protocol – Page 232 – Communicable Diseases Research

A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] COVID-19, SARS,

[키워드] 1:1 access acute respiratory syndrome addition age anticipated assigned Asymptomatic Baltimore baseline blinded blocked Bone marrow Boston Care Chloroquine clinically suspected close contact Complete Compound Concomitant concomitant use conducted Contact coronavirus coronavirus disease cough COVID-19 criteria current Date defined determine Diagnosis disorder dissemination Efficacy element eligible eligible participant etiology excluded first dose HCQ Health care worker healthcare worker history Hospitalized household household contact Hydroxychloroquine hypersensitivity incidence index case Infection Intervention leukocyte Los Angele medication moderate multisite neutropenia New Orlean New York City number objective outcome participant PCR-confirmed Pharmacist polymerase chain polymorphonuclear Post-exposure prophylaxis Prevent Primary outcome prolonged exposure Prophylaxis protocol psoriasis randomised randomised controlled trial randomization Randomized receive receiving Registered registry renal impairment responders resulting Sample size SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 PCR test Seattle Secondary objective Seven severe liver disease Shortness of breath statistical statistician stratified study drug study period Study protocol subjective fever syndrome Tamoxifen telehealth therapy Tolerability Treatment Trial Vaccine virus website women
[DOI] 10.1186/s13063-020-04446-4 PMC 바로가기 [Article Type] Letter

Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 1:1 allocation analyzed anticipated approval blinded clinical symptom clinical trial Complete conducted Confirmed Contact Control control group COVID COVID-19 COVID-19 virus criteria dissemination dosage dose double-blind drug Dyspnea Effect element enzyme deficiency Epidemic Fever G6PD healthcare Healthcare professional healthcare professionals history hospital Hydroxychloroquine hypersensitivity independent Infection intervention group Iran Medical Sciences myalgia nausea number objective outcome participant Patient PCR pharmaceutical Pharmacy Placebo placebo-controlled trial polymerase chain reaction Prevent prevention prevention of COVID-19 Primary outcome protocol random randomised randomised controlled trial randomization randomization list Randomized recruitment researcher Sample size statistical status Study protocol Tablet Tehran treatment allocation treatment group Trial Trial registration underlying disease university virus virus infection website
[DOI] 10.1186/s13063-020-04439-3 PMC 바로가기 [Article Type] Letter

Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 1:1 95% CI absence addition administration of hydroxychloroquine Admission aerosol-generating procedures allergy analyzed Anesthesia antibody approved ARMS assigned balanced randomization blind Cancer Cantabria carried CDC Cell Chemoprophylaxis clinical Clinical data clinically coated Committee comparator Comparator group computer-generated control group Controlled Controlled clinical trial Controlled trial coronavirus COVID COVID-19 criteria CURB current detect Determination disease dissemination double blind double-blind dropout rate Efficacy Efficacy and safety element ELISA kit Emergency Endocrine estimate Ethics Euroimmun Evidence evidence of Germany GRADE greater group Health Health authority health-care healthcare personnel Healthcare professional healthcare professionals heart heart failure help hematological high risk hospital Hydroxychloroquine hydroxychloroquine sulfate hygiene Hypothesis ICU IDT IgA IgG IgM and IgG immune immunodeficiency in vitro incidence include Infection inhibit intensive care unit Intervention investigator kidney lactation liver measure Measures Medicine Negative PCR neurological New York number observation period outcome participant PCR performed Personal protective equipment Placebo positive positive SARS-CoV-2 PCR positive serology Pregnancy presenting Prevalence Primary outcome probes product professional Prophylaxis Prospective PROTECT Protective protocol Psychiatric randomised randomised controlled trial randomization Randomized randomized trial RCT receive recruitment reduce reported responsible risk RT-PCR Sample size SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 PCR sequence Seroconversion serological serology severity Significant single center single-center study social distancing Spain Spanish Standard Statistical power status Study protocol subject Support Symptom symptomatic and asymptomatic Tablet Takara Taking Tamoxifen Transmission Treatment two-tailed university Vaccine virus website while
[DOI] 10.1186/s13063-020-04400-4 PMC 바로가기 [Article Type] Letter

