LitCovid-sentences  

PubMed:33213530 JSONTXT 15 Projects

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Id Subject Object Predicate Lexical cue
T1 0-88 Sentence denotes Glasgow Early Treatment Arm Favirpiravir (GETAFIX) for adults with early stage COVID-19:
T2 89-164 Sentence denotes A structured summary of a study protocol for a randomised controlled trial.
T3 165-176 Sentence denotes OBJECTIVES:
T4 177-369 Sentence denotes The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who have early stage disease, compared to current standard of care.
T5 370-768 Sentence denotes This study will also provide an important opportunity to investigate the safety and tolerability of favipiravir, the pharmacokinetic and pharmacodynamic profile of this drug and mechanisms of resistance in the context of COVID-19 infection, as well as the effect of favipiravir on hospitalisation duration and the post COVID-19 health and psycho-social wellbeing of patients recruited to the study.
T6 769-899 Sentence denotes TRIAL DESIGN: GETAFIX is an open label, parallel group, two arm phase II/III randomised trial with 1:1 treatment allocation ratio.
T7 900-1076 Sentence denotes Patients will be randomised to one of two arms and the primary endpoint will assess the superiority of favipiravir plus standard treatment compared to standard treatment alone.
T8 1077-1090 Sentence denotes PARTICIPANTS:
T9 1091-1252 Sentence denotes This trial will recruit adult patients with confirmed positive valid COVID-19 test, who are not pregnant or breastfeeding and have no prior major co-morbidities.
T10 1253-1372 Sentence denotes This is a multi-centre trial, patients will be recruited from in-patients and outpatients from three Glasgow hospitals:
T11 1373-1468 Sentence denotes Royal Alexandra Hospital; Queen Elizabeth University Hospital; and the Glasgow Royal Infirmary.
T12 1469-1518 Sentence denotes Patients must meet all of the following criteria:
T13 1519-1521 Sentence denotes 1.
T14 1522-1558 Sentence denotes Age 16 or over at time of consent 2.
T15 1559-1606 Sentence denotes Exhibiting symptoms associated with COVID-19 3.
T16 1607-1656 Sentence denotes Positive for SARS-CoV-2 on valid COVID-19 test 4.
T17 1657-1891 Sentence denotes Point 1, 2, 3, or 4 on the WHO COVID-19 ordinal severity scale at time of randomisation. (Asymptomatic with positive valid COVID-19 test, Symptomatic Independent, Symptomatic assistance needed, Hospitalized, with no oxygen therapy) 5.
T18 1892-2020 Sentence denotes Have >=10% risk of death should they be admitted to hospital as defined by the ISARIC4C risk index: https://isaric4c.net/risk 6.
T19 2021-2064 Sentence denotes Able to provide written informed consent 7.
T20 2065-2126 Sentence denotes Negative pregnancy test (women of childbearing potential*) 8.
T21 2127-2243 Sentence denotes Able to swallow oral medication Patients will be excluded from the trial if they meet any of the following criteria:
T22 2244-2246 Sentence denotes 1.
T23 2247-2327 Sentence denotes Renal impairment requiring, or likely to require, dialysis or haemofiltration 2.
T24 2328-2356 Sentence denotes Pregnant or breastfeeding 3.
T25 2357-2595 Sentence denotes Of child bearing potential (women), or with female partners of child bearing potential (men) who do not agree to use adequate contraceptive measures for the duration of the study and for 3 months after the completion of study treatment 4.
T26 2596-2632 Sentence denotes History of hereditary xanthinuria 5.
T27 2633-2718 Sentence denotes Other patients judged unsuitable by the Principal Investigator or sub-Investigator 6.
T28 2719-2794 Sentence denotes Known hypersensitivity to favipiravir, its metabolites or any excipients 7.
T29 2795-2993 Sentence denotes Severe co-morbidities including: patients with severe hepatic impairment, defined as:  • greater than Child-Pugh grade A  • AST or ALT > 5 x ULN  • AST or ALT >3 x ULN and Total Bilirubin > 2xULN 8.
T30 2994-3067 Sentence denotes More than 96 hours since first positive COVID-19 test sample was taken 9.
