LitCovid-sentences  

PubMed:32616067 JSONTXT 14 Projects

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Id Subject Object Predicate Lexical cue
T1 0-146 Sentence denotes ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers:
T2 147-222 Sentence denotes A structured summary of a study protocol for a randomised controlled trial.
T3 223-253 Sentence denotes OBJECTIVES: PRIMARY OBJECTIVE:
T4 254-429 Sentence denotes To determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers.
T5 430-451 Sentence denotes SECONDARY OBJECTIVES:
T6 452-626 Sentence denotes 1) To determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers.
T7 627-1079 Sentence denotes 2) To compare the number of COVID-19 cases between each trial arm on the basis of positive tests (as per current clinical testing methods and/or serology) 3) To compare the percentage of COVID-19 positive individuals with current testing methods versus serologically-proven COVID-19 in each trial arm 4) To compare COVID-19 disease severity in each trial arm 5) To compare recovery time from COVID-19 infection in each trial arm EXPLORATORY OBJECTIVES:
T8 1080-1458 Sentence denotes 1) To determine compliance (as measured by trough pharmacokinetic hydroxychloroquine levels) on COVID-19 positive tests 2) To determine if genetic factors determine susceptibility to COVID-19 disease or response to treatment 3) To determine if blood group determines susceptibility to COVID-19 disease 4) To compare serum biomarkers of COVID-19 disease in each arm TRIAL DESIGN:
T9 1459-1556 Sentence denotes Double-blind, multi-centre, 2-arm (3:3:2 ratio) randomised placebo-controlled trial PARTICIPANTS:
T10 1557-1669 Sentence denotes National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19.
T11 1670-1788 Sentence denotes Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19.
T12 1789-1808 Sentence denotes INCLUSION CRITERIA:
T13 1809-1858 Sentence denotes To be included in the trial the participant MUST:
T14 1859-2152 Sentence denotes 1) Have given written informed consent to participate 2) Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care EXCLUSION CRITERIA:
T15 2153-2228 Sentence denotes The presence of any of the following will mean participants are ineligible:
T16 2229-2790 Sentence denotes 1) Known COVID-19 positive test at baseline (if available) 2) Symptomatic for possible COVID-19 at baseline 3) Known hypersensitivity reaction to hydroxychloroquine, chloroquine or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert's syndrome is permitted) 10) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 11) Currently taking any of the following contraindicated medications:
T17 2791-3515 Sentence denotes Digoxin, Chloroquine, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Ciprofloxacin, Clarithromycin, Prochlorperazine, Fluconazole 12) Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine 13) Currently breastfeeding 14) Unable to be followed-up during the trial 15) Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit 16) Not able to use or have access to a modern phone device/web-based technology 17) Any other clinical reason which may preclude entry in the opinion of the investigator INTERVENTION AND COMPARATOR:
T18 3516-3696 Sentence denotes Interventions being evaluated are: A) Daily hydroxychloroquine or B) Weekly hydroxychloroquine or C) Placebo The maximum treatment period is approximately 13 weeks per participant.
T19 3697-3869 Sentence denotes Hydroxychloroquine-identical matched placebo tablets will ensure that all participants are taking the same number and dosing regimen of tablets across the three trial arms.
T20 3870-3936 Sentence denotes There is no variation in the dose of hydroxychloroquine by weight.
T21 3937-4036 Sentence denotes The dosing regimen for the three arms of the study (A, B, C) are described in further detail below.
T22 4037-4043 Sentence denotes Arm A:
T23 4044-4142 Sentence denotes Active Hydroxychloroquine (- daily dosing and placebo-matched hydroxychloroquine - weekly dosing).
T24 4143-4148 Sentence denotes Form:
T25 4149-4163 Sentence denotes Tablets Route:
T26 4164-4169 Sentence denotes Oral.
T27 4170-4189 Sentence denotes Dose and Frequency:
T28 4190-4216 Sentence denotes Active hydroxychloroquine:
T29 4217-4226 Sentence denotes Days 1-2:
T30 4227-4313 Sentence denotes Loading phase - 400mg (2 x 200mg tablets) taken twice a day for 2 days Days 3 onwards:
T31 4314-4446 Sentence denotes Maintenance Phase - 200mg (1 x 200mg tablet) taken once daily, every day for 90 days (~3 months) Matched Placebo hydroxychloroquine:
T32 4447-4462 Sentence denotes Days 3 onwards:
T33 4463-4583 Sentence denotes Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7th day) for 90 days (~3 months) Arm B:
T34 4584-4688 Sentence denotes Active Hydroxychloroquine (- weekly dosing and placebo matched hydroxychloroquine - daily dosing.) Form:
T35 4689-4703 Sentence denotes Tablets Route:
T36 4704-4709 Sentence denotes Oral.