A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] COVID-19, SARS,

[키워드] 1:1 age analogue anticipated assigned Asymptomatic blinded bpm Characteristics clinical trial comparator components Contact Controlled trial coronavirus disease COVID-19 COVID-19 symptom COVID19 Date deficiency develop Diabetes Mellitus Diagnosis disease dissemination dose double-blind drug Efficacy Efficiency eight element enrolled enrolment EU Clinical Trial evaluate evaluate the effect exclusion criteria experimental arm female participant Final Glucose haloperidol healthcare healthcare worker Healthcare workers hematological Hemodialysis hepatitis B Hereditary high risk history HIV HIV infection hospital hypersensitivity IgM/IgG immune immunosuppressive incidence Inclusion Infection Inflammatory cytokine Intervention less lymphopenia male melatonin men and women multicenter myasthenia gravis number objective outcome participant Patient PCR Placebo polymerase chain post-symptom onset Premenopausal Prevent prophylactic treatment Prophylaxis protocol Ramón randomisation randomised randomised controlled trial randomization Randomized Rapid test receiving recruited renal failure Research Retinitis rheumatoid arthritis risk RT-PCR Sample size SARS-CoV 2 SARS-CoV-2 SARS-COV-2 infection SAS version 9.4 secondary sequence Seroconversion severe COVID-19 severity of COVID-19 Sex Spain Spanish statistical status stratified study drug Study protocol symptomatic infection symptomatic SARS-CoV-2 infection Treatment Trial two-arm parallel ulcerative colitis understanding urinary pregnancy test Vasculitis website weight women
[DOI] 10.1186/s13063-020-04436-6 PMC 바로가기 [Article Type] Letter

A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 1:1 age Algorithm anonymously APC Arm avoidance Behavioral intent behavioural blinded changes in clinical component control arm control group country COVID-19 COVID-19 outbreak Developed dissemination Effect Effectiveness Effects element eligible English Entertainment-education excluded expected experiment Face masks female FIVE France French Germany Gorilla highest Host hygiene IMPROVE include Interaction Intervention intervention arm investigator investigators item knowledge List experiment male media Medicine Novel coronavirus number objective outcome outcome measure parallel group participant Participants physical contact Placebo platform Prevalence Prevent Primary outcome Prolific Academic protocol question questionnaire randomised controlled trial randomization randomize Randomized Randomized controlled trial Randomly RCT reached receive recruit recruited reduce Registered secondary outcome sequence Sex social distancing Spain Spanish Spread spread of COVID-19 Stanford Study protocol submitted The United States total sample size Treatment treatment group Trial United Kingdom was collected washing hand washing hands website
[DOI] 10.1186/s13063-020-04449-1 PMC 바로가기 [Article Type] Letter

Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 24 hour acute respiratory distress syndrome addition Administered Anakinra anti-IL-1 anti-IL-6 anti-IL-6 receptor antibody Bacterial Belgium binding blinded blockade Blood characterized chest X-ray chimeric clinical Clinical improvement Combination composed Coronavirus infection COVID-19 COVID-19 infection COVID-19 pandemic COVID-19 patient CT scan death defined discharge dissemination dose drug Effectiveness element EudraCT excluded experimental arm factorial design Fungal infection hospital hospital discharge Hospitalized hospitals hypoxia hypoxic respiratory failure ICU IL-1 IL-6 IL-6 blockade IL-6 receptor interleukin 1 blockade interleukin 6 blockade Intravenous injection Invasive mechanical ventilation LDH lymphopenia mechanical ventilation non-invasive ventilation number objective on mechanical ventilation open label Open-label outcome oxygen Oxygenation paO2/fiO2 participant Participants Patient patients with COVID-19 Phase 3 primary end point protocol randomisation randomised randomised controlled trial randomization Randomized receive receptor recruited recruitment Registered response Sample size Serum ferritin siltuximab standard care Standard of care status Study protocol subcutaneous injection supplemental oxygen syndrome System systemic cytokine systemic cytokine release syndrome Tocilizumab treated Trial usual care was selected Web website
[DOI] 10.1186/s13063-020-04453-5 PMC 바로가기 [Article Type] Letter

Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 95% confidence interval Adjusted analysis Administered Admission age alcohol allocation concealment ALT/AST Analysis Arm arrhythmia assigned Beta block-randomization Blood calculated Care center clinical Clinical improvement clinical trial conducted confirmed case control group cough COVID-19 COVID-19 confirmed patient COVID-19 in patient COVID-2019 Cox proportional-hazards model death discharge disease dissemination drug Duration education Effectiveness element eligibility enrolled excluded exclusion criteria fatigue follow-up time hazard headache Health hospital hospital discharge Hospitalization Hydroxychloroquine + Lopinavir/Ritonavir improvement include Interaction Interferon beta-1a Interferon-β 1a Interferon-β 1b intervals intervention group investigator Kaletra Kaplan–Meier laboratory result lactating women Last limit log-rank test Loghman Hakim Hospital Lopinavir Lopinavir/ritonavir masking mechanical ventilation Medical Science Medical Sciences moderate Mortality myalgia nasal NCT04343768 number objective open label Open-label Other outcome oxygen saturation package parallel group participant Patient performed positive pregnant Primary outcome primary outcome measure problem professional protocol pulse-oximetry R software R version 3.6.1 randomization randomization sequence Randomized Randomized controlled trial Randomly reached receive Recigen recruitment refusal regimen Registered Research respiratory rate RT-PCR test Sample SARS-CoV-2 sealed secondary secondary outcome seven-category ordinal scale single center single dose SpO2 sputum production standard care status Study protocol Symptom temperature tested the patient therapeutic three groups time treat treated treatment groups Trial university version 3.6.1 website World Health Organization Ziferon
[DOI] 10.1186/s13063-020-04382-3 PMC 바로가기 [Article Type] Letter

Guidance for otolaryngology health care workers performing aerosol generating medical procedures during the COVID-19 pandemic

Review

Published on 2020-06-032022-10-29
Journal: Journal of Otolaryngology - Head & Neck Surgery [Category] COVID-19, SARS,

[키워드] acute respiratory syndrome aerosol Asymptomatic can be used clinical care Contamination coronavirus Coronavirus disease 2019 COVID-19 COVID-19 pandemic COVID-19 positive patient COVID-19 positive patients doffing donning Face shield Factor Guidance guideline HCW HCWs Health care worker healthcare high risk infected with SARS-CoV-2 infecting Infection Infection prevention level 1 level 3 Local lower airways mitigate mucosa mucosal surfaces otolaryngologist otolaryngology pandemic PAPR Patient patients performed PPE Prevalence procedure protocol recommendation recommendations resources Respirator responsible review risk risk of transmission SARS-CoV-2 short duration surgical test negative virus
[DOI] 10.1186/s40463-020-00429-2 PMC 바로가기 [Article Type] Review

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial

Letter

Published on 2020-06-032022-10-29
Journal: Trials [Category] Coronavirus, SARS,

[키워드] 1:1 active malignancy acute respiratory distress syndrome Administered administration age approval approved ARDS assessment automated Berlin blinded Cell cell suspension cellular changes in chronic liver disease class clinical Clinical diagnosis Clinical outcome clinical outcomes clinical trial comparator Compliance conducted control group Controlled trial COVID 19 COVID-19 COVID-19 pandemic declined defined described determine diagnosis of COVID-19 dissemination Donor Dose escalation driving Effect Efficacy element eligible Elizabeth enrolled ethics committee EudraCT excluded facilitate failure fixed dose hospital ICU incidence Inclusion increase in index individual information infusion intensive care unit Intervention Invasive mechanical ventilation investigator King’s College London London Mesenchymal stem cells Mesenchymal stromal cells MHRA moderate Mortality MSC MSCs NIHR number objective open label Other outcome pandemic PaO participant Patient patient population patients with ARDS PCR test PF ratio Phase 1 Phase 2 Placebo placebo-controlled protocol protocol amendment Public randomised randomised controlled trial REC receiving recruited recruitment repair reported Research respiratory Resuscitation Sample size secondary Secondary objective Secondary outcomes Serious Adverse Events severe ARDS single intravenous infusion SOFA solution Standard steering committee stratified stromal cell Study protocol Therapeutics therapy trauma Treatment Trial triple blinded Trust umbilical United Kingdom university Venous Thromboembolism Ventilation verbal Volume web-based randomisation system website WHO Withdrawal
[DOI] 10.1186/s13063-020-04416-w PMC 바로가기 [Article Type] Letter