia criteria cumulative defined diabetes Diabetes Mellitus diagnosed diagnosis of SARS-CoV-2 diarrhea disease Disease progression disease stage disorder dissemination double-blind Duration early disease Early phase of SARS-CoV-2 infection Efficacy element enrolled Enrollment enrolment EudraCT evaluate evening event evidence of Exanthema excluded exclusion criteria fatigue Fever fibrosis Germany GFR half-live headache high risk higher risk Hospitalization Hospitalized host cell hypersensitivity IgA deficiency immunization Inclusion inclusion criteria increased risk independent individual Infection infection with SARS-CoV-2 Influenza influenza A Informed consent inhibitor institution intervention arm intervention arms Kidney disease less Life expectancy likelihood Liver cirrhosis Local local Ethics Committee Mask mesylate moderate mother multicenter nasal nasal cannula Neutralizing number objective Obstructive obstructive pulmonary disease Older Ordinal Scale organ outcome outcomes oxygen oxygen demand Pancreatitis parallel group participant Participants passive immunization Patient patients hospitalized PCR Placebo plasma Plasma transfusion Pneumonia positive pregnant women Presence Prevent prevent disease progression primary endpoint progression protocol pulmonary disease pulmonary fibrosis Q-PCR randomization Randomized Randomized controlled trial receive recruitment reduce Regulatory reported risk factor safety monitoring committee Sample size SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 PCR screening visit Serine serine protease TMPRSS2 Serious Adverse Event Serious Adverse Events severe COVID-19 Shortness of breath SOC sore throat Stage Standard Standard of care stratified Stress Study protocol supplementary material Symptom symptom duration Symptoms tertiary care center tested the cell titers TMPRSS2 transfusion reaction Treatment treatment arm Trial Trial registration Tumor typical symptom typical symptoms ULN virus website WHO with COVID-19 women working hypothesis written Informed Consent
[DOI] 10.1186/s13063-021-05181-0 PMC 바로가기 [Article Type] Letter

Exploring Risks of Human Challenge Trials For COVID‐19

Article

Published on 2021-05-042023-07-01
Journal: Risk Analysis [Category] SARS,

[키워드] Bayesian meta‐analysis COVID‐19 human challenge trial Informed consent interactive models Risk communication
[DOI] 10.1111/risa.13726 PMC 바로가기

Efficacy and safety of nelfinavir in asymptomatic and mild COVID-19 patients: a structured summary of a study protocol for a multicenter, randomized controlled trial

무증상 및 경증 COVID-19 환자에 대한 nelfinavir의 효능 및 안전성: 다기관, 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-282022-09-10
Journal: Trials [Category] SARS, 임상, 치료기술,

[키워드] 1:1 Administered administration adverse event adverse events age all-cause mortality ALT Analysis anticipated Antigen antiviral efficacy AST Asymptomatic asymptomatic patients blinded blinded outcome assessment Blinding blood glucose body temperature both group both groups capture caused childbearing potential clearance clinical Clinical efficacy clinical examinations Clinical symptoms clinical trial clinical trials comparator Patients condition Consent contraceptive method Controlled clinical trial cough COVID-19 creatinine creatinine clearance dataset Day defervescence diabete diabetes diarrhea discretion dissemination distribution drug element enrolled enrolment evaluate event exclusion criteria exploratory Factor female patient Fever Frequency Glucose group hazard ratio Hemophiliac Hemorrhagic history HIV infection hospital hypersensitivity incidence incidence rate Inclusion inclusion and exclusion criteria inclusion criteria Infection Informed consent initial investigator investigator-initiated investigators Japan Japanese LAMP limit log-rank test male Mild mild COVID-19 patient Mild disease mixed-effects model multicenter Nasopharyngeal swab Negative conversion Negative PCR nelfinavir null hypothesis number objective Open-label outcome oxygen Oxygen administration p value parallel group parameter participant Patient patients with asymptomatic PCR PCR test Pneumonia power Pregnancy primary endpoint Primary outcome principal investigator Probability probability distribution protocol random randomization Randomized Randomized controlled trial Registered registry reported required respiratory tract rifampicin room air safety endpoint Saliva saliva samples Sample size SARS-CoV-2 SARS-CoV-2 vaccination secondary efficacy endpoint serious complication serum creatinine severity specimen Standard status study period Study protocol supplementary material survival survival function Symptom symptomatic symptomatic COVID-19 Symptomatic treatment the log-rank test Three times daily Treatment treatment for HIV treatment period Trial Trial registration two-sided Unsuitable Viral viral dynamics Viral load virus was determined website Withdrawal withdrawal of consent
[DOI] 10.1186/s13063-021-05282-w PMC 바로가기 [Article Type] Letter

Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials

COVID-19 백신 시험에 대한 사전 동의 문서의 길이 및 가독성 평가

Research

Published on 2021-04-282022-09-10
Journal: JAMA Network Open [Category] MERS, SARS, 임상,

[키워드] Accessibility Analysis analyzed assessment average CLARITY clinical trials collected complex complexity conducted Consent COVID-19 COVID-19 vaccine COVID-19 vaccine trial COVID-19 vaccine trials document effective enrolled examined exceeded explain finding Formal GRADE ideal Importance IMPROVE Informed Informed consent Length Level measure minute not difficult objective outcome participant Participants placebo group Point Quality improvement randomized clinical trial randomized clinical trials Readability reading receive reduce Relevance Research Research Ethics Result Safe score scored secondary Secondary outcomes setting the placebo group the vaccine Trial trials Vaccine
[DOI] 10.1001/jamanetworkopen.2021.10843 PMC 바로가기 [Article Type] Research

Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial

COVID-19 환자를 위한 천연 탄닌 추출물 보충제(TanCOVID): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-282022-09-10
Journal: Trials [Category] MERS, SARS, 임상,

[키워드] 1:1 24 hour 24 hours addition Administered administration affected age All trial participants all-cause mortality Alpha alpha error Antibiotic therapy antipyretics assigned assisted ventilation Azithromycin B12 blinded Blinding branch Buenos Aire Buenos Aires can not Chestnut tannins Clinical symptoms clinical trial closure cognitive computer-generated random numbering conditions Consent control group COVID-19 COVID-19 patient criteria cytokine Cytokines Day Decline decrease defined Definition Department described diagnosis of SARS-CoV-2 dietary supplement difference disease dissemination dose double-blind Efficacy element eligibility eligible enrolled Enrollment enrolment epidemiological evaluate excluded fecal Final first dose first visit Gender gut microbiota Hospital de Clínica Hospital de Clínicas Hospital de Clinicas Jose de San Martin hospital discharge Hydroxychloroquine hypersensitivity ICU impaired consciousness increase in indicated Infection Infectious disease Infectious diseases Inflammation inflammatory mediator Inflammatory mediators Informed consent intestinal intestinal permeability invasive ventilation lactating Level Lopinavir mean difference measure mechanical ventilation mediators microbiota modifications molecular natural non-invasive ventilation number objective Older outcome parallel-group parameter participant Participation Patient patients per day Placebo placebo-controlled platform Potential power power of 80% protocol Quebracho tannins randomization Randomized Randomized controlled trial Randomly Real-time PCR receive recruited recruitment Registered Research Ritonavir Sample size SARS-COV-2 infection SARS-CoV2 screened secondary secondary outcome measures severity Standard therapy standard treatment status study participant Study protocol study randomization submitted supplementary material supply tannin tannins therapy time Time frame took place Treatment treatment allocation Trial trial participant Trial registration undergo university Ventilation website
[DOI] 10.1186/s13063-021-05281-x PMC 바로가기 [Article Type] Letter

Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic

동의를 포함한 모니터링 발전: 대유행 기간 동안 UKCRC에 등록된 임상 시험 단위에서 실행되는 COVID-19 시험 및 기타 시험에서 학습

Research

Published on 2021-04-142022-09-10
Journal: Trials [Category] MERS, 임상,

Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial

경증 또는 중등도의 COVID-19 폐렴으로 입원한 환자를 위한 염증 신호 억제제(MATIS)의 다군 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-122022-09-10
Journal: Trials [Category] 임상,

