LitCovid-sentences  

PubMed:32907635 JSONTXT 20 Projects

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Id Subject Object Predicate Lexical cue
T1 0-188 Sentence denotes Enoxaparin for primary thromboprophylaxis in ambulatory patients with coronavirus disease-2019 (the OVID study): a structured summary of a study protocol for a randomized controlled trial.
T2 189-200 Sentence denotes OBJECTIVES:
T3 201-512 Sentence denotes The OVID study will demonstrate whether prophylactic-dose enoxaparin improves survival and reduces hospitalizations in symptomatic ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.
T4 513-526 Sentence denotes TRIAL DESIGN:
T5 527-623 Sentence denotes The OVID study is conducted as a multicentre open-label superiority randomised controlled trial.
T6 624-637 Sentence denotes PARTICIPANTS:
T7 638-659 Sentence denotes Inclusion Criteria 1.
T8 660-748 Sentence denotes Signed patient informed consent after being fully informed about the study's background.
T9 749-751 Sentence denotes 2.
T10 752-876 Sentence denotes Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment.
T11 877-879 Sentence denotes 3.
T12 880-992 Sentence denotes Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature >37.5° C.
T13 993-995 Sentence denotes 4.
T14 996-1174 Sentence denotes Ability of the patient to travel to the study centre by private transportation, performed either by an accompanying person from the same household or by the patient themselves 5.
T15 1175-1306 Sentence denotes Ability to comply with standard hygiene requirements at the time of in-hospital visit, including a face mask and hand disinfectant.
T16 1307-1309 Sentence denotes 6.
T17 1310-1501 Sentence denotes Ability to walk from car to study centre or reach it by wheelchair transport with the help of an accompanying person from the same household also complying with standard hygiene requirements.
T18 1502-1504 Sentence denotes 7.
T19 1505-1689 Sentence denotes Ability to self-administer prefilled enoxaparin injections after instructions received at the study centre or availability of a person living with the patient to administer enoxaparin.
T20 1690-1711 Sentence denotes Exclusion Criteria 1.
T21 1712-1912 Sentence denotes Any acute or chronic condition posing an indication for anticoagulant treatment, e.g. atrial fibrillation, prior venous thromboembolism (VTE), acute confirmed symptomatic VTE, acute coronary syndrome.
T22 1913-1915 Sentence denotes 2.
T23 1916-2067 Sentence denotes Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history, comorbidity or predisposing strong risk factors for thrombosis:  a.
T24 2068-2444 Sentence denotes Any of the following events occurring in the prior 30 days: fracture of lower limb, hospitalization for heart failure, hip/knee replacement, major trauma, spinal cord injury, stroke,  b. previous VTE,  c. histologically confirmed malignancy, which was diagnosed or treated (surgery, chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or inoperable.
T25 2445-2447 Sentence denotes 3.
T26 2448-2714 Sentence denotes Any clinically relevant bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 30 days prior to randomization or sign of acute bleeding.
T27 2715-2717 Sentence denotes 4.
T28 2718-2830 Sentence denotes Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute intracranial haemorrhage.
T29 2831-2833 Sentence denotes 5.
T30 2834-2938 Sentence denotes Haemoglobin <8 g/dL and platelet count <50 x 109 cells/L confirmed by recent laboratory test (<90 days).
T31 2939-2941 Sentence denotes 6.
T32 2942-3073 Sentence denotes Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy.
T33 3074-3076 Sentence denotes 7.
T34 3077-3239 Sentence denotes Severe renal insufficiency (baseline creatinine clearance <30 mL/min calculated using the Cockcroft-Gault formula) confirmed by recent laboratory test (<90 days).
T35 3240-3242 Sentence denotes 8.
T36 3243-3360 Sentence denotes Contraindications to enoxaparin therapy, including prior heparin-induced thrombocytopenia and known hypersensitivity.
T37 3361-3363 Sentence denotes 9.
T38 3364-3405 Sentence denotes Current use of dual antiplatelet therapy.
T39 3406-3409 Sentence denotes 10.
