enrolment – Page 14 – Communicable Diseases Research

Safety and efficacy of herbal extracts to restore respiratory health and improve innate immunity in COVID-19 positive patients with mild to moderate severity: A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-11-232022-10-29
Journal: Trials [Category] COVID-19, SARS,

Safety and feasibility of umbilical cord mesenchymal stem cells in patients with COVID‐19 pneumonia: A pilot study

Original Article

Published on 2020-11-172022-10-31
Journal: Cell Proliferation [Category] COVID-19, SARS,

[키워드] addition adverse event Allergic reactions CD4 CD8 Clinical efficacy conducted CORD coronavirus coronavirus disease‐2019 COVID‐19 COVID‐19 patients cytokine Cytokine storm Day enrolled enrolment evaluated feasibility feasible Ground glass opacity inflammatory biomarkers investigated Lymphocyte count Lymphocyte subset Mortality mortality rate NK cells objective oxygenation index Patient performed pilot study Pneumonia radiological recorded Result Safe Safety Standard therapy STEM stem cell subset T cell T cells the disease Treatment Trial umbilical umbilical cord mesenchymal stem cells
[DOI] 10.1111/cpr.12947 PMC 바로가기 [Article Type] Original Article

Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-10-302022-10-29
Journal: Trials [Category] Coronavirus, MERS, SARS,

[키워드] adjuvant Administered Adverse age alanine aminotransferase All study participant allergy approved ARDS Aspartate transaminase Aspirin atorvastatin benefit bleeding block randomization Breastfeeding C-reactive protein characterized clinical Clinical deterioration Clinical improvement Clinical outcome Coagulopathy collected data computer-generated conducted confirmed case control group COVID-19 COVID-19 patient COVID-19 patients CPK creatine phosphokinase Critical derivative discharge dissemination dose drug drug interaction ECMO Effect element Endotracheal intubation enrolment ethical committee evaluated examined excluded exclusion criteria Final Hepatitis HIV Hospital admission hospital discharge hospitalisation ICMR ICU admission in-hospital mortality include Inclusion India infected with SARS-CoV-2 Inflammatory marker interim analysis liver management mechanical ventilation Medical Science medication Mortality myalgia National Cancer Institute New Non-invasive number objective Open-label Other outbreak outcome outcomes pandemic parallel-group participant Patient patients Platelet Pregnancy Primary outcome progression Protease inhibitor protease inhibitors protocol randomised Randomised control trial randomised controlled trial randomize Randomized receiving recruited recruitment reference Registered registry renal replacement therapy respiratory RT-PCR Sample size SARS-CoV-2 SARS-COV-2 infection secondary outcome serum Shock statin status study period Study protocol supplementary material symptom onset Tablet therapy Treatment protocol Trial troponin usual care website WHO written consent written Informed Consent
[DOI] 10.1186/s13063-020-04840-y PMC 바로가기 [Article Type] Letter

Autoantibodies against type I IFNs in patients with life-threatening COVID-19

생명을 위협하는 COVID-19 환자에서 I형 IFN에 대한 자가항체

Research Article

Published on 2020-10-232022-08-13
Journal: Science (New York, N.y.) [Category] MERS, SARS, 유전자 메커니즘,

[키워드] Activation acute disease acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adaptive Affect affected age antiviral immunity Asymptomatic auto-Ab auto-Abs autoantibodies autoantibody autoantibody system Autoimmune Autoimmunity B cell Beck binding can not candidate gene approach cause causes Clinical course clinical phenotype clinical phenotypes clinical variability collected complex component components Concentration conditions coronavirus coronavirus disease Coronavirus disease 2019 correlated Course COVID-19 COVID-19 pandemic COVID-19 patients COVID-19 pneumonia Critical Critical disease cytokine Cytokines damage dampen death determine disease Diseases downstream enrichment enrolment epidemiological excess explain Genes genetics genomics study had milder phenotype healthy control healthy individual healthy individuals highest Human Hypothesis identify IFN IFN response IFN-stimulated genes IFN-α IFN-α/β IFN-α2 IFN-β IFN-γ IFNAR IFNs IgG IL-17A IL-6 immune system Immunity Immunoglobulin Immunoglobulin G immunological impair impairing in healthy individuals in vitro Inborn errors increase in individual infected with SARS-CoV-2 Infection Infectious diseases interferon interferon regulatory factor interferon-γ interferons interferons (IFNs) interleukin interleukin-6 intrinsic involved IRF ISGs lack life-threatening life-threatening coronavirus disease likelihood male mechanism men mild SARS-CoV-2 infection morbidity morbidity and mortality mucocutaneous candidiasis Mutation mycobacterial disease neutralize Neutralizing outcomes pandemic pathogen pathogen-induced inflammation pathway Patient patients patients hospitalized Perspective phosphorylated Plasmapheresis Pneumonia Prevent pSTAT receptor receptors Regulation respiratory rising risk risk factor SARS-CoV-2 SARS-COV-2 infection Science searched serum IFN-α level severe acute respiratory syndrome Coronavirus severe coronavirus disease severe COVID-19 Severe COVID-19 pneumonia shown silent infection staphylococcal susceptible tested the patient this system TLR Toll-like receptor Transcription Treatment trials type 1 interferon type 1 interferons type I Type I IFN type I IFNs underlie undetectable Vaccine Viral viral infections viral respiratory diseases while women
[DOI] 10.1126/science.abd4585 PMC 바로가기 [Article Type] Research Article

Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection – a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial

Letter

Published on 2020-10-202022-10-29
Journal: Trials [Category] COVID-19, MERS, SARS,

[키워드] 1:1 2019-nCoV allergic Antipyretic Antiretroviral therapy Antiviral Arm as required assigned Breastfeeding Care categories cause clinical combination therapy compassionate use cough country COVID-19 COVID-19 infection criteria death defined described discharged disease dissemination drug Efficacy element eligibility criteria enrolled enrolment Etiquette exclusion criteria exploratory female Fever Frequency H1N1 hand hygiene Hydration Hydroxychloroquine ICU Patients inclusion criteria India Infection infection with SARS-CoV-2 investigator Laboratory Loading dose Lopinavir/ritonavir Lopinavir/Ritonavir combination mechanical ventilation medication Mortality non-ICU non-invasive ventilation Non-severe case Normalisation number nutrition objective off-label organ oxygen saturation paO2/fiO2 participant Participants Patient pharmacotherapy Placebo positive Precaution progression protocol QT prolongation randomisation randomised randomised controlled trial randomization Randomized controlled trial Randomly receipt recruitment regimen Registration registry replaced required Research respiratory rate ribavirin RT-PCR Safety Sample size SARS-CoV-2 RT-PCR screened secondary secure Serious Adverse Event Severe COVID-19 Infection Severe patient severity specimen Standard standard treatment status stratified study period Study protocol supplemental oxygen Support Suppressant surgical sustained symptomatic patient Tablet tested the patient therapeutic intervention therapy time time to defervescence treated Treatment treatment arm treatment group Trial upper respiratory tract Vasopressor Ventilation ventilator wear website
[DOI] 10.1186/s13063-020-04774-5 PMC 바로가기 [Article Type] Letter

An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-10-132022-10-29
Journal: Trials [Category] COVID-19, MERS, SARS,

[키워드] 1:1 7-point ordinal scale adaptive Alfred Hospital allergy Antiviral Antiviral treatment Arm biomarkers of inflammation blinded to treatment childbearing potential clinical clinical benefit clinical symptom clinical trial Community Confirmed Contraception COVID-19 COVID-19 infection Day defined determine dialysis dissemination dose effective Efficacy element eligible enrolled enrolment Favipiravir female fertile GRADE hospitalisation hospitalised immune activation ineligible investigator male medication negative pregnancy test nucleic acid number objective outcome parallel-group participant Participants Patient performed Pharmacy Placebo protocol randomisation randomised randomised controlled trial recruit recruited recruitment renal impairment Sample size SARS-CoV-2 Screening secondary severe hepatic dysfunction Standard of care status stratified Study protocol study visit Swab Symptom the WHO time Treatment Trial triple-blind Victoria virological cure website
[DOI] 10.1186/s13063-020-04766-5 PMC 바로가기 [Article Type] Letter

Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial)

증상이 있는 SARS-CoV-2 감염(COVID-19)이 있는 고령자의 가정 치료: 여러 가지 실험적 치료의 효능과 내약성을 평가하기 위한 MAMS(Multi-Arm Multi-Stage) 무작위 시험에 대한 연구 프로토콜의 구조화된 요약 65세 이상 외래 환자의 입원 또는 사망 위험 감소(COVERAGE 시험)