[키워드] 24 hours accounted Administered age agreement All participants Allergic reactions approved baseline blind blinded Blinding block Breastfeeding Caregivers cell proliferation childbearing potential clinical clinical outcomes clinically suspected college comparator completion Compliance Concomitant medication Contraception Controlled trial coronavirus COVID-19 COVID-19 disease COVID-19 pneumonia CPAP CRP Data monitoring committee Day death defined Desaturation determine diagnosed disease disease severity dissemination dose drug ECMO effective Efficacy element English enrolment exclusion experimental arm experimental intervention facemask FOS fostamatinib generate GRADE grade 3 Graft graft-versus-host-disease hepatic dysfunction hospital Hospital admission Hospital stay hospitalisation hospitalised patient Hospitalised patients Immune thrombocytopenia Imperial College Healthcare NHS Trust incidence information Informed consent inhibitor Inpatient Inpatients Intervention invasive Invasive mechanical ventilation invasive ventilation investigational agent investigator JAK1 JAK2 janus kinase Kinase inhibitor kinases Laboratory male participants MATIS Mild minimum moderate Moderate COVID-19 moderate to severe Modification multi-arm myelofibrosis nasal oxygen NHS Non-invasive non-invasive ventilation number objective Obstructive obstructive sleep apnoea opinion Ordinal Scale outcome oxygen Pairwise comparison pandemic parallel-group participant Patient Pneumonia polycythaemia vera principal investigator product progression promise proportion protocol random randomisation randomised randomised controlled trial receiving recruit recruited reduce reduce mortality reducing renal impairment renal replacement therapy replacement therapy required Requirement ruxolitinib Sample size sample size calculation Sample size calculations SARS-CoV2 infection scale Secondary objectives selective sequence severe allergic reaction Severe COVID-19 pneumonia severity severity of COVID-19 sexual intercourse signal sleep apnoea Sperm sperm donation spleen Splenomegaly Stage stage 2 Standard Standard of care statistical analysis status Stratification study drug Study protocol supplementary material Symptom systemic inflammation the WHO therapy thrombocytopenia translation Treatment Trial Trial registration Trust tyrosine tyrosine kinase inhibitor Venous Thromboembolism verbal website WHO with COVID-19
[DOI] 10.1186/s13063-021-05190-z PMC 바로가기 [Article Type] Letter

Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial

페루의 초기 COVID-19 환자(SAINT-Peru)에서 비인두 PCR을 무효화하기 위해 이버멕틴 대 위약의 효능을 비교하기 위한 무작위 임상 시험(SAINT-Peru): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-04-092022-09-01
Journal: Trials [Category] MERS, 임상, 진단,

[키워드] 1:1 Administered adverse event allergy Amiodarone Anosmia Antiviral attending physician baseline blinded Blinding block childbearing age clarithromycin clinical clinical and laboratory parameters clinical care clinical trial Cobicistat coin conducted control group correlation cough COVID-19 COVID-19 disease COVID-19 patient COVID-19 pneumonia COVID-19 progression criteria Critical current cyclosporine CYP3A4 daily dose death determine determined by diagnosed diagnostic test Diltiazem dissemination dose drug early treatment Efficacy element Eligible patients emergency services enrolled epidemiologist erythromycin evaluate expected Fever follow-up visits generate hospital Hospitalization IgA IgG IgM IIa immune response immunomodulatory in vivo include inclusion criteria Indinavir Infection Informed consent inhibitor Intervention intestinal investigator investigators involved itraconazole Ivermectin ketoconazole laboratory parameter less list lung magnitude medical staff nasopharyngeal nasopharyngeal specimen Nasopharyngeal swab nasopharyngeal swab PCR nasopharyngeal swabs National negative number objective Older outcome oxygen oxygen saturation Parallel Arm participant Patient patients patients with SARS-CoV-2 PCR PCR cycle Peru Pharmacist phase Placebo placebo group placebo-controlled trial Pneumonia positive positive PCR test positive SARS-CoV-2 PCR pregnancy test pregnant women principal investigator progression proportion protocol quinidine randomization list Randomized Randomized controlled trial Randomly Rapid diagnostic test receive recruited reduce Registered Registration Result risk factor Risk factors Ritonavir Sample size SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 PCR SARS-CoV-2 RNA SARS-CoV-2 viral load secondary Secondary objectives Seroconversion Seven severe disease severity spironolactone statistician status study population Study protocol supplementary material Symptom symptomatic Symptomatology Symptoms tacrolimus the patient the placebo group the SARS-CoV-2 threshold Treatment treatment group treatment groups treatment initiation Trial Trial registration two group two groups verapamil Viral Viral load virus Warfarin website with COVID-19 women
[DOI] 10.1186/s13063-021-05236-2 PMC 바로가기 [Article Type] Letter