T40 3410-3478 Sentence denotes Participation in other interventional studies over the past 30 days.
T41 3479-3482 Sentence denotes 11.
T42 3483-3603 Sentence denotes Non-compliance or inability to adhere to treatment or lack of a family environment or support system for home treatment.
T43 3604-3607 Sentence denotes 12.
T44 3608-3706 Sentence denotes Cognitive impairment and/or inability to understand information provided in the study information.
T45 3707-3834 Sentence denotes Patient enrolment will take place at seven Swiss centres, including five university hospitals and two large cantonal hospitals.
T46 3835-3863 Sentence denotes INTERVENTION AND COMPARATOR:
T47 3864-4038 Sentence denotes Patients randomized to the intervention group will receive subcutaneous enoxaparin at the recommended dose of 4,000 IU anti-Xa activity (40 mg/0.4 ml) once daily for 14 days.
T48 4039-4115 Sentence denotes Patients randomized to the comparator group will receive no anticoagulation.
T49 4116-4130 Sentence denotes MAIN OUTCOMES:
T50 4131-4244 Sentence denotes Primary outcome: a composite of any hospitalization or all-cause death occurring within 30 days of randomization.
T51 4245-5081 Sentence denotes SECONDARY OUTCOMES: (i) a composite of cardiovascular events, including deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic stroke within 14 days, 30 days, and 90 days of randomization; (ii) each component of the primary efficacy outcome, within 14 days, 30 days, and 90 days of randomization; (iii) net clinical benefit (accounting for the primary efficacy outcome, composite cardiovascular events, and major bleeding), within 14 days, 30 days, and 90 days of enrolment; (iv) primary efficacy outcome, within 14 days, and 90 days of enrolment; (v) disseminated intravascular coagulation (ISTH criteria, in-hospital diagnosis) within 14 days, 30 days, and 90 days of enrolment.
T52 5082-5096 Sentence denotes RANDOMISATION:
T53 5097-5158 Sentence denotes Patients will undergo block stratified randomization (by age:
T54 5159-5276 Sentence denotes 50-70 vs. >70 years; and by study centre) with a randomization ratio of 1:1 with block sizes varying between 4 and 8.
T55 5277-5504 Sentence denotes Randomization will be performed after the signature of the informed consent for participation and the verification of the eligibility criteria using the electronic data capture software (REDCAP, Vanderbilt University, v9.1.24).
T56 5505-5524 Sentence denotes BLINDING (MASKING):
T57 5525-5587 Sentence denotes In this open-label study, no blinding procedures will be used.
T58 5588-5627 Sentence denotes NUMBERS TO BE RANDOMISED (SAMPLE SIZE):
T59 5628-5709 Sentence denotes The sample size calculation is based on the parameters α = 0.05 (2-sided), power:
T60 5710-5812 Sentence denotes 1-β = 0.8, event rate in experimental group, pexp = 0.09 and event rate in control group, pcon = 0.15.
T61 5813-5852 Sentence denotes The resulting total sample size is 920.
T62 5853-6001 Sentence denotes To account for potential dropouts, the total sample size was fixed to 1000 with 500 patients in the intervention group and 500 in the control group.
T63 6002-6015 Sentence denotes TRIAL STATUS:
T64 6016-6052 Sentence denotes Protocol version 1.0, 14 April 2020.
T65 6053-6109 Sentence denotes Protocol version 3.0, 18 May 2020 Recruiting start date:
T66 6110-6120 Sentence denotes June 2020.
T67 6121-6145 Sentence denotes Last Patient Last Visit:
T68 6146-6157 Sentence denotes March 2021.
T69 6158-6177 Sentence denotes TRIAL REGISTRATION:
T70 6178-6234 Sentence denotes ClinicalTrials.gov Identifier: NCT04400799 First Posted:
T71 6235-6267 Sentence denotes May 26, 2020 Last Update Posted:
T72 6268-6296 Sentence denotes July 16, 2020 FULL PROTOCOL:
T73 6297-6405 Sentence denotes The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
T74 6406-6586 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.