Letter

Published on 2020-10-132022-08-13
Journal: Trials [Category] MERS, SARS, 임상,

[키워드] 6-mercaptopurine Abnormalities ACEi added age amodiaquine Analysis antrafenine approved ARB ARBs Arm azathioprine Blinding Bordeaux Caregivers Chloroquine chronic hepatitis Chronic kidney disease citalopram clinical Colitis Combination comparator complex conducted Control control arm COVID-19 COVID-19 pandemic criteria CYP3A4 cytochrome P450 Dasatinib death Dementia dialysis dissemination Domperidone drug Duchy Efficacy element enrolled enrolment Enterocolitis escitalopram EudraCT Evidence exclusion criteria experimental arm experimental drug Experimental drugs Favipiravir feasibility Final final analysis first symptom first symptoms floctafenine France French futility galactose GFR glafenine Glucose Glucose-6-phosphate glucose-6-phosphate dehydrogenase glucose-6-phosphate dehydrogenase deficiency Grand duchy halofantrine Health Insurance heart rate hepatic Hepatic porphyria home hospital hospitalisation Hydroxychloroquine hydroxyzine hypersensitivity Hyperuricemia Ileus Imatinib immunological incidence Inclusion increase in inducer inhibitor Interim analyses interim analysis intervals investigator investigators Isoenzyme Kidney disease Lactase Lactose liver failure Long Long QT syndrome Luxembourg malabsorption mefloquine mercaptopurine metabolism multi multi-arm nasopharyngeal Nasopharyngeal swab New Nilotinib not blinded number nursing home nursing homes objective Older Open-label open-label trial other treatment other treatments outcome Outpatient P450 Paris participant Patient performed phase Piperaquine Positive test Prevent primary care Primary outcome proportion protocol pyrazinamide QTc interval randomisation randomised Randomized Randomly receive recruited Region Registered regulatory authority repaglinide replaced REPLACED BY reported Repurposed drug residence Safety Monitoring Board Sample size SARS-CoV-2 SARS-COV-2 infection scale Stage Standard statistician statisticians status stratified Study protocol submitted symptomatic SARS-CoV-2 infection Tablet telmisartan tested theophylline Toxicity Trace element trace elements treated Treatment treatment arm Trial Trial registration Version virus Virus Disease Vitamin vitamins Warfarin
[DOI] 10.1186/s13063-020-04619-1 PMC 바로가기 [Article Type] Letter

Redefining the Prognostic Value of High-Sensitivity Troponin in COVID-19 Patients: The Importance of Concomitant Coronary Artery Disease

Article

Published on 2020-10-122022-10-30
Journal: Journal of Clinical Medicine [Category] COVID-19,

How achievable are COVID-19 clinical trial recruitment targets? A UK observational cohort study and trials registry analysis

Infectious Diseases

Published on 2020-10-052022-10-28
Journal: BMJ Open [Category] COVID-19, Fulltext, MERS, SARS,

[키워드] Admitted Patient analysed Analysis biostatistics clinical trial clinical trials Complete Controlled COVID-19 COVID-19 pandemic database declined determine discharge eligibility England enrolled enrolment exclusion feasible First wave FIVE hospitalisation hospitalised hospitalised patient Infection Infectious diseases laboratory-confirmed SARS-CoV-2 infection limit Medical Research Council number objective Observational cohort study ongoing trials outcome measure Palliative care Pandemics participant patient cohort Population proliferation prospective observational study randomisation receiving recovery recruitment Registered required Result setting Standard Study design target Treatment Trial Trial registration trials UK Government unit were excluded with COVID-19
[DOI] 10.1136/bmjopen-2020-044566 PMC 바로가기 [Article Type] Infectious Diseases

Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-09-092022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 24 hour 7-point ordinal scale absence addition administration Admission ALT anticipated assigned AST baseline biological parameters candidate Care clinical Clinical research clinical status clinical trial clinician Comorbidity conditions Control control arm control group Coronavirus infections Council COVID 19 COVID-19 COVID-19 infection criteria current D-dimer Day death rate decrease discharge dissemination dose drug Duration early stage Efficacy element ELISA enrolment EudraCT European evaluate exclusion criteria exploratory extracorporeal membrane oxygenation Frame harmonization hospitalisation hospitalised hospitalised patient hyperinflammatory status hypersensitivity Hypothesis identify IL-6 IL-6 levels IL-6 receptor inhibitors IL-6R In-hospital incidence Inclusion inclusion criteria independent Infection Informed inhibitor interstitial pneumonia Intervention intervention group intestinal perforation Invasive mechanical ventilation investigator investigator-initiated lactation Local marker measure mechanical ventilation moderate moderate-severe neutrophil count Non-invasive non-invasive ventilation number number of death objective Open label trial outbreak outcome oxygen Oxygenation pandemic participant pathogen patients treated performed Platelet Pneumonia positive positive RT-PCR Positive test Prednisone Presence Prevent progression protocol random randomisation randomised randomised controlled trial receive recruited recruitment Registered reported requiring supplemental oxygen responsible routine clinical practice RT-PCR SAEs Sample size sarilumab SARS-CoV-2 SARS-COV-2 infection score Sepsis Serious Adverse Event serum Severe COVID-19 Infection single center single dose Spain Standard Standard of care status Study protocol Subcutaneous subcutaneous injection the patient therapy treated Treatment treatment arm treatment with tocilizumab Trial ULN union unit verbal website
[DOI] 10.1186/s13063-020-04588-5 PMC 바로가기 [Article Type] Letter