T31 3068-3250 Sentence denotes Unable to discontinue contra-indicated concomitant medications This is a multi-centre trial, patients will be recruited from in-patients and outpatients from three Glasgow hospitals:
T32 3251-3346 Sentence denotes Royal Alexandra Hospital; Queen Elizabeth University Hospital; and the Glasgow Royal Infirmary.
T33 3347-3375 Sentence denotes INTERVENTION AND COMPARATOR:
T34 3376-3537 Sentence denotes Patients randomised to the experimental arm of GETAFIX will receive standard treatment for COVID-19 at the discretion of the treating clinician plus favipiravir.
T35 3538-3639 Sentence denotes These patients will receive a loading dose of favipiravir on day 1 of 3600mg (1800mg 12 hours apart).
T36 3640-3778 Sentence denotes On days 2-10, patients in the experimental arm will receive a maintenance dose of favipiravir of 800mg 12 hours apart (total of 18 doses).
T37 3779-3928 Sentence denotes Patients randomised to the control arm of the GETAFIX trial will receive standard treatment for COVID-19 at the discretion of the treating clinician.
T38 3929-3943 Sentence denotes MAIN OUTCOMES:
T39 3944-4164 Sentence denotes The primary outcome being assessed in the GETAFIX trial is the efficacy of favipiravir in addition to standard treatment in patients with COVID-19 in reducing the severity of disease compared to standard treatment alone.
T40 4165-4270 Sentence denotes Disease severity will be assessed using WHO COVID 10 point ordinal severity scale at day 15 +/- 48 hours.
T41 4271-4383 Sentence denotes All randomised participants will be followed up until death or 60 days post-randomisation (whichever is sooner).
T42 4384-4398 Sentence denotes RANDOMISATION:
T43 4399-4522 Sentence denotes Patients will be randomised 1:1 to the experimental versus control arm using computer generated random sequence allocation.
T44 4523-4615 Sentence denotes A minimisation algorithm incorporating a random component will be used to allocate patients.
T45 4616-4908 Sentence denotes The factors used in the minimisation will be: site, age (16-50/51-70/71+), history of hypertension or currently obsess (BMI>30 or obesity clinically evident; yes/no), 7 days duration of symptoms (yes/no/unknown), sex (male/female), WHO COVID-19 ordinal severity score at baseline (1/2or 3/4).
T46 4909-4928 Sentence denotes BLINDING (MASKING):
T47 4929-4975 Sentence denotes No blinding will be used in the GETAFIX trial.
T48 4976-5061 Sentence denotes Both participants and those assessing outcomes will be aware of treatment allocation.
T49 5062-5101 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T50 5102-5165 Sentence denotes In total, 302 patients will be randomised to the GETAFIX trial:
T51 5166-5221 Sentence denotes 151 to the control arm and 151 to the experimental arm.
T52 5222-5337 Sentence denotes There will be an optional consent form for patients who may want to contribute to more frequent PK and PD sampling.
T53 5338-5446 Sentence denotes The maximum number of patients who will undergo this testing will be sixteen, eight males and eight females.
T54 5447-5661 Sentence denotes This option will be offered to all patients who are being treated in hospital at the time of taking informed consent, however only patients in the experimental arm of the trial will be able to undergo this testing.
T55 5662-5675 Sentence denotes TRIAL STATUS:
T56 5676-5740 Sentence denotes The current GETAFIX protocol is version 4.0 12th September 2020.
T57 5741-5860 Sentence denotes GETAFIX opened to recruitment on 26th October 2020 and will recruit patients over a period of approximately six months.
T58 5861-6118 Sentence denotes TRIAL REGISTRATION: GETAFIX was registered on the European Union Drug Regulating Authorities Clinical Trials (EudraCT) Database on 15th April 2020; Reference number 2020-001904-41 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001904-41/GB ).
T59 6119-6249 Sentence denotes GETAFIX was registered on ISRCTN on 7th September 2020; Reference number ISRCTN31062548 ( https://www.isrctn.com/ISRCTN31062548 ).
T60 6250-6264 Sentence denotes FULL PROTOCOL:
T61 6265-6373 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T62 6374-6554 Sentence denotes In the interest in 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.
T63 6555-6639 Sentence denotes The study protocol has been reported in accordance with the Standard Protocol Items:
T64 6640-6735 Sentence denotes Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (see Additional file 2).