T37 4710-4729 Sentence denotes Dose and Frequency:
T38 4730-4756 Sentence denotes Active hydroxychloroquine:
T39 4757-4766 Sentence denotes Days 1-2:
T40 4767-4853 Sentence denotes Loading Phase - 400mg (2 x 200mg tablets) taken twice daily for 2 days Days 3 onwards:
T41 4854-5019 Sentence denotes Maintenance Phase - 400mg (2 x 200mg tablets) taken once a week on the same day each week (every 7th day) for 90 days (~3 months) Matched Placebo hydroxychloroquine:
T42 5020-5035 Sentence denotes Days 3 onwards:
T43 5036-5112 Sentence denotes Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Arm C:
T44 5113-5226 Sentence denotes Matched placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing.) Form:
T45 5227-5233 Sentence denotes Table.
T46 5234-5240 Sentence denotes Route:
T47 5241-5246 Sentence denotes Oral.
T48 5247-5257 Sentence denotes Frequency:
T49 5258-5308 Sentence denotes Matched placebo hydroxychloroquine - daily dosing:
T50 5309-5318 Sentence denotes Days 1-2:
T51 5319-5389 Sentence denotes Loading Phase - 2 tablets taken twice daily for 2 days Days 3 onwards:
T52 5390-5511 Sentence denotes Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Matched placebo hydroxychloroquine - weekly dosing:
T53 5512-5527 Sentence denotes Days 3 onwards:
T54 5528-5737 Sentence denotes Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7th day) for 90 days (~3 months) A schematic of the dosing schedule can be found in the full study protocol (Additional File 1).
T55 5738-5752 Sentence denotes MAIN OUTCOMES:
T56 5753-5893 Sentence denotes Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test) RANDOMISATION:
T57 5894-6059 Sentence denotes Participants will be randomised to either hydroxychloroquine dosed daily with weekly placebo, HCQ dosed weekly with daily placebo, or placebo dosed daily and weekly.
T58 6060-6204 Sentence denotes Randomisation will be in a 3:3:2 ratio [hydroxychloroquine-(daily), hydroxychloroquine-(weekly), placebo], using stratified block randomisation.
T59 6205-6279 Sentence denotes Random block sizes will be used, and stratification will be by study site.
T60 6280-6299 Sentence denotes BLINDING (MASKING):
T61 6300-6438 Sentence denotes Participants and trial investigators consenting participants, delivering trial assessments and procedures will be blinded to intervention.
T62 6439-6478 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T63 6479-6642 Sentence denotes A sufficient number of participants will be enrolled so that approximately 1000 participants in total will have data suitable for the primary statistical analysis.
T64 6643-6790 Sentence denotes It is anticipated that approximately 1,200 participants will need to be enrolled in total, to allow for a 20% dropout over the period of the trial.
T65 6791-6975 Sentence denotes This would result in approximately 450:450:300 participants randomised to hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo daily and weekly.
T66 6976-6989 Sentence denotes TRIAL STATUS:
T67 6990-7055 Sentence denotes V 1.0, 7th April 2020 EU Clinical Trials Register EudraCT Number:
T68 7056-7092 Sentence denotes 2020-001331-26 Date of registration:
T69 7093-7161 Sentence denotes 14th April 2020 Trial registered before first participant enrolment.
T70 7162-7228 Sentence denotes Trial site is Cambridge University Hospitals NHS Foundation Trust.
T71 7229-7266 Sentence denotes Recruitment started on 11th May 2020.
T72 7267-7323 Sentence denotes It is anticipated that the trial will run for 12 months.
T73 7324-7384 Sentence denotes The recruitment end date cannot yet be accurately predicted.
T74 7385-7399 Sentence denotes FULL PROTOCOL:
T75 7400-7508 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T76 7509-7689 Sentence denotes In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
T77 7690-7774 Sentence denotes The study protocol has been reported in accordance with the Standard Protocol Items:
T78 7775-7866 Sentence denotes Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).